Executive Order No. 821, s.

2009
MALACAANG MANILA

EXECUTIVE ORDER NO. 821 PRESCRIBING THE MAXIMUM DRUG RETAIL PRICES FOR SELECTED DRUGS AND MEDICINES THAT ADDRESS DISEASES THAT ACCOUNT FOR THE LEADING CAUSES OF MORBIDITY AND MORTALITY WHEREAS, access to affordable medicines for diseases that account for the leading causes of morbidity and mortality is critical to improve the health and productivity of Filipinos, prevent impoverishment of families due to high cost of health care and thereby achieve the Millennium Development Goals and National Objectives for Health; WHEREAS, Chapter 3, Section 17, of Republic Act 9502, otherwise known as The Universally Accessible Cheaper and Quality Medicines Act of 2008, and its implementing rules and regulations provide that the President of the Philippines, upon recommendation of the Secretary of the Department of Health, shall have the power to impose maximum retail prices over any or all drugs and medicines as enumerated and provided for within the law; WHEREAS, in an effort to make medicines affordable and accessible to the majority of Filipinos, and acting on the conviction that health is a basic human right, the President ordered the Department of Health and the Department of Trade and Industry to determine and recommend Maximum Drug Retail Prices (MDRP); WHEREAS, the determination of the MDRP is premised on the following criteria: (a) conditions that address public health priorities especially those that account for the leading causes of morbidity and mortality; (b) drugs that have high price differentials/arbitrage compared to international prices; (c) drugs that have limited competition in terms of lack of generic counterparts or lack of market access to these products; (d) drugs where the innovator product is the most expensive yet most prescribed and/or dispensed in the market; and (e) the conditions as stated in Sections 19 (2) of Republic Act No. 9502, among others; WHEREAS, various stakeholders, academic institutions, including the Advisory Council for Medicine Price Regulation created pursuant to Section 18 of RA 9502, were involved in the process of consultation in the selection of the initial twenty-one (21) drugs and medicines for the imposition of MDRP; WHEREAS, as a consequence of the Presidents appeal to pharmaceutical companies during the process of consultation, many of these companies voluntarily undertook to reduce by at least fifty per cent (50%) the prices of sixteen (16) drugs that address diseases of public health concern originally included in the MDRP, such as hypertension, diabetes, common bacterial infections, amoebiasis (a leading cause of diarrhea), cancers (like leukemia, the number one

pediatric cancer killer) and the like. In addition, these pharmaceutical companies also undertook to reduce by about ten to fifty per cent (10%-50%) the prices of twenty-two (22) other drugs and medicines not included in the initial list recommended by the DOH and DTI. The reduction of the prices of these drugs and medicines shall commence on August 15, 2009 and shall be fully implemented by September 15, 2009; WHEREAS, of the original drugs and medicines recommended for MDRP, only five (5) are not compliant with the rates proposed by DOH and DTI; NOW THEREFORE, I, GLORIA MACAPAGAL-ARROYO, President of the Republic of the Philippines, by the powers vested in me by law, do hereby impose the Maximum Drug Retail Prices over the following active ingredients, including the indicated specific preparations registered and available in the market: Section 1. List of Medicines and Corresponding Maximum Drug Retail Price (MDRP). ACTIVE INGREDIENT/ MOLECULE

DOSAGE STRENGTH AND FORM

MDRP (PhP)

ANTI-HYPERTENSIVE 1. Amlodipine (including 2.5 mg tablet its S-isomer and all salt form) 5 mg tablet 10 mg tablet ANTI-CHOLESTEROL 2. Atorvastatin 10 mg film-coated tablet 20 mg film-coated tablet 40 mg film-coated tablet 80 mg film-coated tablet Amlodipine besilate 5 mg + Atorvastatin calcium 10 mg tablet Amlodipine besilate 5 mg + Atorvastatin calcium 20 mg tablet Amlodipine besilate 5 mg + Atorvastatin calcium 40 mg tablet Amlodipine besilate 5 mg + Atorvastatin calcium 80 mg tablet Amlodipine besilate 10 mg + Atorvastatin calcium 10 mg tablet Amlodipine besilate 10 mg + Atorvastatin calcium 20 mg tablet Amlodipine besilate 10 mg + Atorvastatin calcium 40 mg tablet Amlodipine besilate 10 mg + Atorvastatin calcium 80 mg tablet

9.60

22.85 38.50 34.45 39.13 50.50 50.63 45.75 66.25 84.42 89.99 51.13 73.25 91.79 91.79

ANTIBIOTIC/ ANTIBACTERIAL 3. Azithromycin and all 250 mg tablet its Salt form 200 mg/5 ml_ powder for suspension (15 mL) 200 mg/5 mL powder for suspension (22.50 mL) 500 mg tablet 500 mg vial for injection 2 g granules ANTI-NEOPLASTICS/ ANTI-CANCER 4. Cytarabine 100 mg/ mL ampul/vial (IV/SC) 100 mg/ mL ampul/vial (IV/SC) (5mL) or 500 mg vial 100 mg/ mL ampul/vial (IV/SC) (10mL) or 1g vial 20 mg/mL (5mL) ampul/vial for injection 5. Doxorubicin and all its 10 mg powder vial for injection Salt form 50 mg powder vial for injection

108.50 427.50 638.00 151.43 992.50 468.00 240.00 900.00 1800.00 1980.00 1465.75 2265.74

Section 2. APPLICABILITY. a. This Order shall apply to all medicines covered under Section 1 which are currently BFADregistered and are available in the market. b. The MDRP of all drugs and medicines stated herein shall be imposed in all retail outlets, public or private, including drugstores, hospitals and hospital pharmacies, health maintenance organizations (HMOs), convenience stores and supermarkets and the like. b.1. Price differentials as an effect of this Order shall be shouldered by the corresponding manufacturer/trader/importer. b.2. No public or private entity or person shall be allowed to sell, reimburse, or demand from the public or patients payment or compensation higher than the MDRP. c. This Order shall also apply to government agencies, offices and instrumentalities procuring, acquiring and reimbursing drugs and medicines covered in Section 1 hereof. c.1. The prescribed MDRP shall serve as the ceiling for the procurement of the herein enumerated list of drugs by the national agencies, local government units, and all other government entities including but not limited to the Philippine Charity Sweepstakes Office (PCSO) and the Philippine Amusement and Gaming Corporation (PAGCOR).

c.2. The prescribed MDRP shall serve as the ceiling for the procurement of the said enumerated list of drugs by government hospitals including the Philippine General Hospital, hospitals managed by the Department of Health including specialty centers, hospitals under the auspices of the Department of National Defense and the Philippine National Police, government-owned and controlled hospital corporations, local government hospitals, and all other types of government hospitals. c.3. The prescribed MDRP shall serve as the ceiling for the retail price of the said enumerated list of drugs of all drug consignment arrangements entered into by government hospitals including government-owned and controlled hospital corporations and local government units, and all other government entities. c.4. The prescribed MDRP shall serve as the ceiling for the reimbursement of the said enumerated list of drugs by the Philippine Health Insurance Corporation, the Social Security System and the Government Services Insurance System and all government entities reimbursing drugs and medicines including the PCSO. Section 3. IMPLEMENTATION. a. The Department of Health is hereby ordered to put in place all the necessary policies and systems to fully implement this Order. b. The Bureau of Food and Drugs (BFAD) shall immediately act upon any application for registration of drugs and medicines listed above within fifteen (15) days upon its filing; thereafter, the approval or disapproval of the Certificate of Product Registration should be released within ninety (90) days. c. Ail government-owned and controlled television and radio stations are hereby ordered to provide all necessary support to DOH in disseminating the list of drugs, their MDRPs, and such other information as required. d. All other agencies of government, national and local, including Government-Owned Controlled Corporations (GOCCs) and Government Funding Institutions (GFIs) are hereby ordered to provide all necessary support to DOH for the enforcement and implementation of, including the dissemination of information, as well as monitoring compliance with this Order. Section 4. VIOLATIONS AND CIRCUMVENTION OF THE MDRP. Any actions construed as circumventing or violating the intent of this Order shall be dealt with accordingly. Section 5. REVIEW. The list of medicines and their corresponding MDRPs shall be subject for review after three (3) to six (6) months by the DOH and as may be recommended thereafter upon the effectivity of this Order or as often as necessary as determined by the Secretary of Health. Section 6. TRANSITION. The period from the issuance of this Order up to August 15, 2009 shall constitute the transition period in which appropriate packaging, labeling, and disposition of existing inventory should be accomplished.

Thereafter, regardless of extent of existing inventory and compliance with packaging and labeling requirements, strict implementation of the MDRP and this Order shall be enforced. Section 7. REPEALING CLAUSE. All executive issuances, orders, rules and regulations or parts thereof inconsistent with this Executive Order are hereby revoked or modified accordingly. Section 8. EFFECTIVITY. This Order shall immediately be published in at least two (2) newspapers of general circulation and shall take effect on August 15, 2009. DONE on this 27th day of July in the Year of Our Lord Two Thousand and Nine. (Sgd.) GLORIA MACAPAGAL-ARROYO By the President:
(Sgd.) EDUARDO R. ERMITA

Executive Secretary

DOH Administrative Order No. 56, s. 1989

Department of Health OFFICE OF THE SECRETARY Manila

January 3, 1989 ADMINISTRATIVE ORDER No. 56 s. 1989 SUBJECT : Revised Regulations for the Licensing of Drug Establishments and Outlets Pursuant to Section 26(a) in relation to Section 21(a) and 11(k) of Republic Act No. 3720, known as the Foods, Drugs and Devices, and Cosmetics Act as amended by Executive Order No. 175 s. 1987 and consistent with Republic Act No. 6675, known as the Generic Act of 1988, the following regulations are hereby promulgated governing drug establishments and drug outlets under the Bureau of Food and Drugs (BFAD). In accordance with Section 3 Paragraphs 5 and 6 of R.A. 6675, any organization, company or business establishments in the pharmaceutical industry shall fall under the following general classification:

I. Drug Establishment means any organization or company involved in the manufacture, importation, repacking and/or distribution of drugs or medicines. This is covered by Chapter I below. II. Drug Outlet means drugstore, pharmacy, and other business establishment which sells drugs or medicines. This is covered by Chapter II below. CHAPTER I Drug Establishment 1. Definition of Different Types of Drug Establishments

1.1 Drug Manufacturer means any establishment engaged in operations involved in the production of a drug, including propagation, processing, compounding, finishing, filling, packing, repacking, altering, ornamenting and labelling with the end in view of storage, distribution or sale of the product; provided that for the purpose of this regulation the compounding and filling of prescriptions in drugstores and hospital pharmacies shall not be considered as production operations. 1.2 Drug Trader means any establishment which is a registered owner of the drug product, procures the raw materials and packaging components, and provides the production monographs, quality control standards and procedures, but sub-contracts the manufacture of such product to a licensed manufacturer. In addition, a trader may also engage in distribution, and/or marketing of its products. 1.3 Drug Distributor/Importer means any establishment that imports raw materials, active ingredients and/or finished products for its own use or for wholesale distribution to other drug establishments or outlets. 1.4 Drug Distributor/Exporter means any drug establishment that exports raw materials, active ingredients and/or finished products to another country. 1.5 Drug Distributor/Wholesaler means any drug establishment that procures raw materials, active ingredients and/or finished products from local establishments for local distribution on wholesale basis. 2. 2.1 Standards and Requirements for License To Operate (LTO) General Requirements

2.1.1 Application any person desiring to operate or establish a drug establishment shall file with the BFAD an application supported by the following documents:

2.1.1.1 A standard petition form containing among others the name, age, citizenship and a passport size picture (5 x 5 cm.) of the petitioner and other pertinent circumstances pertaining to the proposed drug establishment including the place where it is to be established. 2.1.1.2 Proof of registration as an establishment, i.e.:

(a) For single proprietorship; an authenticated photocopy of the Certificate of Business Name Registration issued by the Bureau of Domestic Trade (BDT) of the Department of Trade and Industry. (b) For partnerships, corporations and other juridical persons; authenticated photocopies of the Certificate of Registration issued by the Securities and Exchange Commission (SEC) and the Articles of Incorporation or partnership. 2.1.1.3 A valid Certificate of Registration of the establishments Filipino pharmacist issued by the Professional Regulation Commission (PRC). 2.1.1.4 A certificate of attendance to a BFAD-sponsored accredited Seminar on Licensing of Drug Establishments. 2.1.1.5 (a) it. (b) An Affidavit of Undertaking providing that the applicant shall: change the establishments name if there is already a validly registered name similar to

display the duly approved LTO in a conspicuous place within the establishment.

(c) notify BFAD in case of any change in the circumstances described in the application such as: change of location, change of pharmacist, change in drug products. 2.1.1.6 List of products to be manufactured or distributed identified by their generic names and brand names, if any. 2.1.1.7 An authenticated photocopy of Contract of Lease for the space to be occupied if the applicant does not own it. 2.1.2 A Certificate of continuing compliance with specific technical requirements (to be specified by BFAD according to section 2.2 below). 2.1.3 A Batch Distribution Record Book duly registered with BFAD.

2.1.4 A contingency plan or procedure for a systematic, effective and prompt recall in case any of its products is found violative and ordered recalled from the market by BFAD.

2.1.5 An orderly and secure system of filing up to date invoices from suppliers and buyers identifying lot numbers or batch numbers of manufacturers stock pursuant to BFAD Memo Circular No. 001 s. 1983. 2.2 Specific Requirements:

Any entity applying for a LTO as a drug manufacturer, drug trader or drug distributor shall be required to demonstrate its capacity to perform adequately as such in a manner that satisfactorily assures the safety, efficacy and quality of its drug products. It shall be required to conform with the following relevant standards and requirements specific for each category, in addition to the above general requirements: 2.2.1 Drug Manufacturers

2.2.1.1 Guidelines on Current Good Manufacturing Practices provided for under A.O No. 220 s. 1974, including location, building and floor plans, and any additional guidelines issued by BFAD; 2.2.1.2 Minimum standards for pharmaceutical manufacturing equipment/machines described in Annex A; 2.2.1.3 Minimum standards for quality control facilities described in Annex B;

2.2.1.4 If importing raw materials, active ingredients and/or finished products for use in manufacture of drug products, a certificate that the manufacturer is registered in the country of origin, duly authenticated by the territorial Philippine Consulate, and evidence that the manufacturer meets BFAD standards for local manufacturers. If inspection of the foreign manufacturer by BFAD is necessary, the cost of inspection shall be borne by the applicant establishment. 2.2.2 Drug Traders

2.2.2.1 A valid contract agreement with a BFAD-Licensed manufacturer containing a stipulation that both the drug trader and the manufacturer are jointly responsible for the quality of the product; 2.2.2.2 If importing raw materials, active ingredients and/or finished products for the use in the manufacture of drug products, a certificate that the manufacturer is registered with the country of origin, duly authenticated by the territorial Philippine Consulate, and evidence that the manufacturer meets BFAD standards for local manufacturers. If inspection of the foreign manufacturer by BFAD is necessary, the cost of inspection shall be borne by the applicant establishment; 2.2.2.3 A description of the production process and quality control procedures to be followed by the contracted manufacturer, jointly certified by the owner and the pharmacist of the establishment.

2.2.3

Drug Distributors

2.2.3.1 Importers 2.2.3.1.1 Foreign Agency Agreement between the Philippine importer and foreign supplier duly authenticated by the territorial Philippine Consulate. 2.2.3.1.2 A certificate that the manufacturer of the raw material, active ingredient and/or finished product is registered in the country of origin, duly authenticated by the territorial Philippine Consulate, and evidence that the manufacturer meets BFAD standards for local manufacturers. If inspection of the foreign manufacturer is necessary, the cost of inspection shall be borne by the applicant establishment. 2.2.3.1.3 In case of finished products, Certificate of Free Sale of the products in the country of origin, duly authenticated by the territorial Philippine Consulate and evidence that such certificate is issued in substantial compliance with BFAD standards. 2.2.3.2 Exporters

2.2.3.2.1 A valid contract with BFAD-licensed manufacturer in addition to other requirements set by other competent authorities. 2.2.3.3 2.2.3.3.1 2.2.3.3.2 2.3 Wholesalers A valid contract with a BFAD licensed manufacturer, trader or distributor. A certification that the products it sells are registered with BFAD. Other Additional Requirements

In addition to the above standards and requirements, BFAD in the course of evaluating an application may require other additional documentation or evidence to satisfactorily ascertain the capability of the drug establishment. 3. Renewal of License To Operate (LTO)

3.1 The License To Operate shall have the following validities for all categories of drug establishments. 3.1.1 3.1.2 Initial Period (Initial Application) 1 year Subsequent Period (Renewal Application) 2 years

3.2 At least one month prior to the expiration of the LTO, drug establishments shall apply to renew their license.

3.3 In considering the renewal application, BFAD shall ascertain the continued compliance by the establishment with the standards and requirements stipulated in section 2.1 and 2.2. 3.4 3.4.1 3.4.2 The following grounds shall be basis for non-renewal of LTO: Failure to comply with BFAD standards and requirements. Serious, repeated or rampant violation of existing laws, rules and regulations.

3.4.3 Persistent shortcomings in demonstrating a capacity to perform in a manner that satisfactorily assures the safety, efficacy and quality of its drug products. 4. 4.1 Administrative Sanctions Grounds for Revocation of LTO

4.1.1 Misrepresentation of any material fact in the application for LTO and in any documentation used as basis for issuing the LTO. 4.1.2 For manufacturers and traders: any deficiency in GMP that is likely to result in adulterated, misbranded, substandard or unsafe products as determined by BFAD. This includes, among others, grossly inadequate premises, lack of key technical and professional personnel, lack of key equipment in production or quality control, poor or inadequate process control and inadequate or improper documentation of the production process. 4.1.3 4.1.4 4.1.5 For distributors: distribution of fake, misbranded, adulterated or unsafe drug products. Violation of BFAD standards of quality, efficacy, purity and safety of drug products. Sale or distribution of antibiotic products without batch certification by BFAD.

4.1.6 Failure to take adequate remedial or corrective measures for deficiencies identified in accordance with requirements of BFAD. 4.1.7 Failure to keep up to date, secure, orderly, and easily inspected records that would indicate continued compliance with standards. 4.2 Grounds for Suspension of LTO

4.2.1 Minor deficiencies in GMP or material management that need to be corrected but are not immediately or likely to result in adulterated, misbranded, substandard or unsafe products as determined by BFAD. This includes, among others, poor housekeeping, inadequate storage facilities, lack of minor equipment or requirement, and other minor shortcomings. 4.2.2. Lapses in record keeping of invoices, receipts or distribution records.

4.3

Re-application After Revocation

No establishment whose LTO was revoked may apply for an LTO within 5 years after the revocation of its license. 5. Schedule of Fees

5.1 Upon application for a license to operate as a drug establishment, the following nonrefundable fees shall be charged for each application: Renewal Initial (good for 2 years)

5.2 If a drug establishment engages in activities belonging to more than one of the above categories, applicant must apply for LTO for each of the category and pay the corresponding fees. 5.3 Only upon payment of application fees may the application be processed. A surcharge of fifty percent (50%) of the above fees shall be imposed on applications for renewal filed after the validity of the license has lapsed. Any change in the category of drug establishment or change in ownership shall require a new application. CHAPTER II Drug Outlets 1. Definitions of Different Types of Drug Outlets

1.1 Drugstore, Pharmacy or Botica, including Hospital Pharmacy/Dispensary means a drug outlet where registered drugs, chemical products, active principles, proprietary medicines or pharmaceutical specialties and dental, medicinal, galenical, or veterinary preparations are compounded and/or dispensed. 1.2 Retail outlet for non-prescription drugs including non- traditional outlets such as supermarkets and stores, means a drug outlet where registered non-prescription or over-thecounter (OTC) drugs are sold in their original packages, bottles or containers or in smaller quantities not in their original containers. 2. 2.1 Standards and Requirements for License To Operate (LTO) General Requirements

2.1.1 Applications any person desiring to operate or establish a drug establishment shall file with the BFAD an application supported by the following documents:

2.1.1.1 A standard petition form containing among others the name, age, citizenship and a passport size (5 x 5 cm) photo of the petitioner and other pertinent circumstances pertaining to the proposed drug establishment including the place where it is to be established. 2.1.1.2 Proof of registration as an establishment, i.e.:

(a) For single proprietorship, an authenticated photocopy of the Certificate of Business Name Registration issued by the Bureau of Domestic Trade (BDT) of the Department of Trade and Industry. (b) For partnership, corporations and other juridical persons; authenticated photocopies of the Certificate of Registration issued by Securities and Exchange Commission (SEC) and the Articles of Incorporation or Partnership. 2.1.1.3 A valid Certificate of Registration of the establishments Filipino pharmacist issued by the Professional Regulation Commission (PRC). 2.1.1.4 A Certification of Attendance to a BFAD-sponsored/accredited Seminar on Licensing of Drug Outlets. 2.1.1.5 (a) it. (b) An Affidavit of undertaking providing that the applicant shall: change the establishments name if there is already a validly registered name similar to

display the duly approved LTO in a conspicuous place within the establishment.

(c) notify BFAD in case of any change in the circumstances described in the application such as: change of location or change of pharmacist. 2.1.1.6 Tentative list of products intended to be sold using generic names with brand names when applicable. 2.1.1.7 An authenticated photocopy of Contract of Lease of the space to be occupied if the applicant does not own it. 2.2 Specific Requirements:

Any entity applying for a license to operate a drugstore, pharmacy or botica or retail outlet shall be required to demonstrate its capacity to perform adequately its functions to inform its clientele in accordance with Section 6(d) of R.A. 6675 and sell drugs and medicines, which are safe, effective, and of good quality to the public. It shall be required to conform with relevant standards and requirements specific for each category, in addition to the foregoing general requirements. 2.2.1 Drugstores, Pharmacy or Botica

2.2.1.1

Premises

2.2.1.1.1 A signboard in front of the place of business bearing the registered name of the drug store. For hospital pharmacy, the sign Pharmacy is sufficient. For drug outlet selling exclusively non-prescription or Over the Counter (OTC) drug product, the signboard should indicate so by putting the symbol non-Rx or its equivalent. 2.2.1.1.2 A well-ventilated area not less than 15 sq. m. in floor area with concrete, tile or wooden flooring. 2.2.1.1.3 A place suitable for compounding prescription and for washing and sterilizing bottles (compulsory only for hospital pharmacy). 2.2.1.1.4 A suitable and proper place for the adequate storage of drugs and biological products as specified on the label. 2.2.1.1.5 2.2.1.1.6 2.2.1.2 2.2.1.2.1 2.2.1.2.2 A suitable cabinet for keeping poisons and/or dangerous drugs. An adequate water supply. Reference Books and Documents Philippine National Drug Formulary (when available) United States Pharmacopeia/National Formulary (USP-NF) (latest edition).

2.2.1.2.3 R.A. 3720, otherwise known as the Foods, Drugs and Devices and Cosmetics Act as amended and relevant implementing rules and regulations. 2.2.1.2.4 regulations. 2.2.1.2.5 regulations. 2.2.1.2.6 2.2.1.2.7 2.2.1.3 2.2.1.3.1 2.2.1.3.2 2.2.1.3.3 R.A. 6675, Generics Act of 1988 and relevant implementing rules and

R.A. 5921 Pharmacy Law, as amended and relevant implementing rules and Remingtons Pharmaceutical Sciences (latest edition). Goodman & Gilman Pharmacological Basis of Therapeutics (latest edition). Record Books Duly Registered with the BFAD Prescription Book Dangerous Drug Book Exempt Preparation Book

2.2.1.3.4

Poisons Book

2.2.1.3.5 Record Book for Selected Non-Prescription Drugs, subject to abuse as determined by BFAD and/or Dangerous Drugs Board (DDB). 2.2.1.4 Utensils, Apparatus and Other Equipment

2.2.1.4.1 For all drugstores including hospital pharmacies, refrigerator for biologicals and other drug products needing refrigeration. 2.2.1.4.2 2.2.1.4.2.1 2.2.1.4.2.2 ml capacity. 2.2.1.4.2.3 For hospital pharmacy only: Prescription balance of one centigram sensitivity and a set of weights. Glass volumetric measures a set of not less than six pieces from 15 ml to 1000 Mortar and pestle a set of not less than three in assorted sizes.

2.2.1.5 A full-time validly registered pharmacist physically present while the drugstore is open to business. 2.2.1.6 Other Additional Requirements:

2.2.1.6.1 Invoices indicating the lot number or batch number of the manufacturers stock pursuant to BFAD Memo. Circular no. 001 s. 1983. 2.2.1.6.2 2.2.1.6.3 2.2.1.6.4 2.2.2 2.2.2.1 File of prescription filled, consecutively numbered. Dry Seal or Rubber Stamp containing the name and address of the drug outlet. Red and White labels indicating name and address of drugstore.

Requirements for a Retail Outlet for Non-Prescription Drugs Premises

2.2.2.1.1 A signboard in front of the place of business bearing the registered name of retail outlet and the symbol non-Rx or equivalent. 2.2.2.1.2 An adequate, well-ventilated area with concrete, tile, or wooden flooring.

2.2.2.1.3 A suitable and proper place for the adequate storage of non-prescription drugs. When there are products sold other than drugs, an area exclusively for drug products shall be allocated within the premises.

2.2.2.2 2.2.2.2.1 2.2.2.2.2 2.2.2.2.3 regulations; 2.2.2.2.4

Reference Books and Documents Philippine National Drug Formulary (when available); R.A. 5921, Pharmacy Law and its implementing rules and regulations; R.A. 6675, the Generics Act of 1988 and relevant implementing rules and

R.A. 3720 as amended or Foods, Drugs and Devices and Cosmetics Act;

2.2.2.3 Record Books as required by BFAD for selected non-prescription drugs subject to abuse as determined by BFAD and/or DDB 2.2.2.4 A full-time validly registered pharmacist physically present while the retail outlet is open for business. 2.2.2.5 Other Additional Requirements

2.2.2.5.1 Invoices indicating the lot number or batch number of the manufacturers stock pursuant to BFAD Memo. Circular No. 001 s. 1983. 2.2.2.5.2 3. Dry seal or Rubber Stamp containing the name and address of the drug outlet. Renewal of License to Operate (LTO)

In case of renewal of LTO the drug outlet must have a history of satisfactory performance, consistent with BFAD standards and requirements, without any case of serious violation of existing laws, rules and regulations. 4. 4.1 Administrative Sanctions Temporary Closure

Absence of pharmacist on three (3) inspections by BFAD inspector. 4.2 Suspension of License to Operate

4.2.1 Failure to produce invoices and receipts together with lot numbers, expiry dates for the drugs in stock. 4.2.2 4.2.3 4.3 Failure to properly record and keep a file of all prescriptions filled in the last two years. Refusal to allow entry of BFAD inspectors. Revocation of License to Operate

4.3.1 Sale or offer for sale of adulterated, misbranded, sub-standard, unregistered, expired and/or unsafe drugs or products marked Not for Sale. 4.3.2 4.3.3 Failure to properly record dangerous drugs as determined by DDB. Lack of pharmacist.

4.3.4 Failure to take necessary remedial or corrective measures within the prescribed period as directed by BFAD. 5. Validity

The license to operate shall have the following validities: Initial Period of validity Renewal Drugstore, Pharmacy or Botica Retail Outlet 6. Schedule of Fees 1 year 1 year 2 years 2 years Validity of Subsequent

Upon application for a license to operate as a drug outlet, the following non-refundable fees shall be charged for each application: Renewal Initial P500.00 per drugstore, pharmacy or botica outlet P200.00 per retail outlet carrying only OTC drugs P400.00 P1,000.00 (good for two years)

Only upon payment of application fees may the application be processed. A surcharge of fifty percent (50%) of the above fees shall be imposed on applications for renewal filed after the validity of the license has lapsed.

SEPARABILITY CLAUSE In case any provision of this rules and regulations is declared contrary to law or unconstitutional other provisions which are not affected thereby shall continue to be in force and in effect. REPEALING CLAUSE All administrative orders, rules and regulations and other administrative issuances or parts thereof, inconsistent with the provisions of this Regulation are hereby repealed or modified accordingly. EFFECTIVITY This Regulation shall take effect fifteen (15) days after its publication in a newspaper of general circulation. * * The foregoing Administrative Order was published in the Daily Globe issue of January 17, 1989. ANNEX A MINIMUM STANDARDS EQUIPMENT/MACHINES 1.0 1.1 1.1.1 1.1.2 1.2. 1.3. 1.4. 1.5. 2.0. 2.1. 2.1.1. FOR PHARMACEUTICAL MANUFACTURING

General Machinery and Equipment Weighing Scale 1 g. sensitivity 1 kg. sensitivity Labelling machine Coding machine Facility for washing and drying bottles Laboratory apparatus including measuring glasswares, chemical supplies, filter paper. Additional Machine and Equipment needed for each dosage form: Liquid/Suspension Stainless Steel tank with stirrer of appropriate capacity

2.1.2. 2.1.3. 2.1.4. 2.1.5. 2.1.6. 2.1.7. 2.1.8. 2.1.9. 2.2. 2.2.1. 2.2.2. 2.2.3. 2.2.4. 2.2.5. 2.2.6. 2.2.7. 2.2.8. 2.3 2.3.1. 2.3.2. 2.3.3. 2.3.4. 2.4.

Jacketed kettle Homogenizer Stainless steel pail, assorted sizes Deionizer or distilling apparatus Stainless steel storage tank 500 L Filter assembly Filling machine Pilfer-proof capper Tablet Mixer/blender Mill Granulator Drying Oven or fluidized-bed dryer Sifter/Sieves Tablet Press Dust collector/exhaust system Dehumidifier Capsule Mixer Dehumidifier Encapsulating machine Dust collector/exhaust system Powder/Granule Preparation

2.4.1. 2.4.2. 2.4.3. 2.4.4. 2.5. 2.5.1. 2.5.2. 2.5.3. 2.5.4. 2.5.5. 2.5.6. 2.6. 2.6.1 2.6.2 2.6.3 2.6.4 2.7. 2.7.1. 2.7.2. 2.7.3. 2.7.4. 2.7.5. 2.7.6.

Blender Powder filling machine Tamper-proof machine Dehumidifier Sterile products (Ophthalmic, etc.) Stainless steel tank with stirrer Stainless steel storage tank Membrane filter assembly Laminar flow system Filling machine Capping machine Ointment/Cream Mill Stainless tank with stirrer, jacketed Filling machine Crimper Small Volume Parenteral Products Vial washer/rinser Pyrogen-free distilling apparatus Storage tank s.s. Stainless steel tank with stirrer Membrane filter assembly Laminar flow system

2.7.7. 2.7.8. 2.7.9.

Ampule filter and sealer Vial filter and sealer/crimper Filling machine for liquid

2.7.10. Sterilizer/autoclave 2.7.11. Depyrogenating oven 2.8. 2.8.1. 2.8.2. 2.8.3. 2.8.4. 2.8.5. 2.8.6. 2.8.7. 2.8.8. 2.8.9. Large Volume Parenteral Products Water softener Carbon filter Deionizer Distilling unit Stainless steel tank with stirrer Stainless steel storage tank Membrane filter assembly Bottle/stopper washer Laminar flow assembly

2.8.10. Filter and sealer/crimper 2.8.11. Vacuum equipment 2.8.12. Autoclave/sterilizer 2.8.13. Depyrogenating oven 2.9. Penicillin Preparation

2.9.1. Separate areas, separate area and entrance from non-penicillin products. 2.9.2. Separate equipment outlay based on specific dosage form. 2.10. Optional equipment and Machine

2.10.1. Coating Pan 2.10.2. Mill

) for sugar coated tablet )

2.10.3. Polishing Pan

2.10.4. Sprayer for film coating 2.10.5. Sachet filler 2.10.6. Strip sealing machine 2.10.7. Blister pack machine 2.10.8. Tablet/capsule Counter ANNEX B MINIMUM STANDARDS FOR QUALITY CONTROL FACILITIES (DRUG MANUFACTURERS) 1.0. 1.1 1.1.1. 1.1.2. 1.1.3. 1.1.4. 1.1.5. 1.1.6. 1.1.7. 1.1.8. 1.1.9. GENERAL REQUIREMENTS Physico-Chemical Assay UV spectrophotometer Fluorphotometer (for vitamin preparation) Titrimeter Thin layer chromatography Analytical balance pH meter Drying oven Oven for stability testing Water bath

1.1.10. Magnetic stirrer 1.1.11. Mechanical shaker 1.1.12. Pycnometer 1.1.13. Desiccators/vacuum desiccators 1.1.14. Hot plate 1.1.15. Furnace 1.1.16. Glasswares 1.1.16.1. 1.1.16.2. 1.1.16.3. 1.1.16.4. 1.1.16.5. 1.1.16.6. 1.1.16.7. 1.1.16.8. 1.1.16.9. 1.1.16.10. 1.1.16.11. 1.1.16.12. Buret (4) Volumetric flask (6) Separatory funnel (3) Erlenmeyer flask (3) Beaker (assorted sizes, 2 pcs. of each size) Graduated cylinder (assorted sizes, 2 pcs. of each size) Pipette (6) Thermometer (2) Test Tube (24) Funnel (4) Stirring rod (6) Crucible (6)

Laboratory supplies/chemical/reagents/reference standards, etc. 1.2. 1.2.1. 1.2.1.1. Biological Assay Micro Assay Autoclave

1.2.1.2. 1.2.1.3. 1.2.1.4. 1.2.1.5. 1.2.1.6. 1.2.1.7. 1.2.1.8. 1.2.1.9.

Centrifuge Colony counter Incubator Refrigerator Bunsen burner Petri Dishes (24 pieces) Microscope Laboratory supplies/glasswares/chemicals/ culture/media etc.

1.2.2. Animal House and Laboratory Animals i.e. mice for safety test; rabbits for pyrogen test 1.3. 1.3.1. 1.3.2. 1.3.3. 1.3.4. 1.3.5. 1.3.6. 1.3.7. 1.4. Reference Books Latest United States Pharmacopeia/National Formulary British Pharmacopeia Latest Edition Remingtons Pharmaceutical Sciences Merck Index Drug Reference Manual BFAD Regulations/Pharmacy Laws Official Philippine National Drug Formulary Optional Requirements

NOTE: If product to be manufactured requires the use of any of the following then it becomes mandatory. 1.4.1. 1.4.2. 1.4.3. 1.4.4. Colorimeter Column Chromatography Gas-liquid chromatography Infrared spectrophotometer

1.4.5. 1.4.6. 1.4.7. 1.4.8. 1.4.9. 2.0. 2.1. 2.1.1. 2.1.2. 2.1.3. 2.1.4. 2.1.5. 2.1.6. 2.1.7. 2.1.8. 2.2. 2.2.1. 2.2.2. 2.2.3. 2.2.4. 2.3. 2.3.1. 2.3.2.

Polarimeter Polarograph High pressure liquid chromatography Ultra-sonic bath Kjeldahl assembly Additional Requirements based on dosage form to be manufactured Tablet Preparation Disintegration tester Dissolution rate assembly Friabilator Hardness tester Caliper Moisture balance Torsion balance/analytical balance Melting point apparatus Capsule Preparation Dissolution rate assembly Moisture balance Melting point apparatus Torsion balance/analytical balance Liquid/Suspension Viscosimeter Refractometer

2.3.3. 2.3.4. 2.4. 2.4.1. 2.4.2. 2.4.3. 2.5. 2.5.1. 2.5.2. 2.5.3. 2.5.4. 2.6. 2.6.1. 2.6.2. 2.7.

Visual inspection assembly pH meter Powder and Granules Moisture balance Torsion balance/analytical balance See 2.3 requirements for liquid/suspension Parenteral Visual Inspection system Leaker Test (Set-up) for ampules Pyrogen test Set-up Particle counter Ointment/Cream Viscosimeter pH meter Penicillin Preparation

2.7.1. Separate equipment from that of non-penicillin products depending on the dosage form to be manufactured. PURSUANT TO THE GENERICS ACT OF 1988 AND ITS IMPLEMENTING GUIDELINES, DOCTORS AND PHARMACISTS ARE URGED TO BEGIN GENERIC PRESCRIBING AND DISPENSING TODAY, JUNE 1, 1989 June 1 to August 31 is the designated learning and practice period for all medical, dental, veterinary and pharmaceutical professionals. Beginning September 1, the Generics Act of 1988 will be in full effect.

GUIDELINES ON PRESCRIBING MEDICINES BASED ON PRIOR LAWS * Only validly-registered medical, dental and veterinary practitioners, whether in private practice or employed in a private institution/corporation or in the government, are authorized to prescribe drugs. * All prescriptions must contain the name of the prescriber, office address, professional registration number, professional tax receipt number, patients/clients name, age and sex, and date of prescription. * For prohibited and regulated drugs, the following are required:

The prescriber must have an S-2 license. The special Dangerous Board prescription form must be used. A recording system following pertinent Dangerous Drugs Board regulations must be observed. ADDITIONAL GUIDELINES ON PRESCRIBING MEDICINES PURSUANT TO THE GENERICS ACT OF 1988 * Generic names shall be used in all prescriptions for:

Drugs with a single active ingredient, the generic name of the active ingredient shall be used in prescribing. Drugs with two or more active ingredients, the generic name of the active ingredients as determined by the Bureau of Food and Drugs shall be used in prescribing. * The generic name must be written in full but the salt or chemical form may be abbreviated. * The generic name of the drug ordered must be clearly written on the prescription immediately after the Rx symbol, or on the order chart. In addition to the generic name, a brand name may also be indicated. In such cases, the following shall be observed: * If written on a prescription pad, the brand name enclosed in parenthesis shall be written below the generic name.

* If written on a patients chart, the brand name enclosed in parenthesis shall be written after the generic name. * Only one drug product shall be prescribed on one prescription form.

* In prescribing drugs which need strict precaution in their use, the prescriber must comply with the following: After the Rx symbol but before the generic name he must write clearly (List B). Refer to attached appendix for details. The prescriber must ensure that the following information are accurately written on the prescription: * * * * mg. The generic name of the active ingredient(s) and the specific sat or chemical form. The manufacturer. The brand name, if so desired. The strength or dose level using units of the metric system. Example: 1 grain 60

* The delivery mode or delivery system: quick-dissolve, sustained release, etc., and the corresponding appropriate dose frequency or dose interval. VIOLATIVE, ERRONEOUS AND IMPOSSIBLE PRESCRIPTIONS Violative Prescription * * Where the generic name is not written. Where the generic name is not legible and a brand name which is legible is written.

* Where the brand name is indicated and instructions added (such as the phrase no substitution) which tend to obstruct, hinder or prevent proper generic dispensing. Violative prescription shall not be filled. They shall be kept and reported by the pharmacist of the drug outlet or any other interested party to the nearest Department of Health Office for appropriate action. The pharmacist shall advise the prescriber of the problem and/or instruct the customer to get the proper prescription. Erroneous Prescription

* * * *

Where the brand name precedes the generic name. Where the generic name is the one in parenthesis. Where the brand name is not in parenthesis. Where more than one drug product is prescribed on one prescription form.

Erroneous prescriptions shall not be filled. Such prescriptions shall also be kept and reported by the pharmacist of the drug outlet or any other interested party to the nearest Department of Health office for appropriate action. Impossible Prescriptions * * * * Drugs. When only the generic name is written but is not legible. When the generic name does not correspond to the brand name. When both the generic and the brand names are not legible. When the drug product prescribed is not registered with the Bureau of Food and

Impossible prescriptions shall not be filled. They shall be kept and reported by the pharmacist of the drug outlet or any other interested party to the nearest Department of Health office for appropriate action. The pharmacist shall advise the prescriber of the problem and/or instruct the customer to get the proper prescription. In cases of violative, erroneous and impossible prescriptions, the local Department of Health office shall be responsible for giving written notice to the erring doctor concerned and for transmitting through channels the report for violation/error to the Professional Regulation Commission or to the fiscals office for appropriate action. GUIDELINES ON DISPENSING OF MEDICINES BASED ON PRIOR LAWS * Ethical drugs can only be dispensed upon a written order of a validly-registered physician, dentist or veterinarian. * Non-prescription or over-the-counter drugs may be dispensed even without a written order of a validly-registered physician, dentist or veterinarian in duly licensed drug outlets. When dispensing over-the-counter drugs without a doctors prescription, the pharmacist shall give the necessary information and direction for use of the drug.

* All prescriptions dispensed in the drugstore, botica or hospital pharmacy shall be kept in file for two years and recorded in a prescription book duly registered with the Bureau of Food and Drugs which shall be opened for inspection to Food and Drugs Inspectors any time during business hours of the outlet. The prescription book shall be kept for two years after the last entry. ADDITIONAL GUIDELINES ON DISPENSING TO IMPLEMENT THE GENERICS ACT OF 1988 * All drug outlets are required to practice dispensing of drugs using generic names with some exceptions, modifications or qualifications in certain cases or circumstances prescribed herein. Drugstores, boticas, and other drug outlets. To ensure the informed choice and use of drugs by patient/buyer, the drug outlet is required to: * Inform the patient/buyer of all available drug products generically equivalent to the one prescribed with their corresponding prices. In so doing, the drug outlet shall not favor or suggest any particular product so that the patient/buyer may fully and adequately exercise his option to choose. * For this purpose, all drug outlets shall post in a conspicuous place in their respective establishments a list of drug products using generic names with their brand names, if any, and their corresponding current prices. A handbook or directory containing the above required information, readily accessible to the patient/buyer shall be considered substantial compliance. Hospital Pharmacies The following shall govern generic dispensing in hospital pharmacies, in the case of in-patients only: * Upon admission, the patient or his/her responsible relative shall indicate in writing whether he/she shall submit to the hospital drug policies or reserve the option to buy drugs and medicines outside of the hospital pharmacy. * Hospital pharmacies operating on an acceptable formulary system and pricing policy as determined by the Department of Health, and using generic terminology in procurement, prescribing, dispensing, and recording of drugs shall be exempted from the following: * Recording of prescription filled in the prescription book, provided such prescriptions shall be kept in file for two years. * Individually informing the in-patient/buyer on available generic equivalents and their corresponding prices. However, a handbook or directory containing the required drug information must be made available in the wards for patients, responsible relatives of patients and professional staff.

* In dispensing to the buyer, the drug products in the unit dose or products which are not in their original containers but transferred to small bottles, tin cans, boxes, plastic and/or paper envelopes and the like, the pharmacist shall place legibly on the required drug outlets label the following information: Name of patient Generic name of the drug Brand name, if any Manufacturer Dosage strength Expiry date Directions for use Name of Pharmacist

The partially-filled prescription shall be returned to the buyer after recording the partial filling in the prescription book. The drugstore which completes the filling of the prescription shall keep the prescription in file. Dispensing prohibited and Regulated Drugs (List) and Drugs Requiring Strict Precautions (List B) (Please see attached Lists) * In dispensing prohibited and regulated drugs requiring strict precautions in their use, the following shall be observed: Dispensing must be done by the pharmacist who shall affix his/her signature on the prescription filled. The order and instructions of the doctor as written on the prescription, must be precisely followed. Partial filling of prescription for prohibited and regulated drugs (List A) shall not be allowed. Guidelines on what to do with Violative, Erroneous, and Impossible Prescriptions * Violative and impossible prescriptions as defined in A.O. 62 (Generic Prescribing) shall not be filled. The pharmacist shall advise the prescriber of the problem and/or instruct the customer to get the proper prescription. These violative and impossible prescriptions shall be kept and reported by the pharmacist or other interested parties to the nearest Department of Health office for appropriate action. * Erroneous prescription shall be filled, but they shall also be kept and reported to the nearest Department of Health office for appropriate action. Violations on the part of Dispensers and Outlets

The following acts or omissions are considered violations of these rules and regulations: * Imposing a particular brand or product on the buyer.

* Inaccurate dispensing i.e. dispensing a drug product which does not meet the prescription as to any or all the following: active ingredient, dosage form and strength. * products. Failure to post or make accessible the required up-to-date information on drug

* Failure to indicate the generic name/official name designated by the Bureau of Food and Drugs and other required information on the drug outlets label of the dispensed drug. * Failure to record and keep prescriptions filled.

* Failure to report to the nearest Department of Health office cases of violative, erroneous, and/or wrong prescriptions within three months after receipt of such prescriptions.

Republic of the Philippines Congress of the Philippines Metro Manila Fourteenth Congress Second Regular Session

Begun and held in Metro Manila, on Monday, the twenty-eighth day of July, two thousand eight. Republic Act No. 9711 August 18, 2009

AN ACT STRENGTHENING AND RATIONALIZING THE REGULATORY CAPACITY OF THE BUREAU OF FOOD AND DRUGS (BFAD) BY ESTABLISHING ADEQUATE TESTING LABORATORIES AND FIELD OFFICES, UPGRADING ITS EQUIPMENT, AUGMENTING ITS HUMAN RESOURCE COMPLEMENT, GIVING AUTHORITY TO RETAIN ITS INCOME, RENAMING IT THE FOOD AND DRUG ADMINISTRATION (FDA), AMENDING CERTAIN SECTIONS OF REPUBLIC ACT NO. 3720, AS AMENDED, AND APPROPRIATING FUNDS THEREOF Be it enacted by the Senate and House of Representatives of the Philippines in Congress assembled::

Section 1. The Bureau of Food and Drugs (BFAD) is hereby renamed the Food and Drug Administration (FDA). Section 2. This Act shall be known as the "Food and Drug Administration (FDA) Act of 2009". Section 3. It is hereby declared a policy of the State to adopt, support, establish, institutionalize, improve and maintain structures, processes, mechanisms and initiatives that are aimed, directed and designed to: (a) protect and promote the right to health of the Filipino people; and (b) help establish and maintain an effective health products regulatory system and undertake appropriate health manpower development and research, responsive to the country's health needs and problems. Pursuant to this policy, the State must enhance its regulatory capacity and strengthen its capability with regard to the inspection, licensing and monitoring of establishments, and the registration and monitoring of health products. Section 4. This Act has the following objectives: (a) To enhance and strengthen the administrative and technical capacity of the FDA in the regulation of establishments and products under its jurisdiction; (b) To ensure the FDA's monitoring and regulatory coverage over establishments and products under its jurisdiction; and (c) To provide coherence in the FDA's regulatory system for establishments and products under its jurisdiction. Section 5. Section 4 of Republic Act No. 3720, as amended, is hereby further amended to read as follows: "SEC. 4. To carry out the provisions of this Act, there is hereby created an office to be called the Food and Drug Administration (FDA) in the Department of Health (DOH). Said Administration shall be under the Office of the Secretary and shall have the following functions, powers and duties: "(a) To administer the effective implementation of this Act and of the rules and regulations issued pursuant to the same; "(b) To assume primary jurisdiction in the collection of samples of health products; "(c) To analyze and inspect health products in connection with the implementation of this Act; "(d) To establish analytical data to serve as basis for the preparation of health products standards, and to recommend standards of identity, purity, safety, efficacy, quality and fill of container; "(e) To issue certificates of compliance with technical requirements to serve as basis for the issuance of appropriate authorization and spot-check for compliance with regulations regarding operation of manufacturers, importers, exporters, distributors, wholesalers, drug outlets, and other establishments and facilities of health products, as determined by the FDA; "x x x "(h) To conduct appropriate tests on all applicable health products prior to the issuance of appropriate

authorizations to ensure safety, efficacy, purity, and quality; "(i) To require all manufacturers, traders, distributors, importers, exporters, wholesalers, retailers, consumers, and non-consumer users of health products to report to the FDA any incident that reasonably indicates that said product has caused or contributed to the death, serious illness or serious injury to a consumer, a patient, or any person; "(j) To issue cease and desist orders motu propio or upon verified complaint for health produts, whether or not registered with the FDA Provided, That for registered health products, the cease and desist order is valid for thirty (30) days and may be extended for sixty (60) days only after due process has been observed; "(k) After due process, to order the ban, recall, and/or withdrawal of any health product found to have caused the death, serious illness or serious injury to a consumer or patient, or is found to be imminently injurious, unsafe, dangerous, or grossly deceptive, and to require all concerned to implement the risk management plan which is a requirement for the issuance of the appropriate authorization; "(l) To strengthen the post market surveillance system in monitoring health products as defined in this Act and incidents of adverse events involving such products; "(m) To develop and issue standards and appropriate authorizations that would cover establishments, facilities and health products; "(n) To conduct, supervise, monitor and audit research studies on health and safety issues of health products undertaken by entities duly approved by the FDA; "(o) To prescribe standards, guidelines, and regulations with respect to information, advertisements and other marketing instruments and promotion, sponsorship, and other marketing activities about the health products as covered in this Act; "(p) To maintain bonded warehouses and/or establish the same, whenever necessary or appropriate, as determined by the director-general for confiscated goods in strategic areas of the country especially at major ports of entry; and "(q) To exercise such other powers and perform such other functions a8 may be necessary to carry out its duties and responsibilities under this Act." Section 6. Section 5 of Republic Act No. 3720, as amended, is hereby further amended and new subsections are added to read as follows: "SEC. 5. The FDA shall have the following centers and offices: "(a) The Centers shall be established per major product category that is regulated, namely: "(1) Center for Drug Regulation and Research (to include veterinary medicine, vaccines and biologicals);

"(2) Center for Food Regulation and Research; "(3) Center for Cosmetics Regulation and Research (to include household hazardous/urban substances); and "(4) Center for Device Regulation, Radiation Health, and Research. "These Centers shall regulate the manufacture, importation, exportation, distribution, sale, offer for sale, transfer, promotion, advertisement, sponsorship of, and/or, where appropriate, the use and testing of health products. The Centers shall likewise conduct research on the safety, efficacy, and quality of health products, and to institute standards for the same. "(b) Each Center shall be headed by a director. The Centers shall be so organized such that each will have, at least, the following divisions: "(1) Licensing and Registration Division, which shall be responsible for evaluating health products and establishments as covered by this Act for the purpose of issuance of authorizations and conditions to be observed; "(2) Product Research and Standards Development Division, which shall be responsible for the conduct of research, development of standards and regulations, compliance monitoring, and the oversight and audit of related researches that would ensure safety, quality, purity and efficacy of health products, as covered in this Act; and "(3) Laboratory Support Division, which shall be responsible for the conduct of research and appropriate testa and calibration, analyses and trials of products including, but not limited to, assays, and the conduct of oversight and/or audit of centers conducting bioavailability and bioequivalence tests and other tests as covered by this Act. It shall likewise provide direct line support to the centers which shall be separate and distinct per major product category that is regulated. "(c) The Administration and Finance Office headed by the deputy director-general for administration and finance shall have, at least, the following divisions: the Human Resource Development Division; Property and Logistics Management Division; Human Resource Management Division; Assets and Financial Management Division; and the Information and Communication Technology Management Division. "(d) The Policy and Planning Office which shall be under the Office of the Director-General shall have, at least, a training, advocacy and communications division and shall monitor the performance of the centers for product research and evaluation and standards development. "(e) The Field Regulatory Operations Office headed by the deputy director-general for field regulatory operations shall include, among others, all the field offices, field or satellite laboratories and the regulatory enforcement units. "(f) The Legal Services Support Center shall provide legal services to the entire FDA and shall be directly under the Office of the Director-General."

Section 7. Section 6 of Republic Act No. 3720, as amended, is hereby further amended, to read as follows: "(a) The FDA shall be headed by a director-general, with the rank of undersecretary, who shall be tasked, among others, to determine the needed personnel and to appoint personnel, below the assistant director level in coordination with the Secretary of Health. "(b) The director-general shall be assisted by two (2) deputy directors-general, one for administration and finance and another for field regulatory operations. "(c) The director-general and deputy directors-general shall be appointed by the President of the Republic of the Philippines. "(d) The director-general shall, referably, possess either a university degree in medicine or at least the relevant master's degree in pharmaceutical sciences or allied sciences, or equivalent executive course in any regulatory management. In addition, he/she shall have management experience in his/her field of discipline or profession and in any development, manufacturing, regulatory work or quality assurance of products as covered in this Act. "(e) The Deputy Director-General for Field Regulatory Operations of the FDA shall, preferably, possess the relevant master's degree in pharmaceutical sciences or allied sciences, or equivalent executive course in any regulatory management. In addition, he/she shall have management experience in his/her field of discipline or profession and in any development, manufacturing, regulatoly work or quality assurance of products as covered in this Act. "(f) The Deputy Director-General for Administration and Finance of the FDA shall he a certified public accountant or shall possess a master's degree in accounting, management, economics or any business course, and must have management experience in a position related to his/her field of discipline or profession. "(g) A person who was previously employed in a regular full-time capacity regardless of its consultative designation at higher management supervisory levels in regulated establishments, including related foundations, shall be disqualified from appointment as director-general and deputy director-general within three (3) years from termination of employment with the said establishment or foundation. All persons who are candidates for appointment as director-general and deputy director-general must disclose all their incomes for the past three (3) years from all establishments regulated by this Act. The director-general and the two (2) deputy directors-gencral shall, upon assumption into office, declare any conflict of interest with any establishment covered by the FDA, including their foundiitions. "(h) Each center and field office shall be headed by a director director who shall be assisted by an assistant director. These directors shall be appointed by the Secretary of Health. "(i) The existing directors of the Bureau of Health Devices and Technology (BHDT) and division chiefs of the BFAD shall be given preference for appointment as directors and assistant directors of their respective centers: Provided, That if the current officers of the BFAD and the BHDT applying for the above positions lack the required third level civil service eligibility, they will have to comply with the said requirement within three (3) yearn from their appointment, otherwise their appointment shall be revoked immediately."

Section 8. Section 7 of Republic Act No. 3720, as amended, is hereby further amended to read as follows: "The FDA shall review its staffing pattern and position titles subject to the approval of the Secretary of Health." Section 9. Section 10, subsections (a), (e), (f), (g), (h), (i), (q),(r), (v), and (w) of Republic Act No. 3720, as amended, are hereby further amended, and new subsections (x), (y), (z), (aa), (bb), (cc), (dd), (ee), (ff), (gg), (hh), (ii), (jj), (kk), (ll), and (mm) are hereby added to read as follows: "SEC. 10. For the purposes of this Act, the term: "(a) 'FDA' means the Food and Drug Administration. "x x x "(e) 'Food' means any processed substance which is intended for human consumption and includes drink for man, beverages, chewing gum and any substances which have been used as an ingredient in the manufacture, preparation or treatment of food. "(f) 'Drug' means: (1) articles recognized in official pharmacopeias and formularies, including official homeopathic pharmacopeias, or any documentary supplement to any of them, which are recognized and adopted by the FDA; (2) articles intended for use in the diagnosis, cure, mitigation, treatment, or prevention of disease in man or other animals; (3) articles (other than food) intended to affect the structure of any function of the body of humans or animals; or (4)articles intended for use as a component of any articles specified in clauses (1), (2), or (3) but do not include devices or their components, parts or accessories. "(g) 'Device' means medical devices, radiation devices and health-related devices. "(1) 'Medical device' means any instrument, apparatus, implement, machine, appliance, implant, invitro reagent or calibrator, software, material, or other similar or related article intended by the manufacturer to be used alone, or in combination, for human beings for one or more of the specific purpose(s) of: diagnosis, prevention,, monitoring, treatment or alleviation of disease; diagnosis, monitoring, treatment, alleviation of, or compensation for an injury; investigation, replacement, modification, or support of the anatomy or of a physiological process; supporting or sustaining life; preventing infection; control of conception; disinfection of medical devices; and providing information for medical or diagnostic purposes by means of in-vitro examination of specimens derived from the human body. This device does not achieve its primary intended action in or on the human body by pharmacological, immunological, or metabolic means but which may be assisted in its intended function by such means. "(2) 'Radiation device' means an electrical or electronic apparatus emitting any ionizing or nonionizing electromagnetic or particulate radiation; or any sonic; infrasonic, or ultrasonic wave. It includes ionizing radiation emitting equipment which is not intentionally designed to produce radioactive materials. "(3) 'Health-related device' means any device not used in health care but has been determined by the

FDA to adversely affect the health of the people. "(h) 'Cosmetics' means any substance or preparation intended to be placed in contact with the various external parts of the human body or with the teeth and the mucous membranes of the oral cavity, with a view exclusively or mainly to cleaning them, perfuming them, changing their appearance and/or correcting body odor, and/or protecting the body or keeping them in good condition. "(i) 'Label' means a display of written, printed, or graphic matter upon, the immediate container of any article and a requirement made by or under authority of this Act that any word, statement, or other information appearing on the label shall not be considered to be complied with unless such word, statement, or other information also appears on the outside container or wrapper, if any there be, of the retail package of such article, or easily legible through the outside container or wrapper. "x x x "(q) 'Director-general' means the head of the FDA. "(r) 'Distribute' means the delivery or sale of any health product for purposes of distribution in commerce, except that such term does not include the manufacture or retail of such product. "x x x "(v) 'Manufacturer', in relation to a health product, means an establishment engaged in any and all operations involved in the production of health products including preparation, processing, compounding, formnlating, filling, packing, repacking, altering, ornamenting, finishing and labeling with the end in view of its storage, sale or distribution: Provided, That the term shall not apply to the compounding and filling of prescriptions in drugstores and hospital pharmacies. A trader shall be categorized as a manufacturer. "(w) 'Veterinary drugs' means drugs intended for use for animals including any drug intended for use in animal feeds but not including animal feeds within the contemplation of the implementing rules and regulations. "(x) 'Assay' is an analysis to determine the (1) presence of a substance and the amount of that substance, or (2) the pharmaceutical potency of a drug. "(y) 'Authorization' means a permission embodied in a document granted by the FDA to a natural or juridical person who has submitted an application to implement the manufacture, importation, exportation, sale, offer for sale, distribution, transfer, and/or, where appropriate, the use, testing, promotion, advertising, or sponsorship of health products. The authorization can take the form of a permit, a license, a certificate of registration, of accreditation, of compliance, or of exemption, or any similar document. "(z) 'Bioavailability' means the rate and extent to which the active ingredient or therapeutic ingredient is absorbed from a drug and becomes available at the site of drug action. "(aa) 'Bioequivalence' means the rate and extent of absorption to which the drugs do not show a significant difference from the rate and extent of the listed drug when administered at the same molar dose of the

therapeutic ingredient under similar experimental conditions in either a single dose or multiple doses. Bioequivalence shall also refer to the absence of a signiticant difference on the rate and extent-to-which the active ingredient(s) of the sample and reference drug becomes available at the site of drug action when administered under the same molar dose and under similar conditions. "(bb) 'Distributor/importer/exporter' means any establishment that imports or exports raw materials, active ingredients and/or finished products for its own use or for wholesale distribution to other establishments or outlets. If the distributor/importer/exporter sells to the general public, it shall be considered a retailer. "(cc) 'Distributor/wholesaler' means any establishment that procures raw materials, active ingredients and/or finished products from local establishments for local distribution on wholesale basis. "(dd) 'Establishment' means a sole proprietorship, a partnership, a corporation, an institution, an association, or an organization engaged in the manufacture, importation, exportation, sale, offer for sale, distribution, donation, transfer, use, testing, promotion, advertising, or sponsorship of health products including the facilities and installations needed for its activities. "(ee) 'Food/dietary supplement' means a processed food product intended to supplement the diet that bears or contains one or more of the following dietary ingredients: vitamin, mineral, herb, or other botanical, amino acid, and dietary substance to increase the total daily intake in amounts conforming to the latest Philippine recommended energy and nutrient intakes or internationally agreed minimum daily requirements. It usually is in the form of capsules, tablets, liquids, gels, powders or pills and not represented for use as a conventional food or as the sole item of a meal or diet or replacement of drugs and medicines. "(ff) 'Health products' means food, drugs, cosmetics, devices, biologicals, vaccines, in-vitro diagnostic reagents and household/urban hazardous substances and/or a combination of and/or a derivative thereof. It shall also refer to products that may have an effect on health which require regulations as determined by the FDA. "(gg) 'Household/urban hazardous substance' is: "(1) Any substance or mixture of substances intended for individual or limited purposes and which is toxic, corrosive, an irritant, a strong sensitizer, is flammable or combustible, or generates pressure through decomposition, heat or other means, if such substance or mixture of substances may cause substantial injury or substantial illness during or as a proximate result of any customary or reasonably foreseeable ingestion by children, but shall not include agricultural fertilizer, pesticide, and insecticide, and other economic poisons, radioactive substance, or substances intended for use as fuels, coolants, refrigerants and the like; "(2) Any substance which the FDA finds to be under the categories enumerated in clause (1) of this paragraph; "(3) Any toy or other articles intended for use by children which the FDA may determine to pose an electrical, chemical, physical, or thermal hazard; and "(4) This term shall not apply to food, drugs, cosmetics, devices, or to substances intended for use as

fuels when stored in containers and used in the heating, cooking or refrigeration system of a house, but such term shall apply to any article which is not in itself an agricultural pesticide but which is a hazardous substance, as construed in paragraph (1) of this section, by reason of bearing or containing such harmful substances described therein. "(hh) 'In-vitro diagnostic reagents' are reagents and systems intended for use in the diagnosis of disease or other conditions, including a determination of the state of health, in order to cure, mitigate, treat or prevent disease or its sequelae. "(ii) 'Licensing' means the process of approval of an application to operate or establish an establishment prior to engaging in the manufacture, importation, exportation, sale, offer for sale, distribution, transfer, and where applicable the use, testing, promotion, advertisement, and/or sponsorship of health products. "(jj) 'Misbranding' means, in addition to definitions in existing laws, misinformation or misleading information on the label or other information materials authorized by the FDA. It shall not refer to copyright, trademark, or other intellectual property-like instruments. "(kk) 'Registration' means the process of approval of an application to register health products prior to engaging in the manufacture, importation, exportation, sale, offer for sale, distribution, transfer, and where applicable, the use, testing, promotion, advertisement, and/or sponsorship of health products. "(ll) 'Trader' means any establishment which is a registered owner of a health product and procures the raw materials and packing components and provides the production monographs, quality control standards and procedures, but subcontract the manufacture of such product to a licensed manufacturer. In addition, a trader may also engage in the distribution and/or marketing of its products. "(mm) 'Retailer' means any establishment which sells or offers to sell any health product directly to the general public." Section 10. Section 11, subsections (a), (b), (d), (g), (j),(k) and (l) of Republic Act No. 3720, as amended, are hereby further amended to read as follows: "SEC. 11. The following acts and the causing thereof are hereby prohibited: "(a) The manufacture, importation, exportation, sale, offering for sale, distribution, transfer, non-consumer use, promotion, advertising, or sponsorship of any health product that is adulterated, unregistered or misbranded. "(b) The adulteration or misbranding of any health product. "x x x "(d) The giving of a guaranty or undertaking referred to in Section twelve (b) hereof which guaranty or undertaking is false, except by a person who relied upon a guaranty or undertaking to the same effect, signed by, and containing the name and address of the person or entity from whom he received in good faith the health products or the giving of a guaranty or undertaking referred to in Section twelve (b) which guaranty or

undertaking is false. "x x x "(g) The alteration, mutilation, destruction, obliteration, or removal of the whole or any part of the labeling of, or the doing of any other act with respect to health products if such act is done while such article is held for sale (whether or not the first sale) and results in such article being adulterated or misbranded Provided, That a retailer may sell in smaller quantities, subject to guidelines issued by the FDA. "x x x "(j) The manufacture, importation, exportation, sale, offering for sale, distribution, transfer, non-consumer use, promotion, advertisement, or sponsorship of any health product which, although requiring registration, is not registered. with the FDA pursuant to this Act. "(k) The manufacture, importation, exportation, sale, offering for sale, distribution, transfer, or retail of any drug, device or in-vitro diagnostic reagent; the manufacture, importation, exportation, transfer or distribution of any food, cosmetic or household/urban hazardous substance; or the operation of a radiation or pest control establishment by any natural or juridical person without the license to operate from the FDA required under this Act. "(l) The sale, offering for sale, importation, exportation, distribution or transfer of any health product beyond its expiration or expiry date, if applicable. "x x x "The prohibited acts mentioned herein shall cover all applicable health products." Section 11. Section 12, subsection (a) of Republic Act No, 3720, as amended, is hereby further amended to read as follows: "SEC. 12. (a) Any person who violates any of the provisions of Section eleven hereof shall, upon conviction, suffer the penalty of imprisonment ranging from one (1) year but not more than ten (10) years or a fine of not less than Fifty thousand pesos (P50,000.00) but not more than Five hundred thousand pesos (P500,000.00), or both, at the discretion of the court: Provided, That if the offender is a manufacturer, importer or distributor of any health product, the penalty of at least five (5) years imprisonment but not more than ten (10) years and a fine of at least Five hundred thousand pesos (P500,000.00) but not more than Five million pesos (P5,000,000.00) shall be imposed Provided, further, That an additional fine of one percent (1%) of the economic value/cost of the violative product or violation, or One thousand pesos (P1,000.00), whichever is higher, shall be imposed for each day of continuing violation: Provided, finally, That health products found in violation of the provisions of this Act and other relevant laws, rules and regulations may be seized and held in custody pending proceedings, without hearing or court order, when the director-general has reasonable cause to believe from facts found by him/her or an authorized officer or employee of the FDA that such health products may cause injury or prejudice to the consuming public. "x x x

"Should the offense be committed by a juridical person, the Chairman of the Board of Directors, the president, general manager, or the partners and/or the persons directly responsible therefore shall he penalized. "Should the offense be committed by a foreign national, he/she shall, in addition to the penalties prescribed, be deported without further proceedings after service of sentence. "x x x." Section 12. Section 26, subsections (c) and (d) of Republic Act No. 3720, as amended, are hereby further amended and subsection (g) is hereby added thereto to read as follows: "x x x "(c) Hearings authorized or required by this Act shall be conducted by the FDA. "(d) Upon preliminary findings of the conduct of prohibited act/s, the director-general shall issue the proper notices or orders to the person or persons concerned and such person or persons shall be given an opportunity to be heard before the FDA. "x x x "(g) Both criminal and administrative actions may be instituted separately and independent of one another." Section 13. Section 29-A of Republic Act No. 3720, as amended, is hereby further amended, and new subsections are added to read as follows: "SEC. 29-A. Administrative Sanctions. - Where there is finding of prohibited actions and determination of the persons liable thereto, after notice and hearing, the director-general is empowered to impose one or more of the following administrative penalties: "(1) Cancellation of any authorization which may have been granted by the FDA, or suspension of the validity thereof for such period of time as the director-general may deem reasonable which shall not exceed one (1) year: "(2) A fine of not less than Fifty thousand pesos (P50,000.00) but not more than Five hundred thousand pesos (P500,000.00). An additional fine of not more than One thousand pesos (P1,000.00) shall be imposed for each day of continuing violation; and "(3) Destruction and/or appropriate disposition of the subject health product, and/or closure of the establishment for any violation of this Act, as determined by the director-general." Section 14. A new Section 30 and a new headnote "Additional Powers and Functions of the Director-General" are hereby added to Republic Act No. 3720, which shall read as follows:

"SEC. 30. The Director-General shall also exercise the following powers: "(1) To hold in direct or indirect contempt any person who disregards orders or writs he or she issues and impose the appropriate penalties following the same procedures and penalties provided in the Rules of Court; "(2) To administer oaths and affirmations and issue subpoena duces tecum and subpoena ad testificandum requiring the production of such books, contracts, correspondence, records, statement of accounts and other documents and/or the attendance and testimony of parties and witnesses as may be material to the investigation conducted by the FDA; "(3) To obtain information from any officer or office of the national or local governments, government agencies and its instrumentalities; "(4) To issue orders of seizure, to seize and hold in custody any article or articles of food, device, cosmetics, household hazardous substances and health products that is adulterated, counterfeited, misbranded or unregistered, or drug, in-vitro diagnostic reagent, biologicals, and vaccine that is adulterated or misbranded, when introduced into domestic commerce pending the authorized hearing under Republic Act No. 3720, as amended, Executive Order No. 175 (1987), and Republic Act No. 7394, otherwise known as the Consumers Act of the Philippines; "(5) To call on the assistance of any department, office or agency and deputize members of the Philippine National Police or any law enforcement agency for the effective implementation of this Act; and "(6) To exercise such powers and functions as may be necessary for the effective implementation of this Act." Section 15. Two new sections shall be added, which shall be the new Sections 31 and 32 of Republic Act No. 3720, as amended, which shall read as follows: "SEC. 31. The orders, rulings or decisions of the FDA shall become final and executory fifteen (15) days after the receipt of a copy thereof by the party adversely affected unless within that period, an administrative appeal has been perfected. One motion for reconsideration may be filled, which shall suspend the running of the said period." "SEC. 32. The orders, rulings or decisions of the FDA shall be appealable to the Secretary of Health. An appeal shall be deemed perfected upon filing of the notice of appeal and posting of the corresponding appeal bond. "An appeal shall not stay the decision appealed from unless an order from the Secretary of Health is issued to stay the execution thereof." Section 16. Section 30 of Republic Act No. 3720, as amended, shall be renumbered as Section 33, and the subsequent sections shall also be renumbered accordingly. Section 17. Section 31, Chapter XIII of Republic Act No. 3720, as amended, is hereby further amended to read as follows:

"SEC. 34. Fees and Other Income. "(a) Upon the sole approval of the Secretary, the authorization and other fees shall annually be determined and reviewed by the FDA and any proposed increase shall be published in two (2) leading newspapers of general circulation. "(b) There shall be determined and constituted additional fees such as sale of publications and services, assessment fees, fines, penalties, and other fees and charges outside the usual licensing and registration fees, to be known as 'other related regulatory fees'. "(c) The Director-General of the FDA, upon approval of the Secretary, shall be authorized to promulgate rules and regulations governing the collection of the 'other related regulatory fees'. Upon approval of the Secretary, these fees shall likewise be reviewed periodically and any proposed increase shall be published in two (2) leading newspapers of general circulation." Section 18. All income that the FDA is allowed to retain under Section 31 of the Universally Accessible Cheaper and Quality Medicines Act of 2008 shall, any provision of law to the contrary notwithstanding, be deposited in an authorized government depository bank as a special regulatory fund. Any interest earned by such fund shall form part of the retained income. Such fund shall be used primarily for the acquisition of office and laboratory space, human resource development and expansion, purchase of laboratory equipment and motor vehicles, the upgrading of its current facilities and equipment and maintenance, other operating expenses ofthe central office laboratory divisions and satellite laboratories in Davao, Cebu and other testing laboratories, in case the above laboratories will be increased, and other activities or services of the agency in the performance of its mandate. The fund shall be allowed to accept grants, donations and all other endowments from local and external sources in accordance with pertinent laws, rules and regulations. The retention, use and application of this fund shall not be delayed, amended, altered or modified, or affected in any way by an order or directive from any executive office, but will be subject only to the general accounting rules and guidelines by the Commission on Audit (COA). The primary purpose of the fund as herein stated shall prevail over any other purpose that may be pursued by the FDA on its own initiative or through an order or directive by any higher office. The FDA shall submit to the Secretary of Health, the Secretary of Budget and Management and the Congressional Oversight Committee, created under Section 23 of this Act, a report on how the funds were utilized, including its accomplishments. There shall also be established a legal fund out of the interest earned from the retained income for use in case of legal actions against the officials and employees of the FDA in the course of the exercise of their official functions and duties. Section 19. The FDA shall establish a Regulatory Enforcement Unit (REU) for a period not exceeding five (5) years from the effectivity of this Act. It shall be composed of at least five (5) qualified personnel in every region who shall be directly under the control and supervision of the Deputy Director-General for Field Regulatory Operations and shall be administratively supported by the field offices. They shall: (a) Bear arms, wear official uniforms and insignias and shall be classified as law enforcement agents; (b) Serve and execute rulings, orders, and decisions of the Director-General of the FDA; and

(c) Execute and serve search warrants and arrest warrants issued by the courts in connection with violations under this Act and related laws concerning the regulation of health products. All law enforcement agents shall undergo the appropriate training to equip them with the necessary skills needed for this purpose. Their authority and functions shall be strictly limited to the implementation of the FDA's regulatory functions. All regional regulatory enforcement units shall be headed by a lawyer who is at least thirty (30) years old but not older than fifty (50), an Integrated Bar of the Philippines (IBP) member of good standing, and shall have a rank of a Division Director; and an assistant who must be at the very least a law graduate who shall have a rank of an Assistant Division Director. Section 20. A new chapter XIV and three new sections, Sections 35, 36, and 37 shall be introduced, which shall read as follows: "CHAPTER XIV "TESTING LABORATORIES AND FIELD OFFICES "SEC. 35. The FDA is hereby mandated to improve, upgrade and increase the capability of the agency, to test, calibrate, assay and examine samples of health products. For the purpose of achieving the above mandate, there shall be established at least one (1) testing laboratory each in Luzon, Visayas and Mindanao, which shall have the necessary and appropriate state-of-the-art laboratory equipment and personnel complement. The main testing laboratories at the central office shall be maintained and shall serve as a support unit to the centers for product research and evaluation and standards development and shall serve as testing centers that would include assay and the conduct, supervision, oversight and/or audit of bioequivalence and bioavailability test/researches, among others. The existing laboratories in Cebu and Davao will be upgraded and transformed as quality assurance laboratories, while another one will be established in Subic, Zambales. "The testing laboratories may be increased by the director-general, upon approval of the Secretary. Moreover, the director-general, upon approval of the Secretary, may call upon other government and private testing laboratories to conduct testing, calibration, assay and examination of samples of health products: Provided, That the private testing laboratories are accredited by the Philippine Accreditation Office (PAO) of the Department of Trade and industry (DTI) and the DOH." "SEC. 36. The FDA shall establish field offices in all regions of the country to effectively implement its regulatory functions. The current regional food and drug regulatory officers and regional health physicists in every regional office of the DOH shall now be put under the FDA's sole control and supervision. The regional field office shall also assume primary jurisdiction in the collection of samples of food, drugs, devices and cosmetics being imported or offered for import at a port of entry other than Manila in his/her assigned region and where it appears that said items or products satisfy any of the conditions as provided for in Section 33(a) of Republic Act No. 3720, as amended, without prejudice to the exercise of the powers of the directorgeneral provided under Sections 13 and 14 of this Act in the exercise of the agency's regulatory functions. The field offices shall be comprised of the following: (a) licensing, inspection and compliance division, which shall have charge of the inspection of food, drugs and cosmetic establishments engaged in their manufacture, importation, distribution, and sale; (b) satellite laboratory division; and (c) administrative division."

"SEC. 37. The FDA, with the approval of the Secretary, shall create organizational units which are deemed necessary to address emerging concerns and to be abreast with internationally acceptable standards. There shall be created additional plantilla positions to augment the human resource complement of the FDA, subject to existing rules and regulations." Section 21. Appropriations. - The appropriations for the BFAD and the BHDT included in the budget of the DOH under the current General Appropriations Act shall be used to carry out the implementation of this Act. The appropriation may be augmented by the income which the agency is authorized to use under this Act. Thereafter, such sums as may be necessary for its continued implementation shall be included in the annual General Appropriations Act. Section 22. Implementing Rules and Regulatiorts. - The DOH shall promulgate, in consultation with the FDA, the implementing rules and regulations of this Act within one hundred twenty (120) days after the passage of this Act. Section 23. Congressional Oversight Committee. - A Congressional Oversight Committee (COC) is hereby created composed of the Chairpersons of the Committees on Health and Appropriations of the House of Representatives and two (2) Members to be appointed by the Speaker, the Chairpersons of the Committees on Health and Finance of the Senate and two (2) Members to he appointed by the President of the Senate, to oversee the implementation of this Act for a period of five (5) years and to review the accomplishments and the utilization of income of the FDA. The secretariat of the COC shall be drawn from the existing personnel of the committees comprising the COC. Section 24. Transitory Provisions. - The BFAD Director and Deputy Director shall serve as FDA Director-General and Deputy Director-General for Field Regulatory Operations, respectively. The current officials and employees of the BFAD shall be transferred as far as practicable to the appropriate unit in the FDA as determined by the Director-General. The current officials and employees of the BHDT shall be transferred to the Center for Device Regulation, Radiation Health, and Research. The current regional food and drug regulatory officers and regional health physicists under the Centers for Health Development of the DOH shall be transferred as far as practicable to the appropriate unit in the FDA as determined by the Director-General. There shall be no demotion in ranks and positions and no diminution in salaries. benefits, allowances and emoluments of all BFAD, BHDT and indicated Center for Health and Development (CHD) personnel transferred to the FDA. All positions, powers, functions and duties together with the facilities, equipment, supplies, records, files, appropriations, and funds for these bureaus and the indicated CHD personnel shall be transferred to the FDA. Section 25. Coverage. - This Act shall govern all health products: Provided, That nothing in this Act shall be deemed to modify the sole and exclusive jurisdiction of other specialized agencies and special laws only insofar as the acts covered by these specialized agencies and laws, including, but not limited to, those covered by Republic Act No. 9211, Executive Order No. 245, Executive Order No. 18, and Presidential Decree No. 1468. Section 26. Separability Clause. - If any part, section or provision of this Act shall be declared invalid or unconstitutional, other provisions or parts thereof which are not affected thereby shall remain in full force and effect. Section 27. Repealing Clause. - Laws or part of laws, executive orders, circulars, regulations and memoranda inconsistent with this Act are hereby repealed or amended accordingly. Section 28. Effectivity Clause. - This Act shall take effect fifteen (15) days after its publication in the Official Gazette or in two (2) newspapers of generhl circulation.

Approved, (Sgd.) PROSPERO C. NOGRALES Speaker of the House of Representatives (Sgd.) JUAN PONCE ENRILE President of the Senate

This Act which is a consolidation of Senate Bill No. 2645 and House Bill No. 3293 was finally passed by the Senate and the House of Representatives on June 3, 2009. (Sgd.) MARILYN B. BARUAYAP Secretary General House of Represenatives Approved: AUG 18 2009 (Sgd.) GLORIA MACAPAGAL-ARROYO President of the Philippines (Sgd.) EMMA LIRIO-REYES Secretary of Senate

lawphil

Republic of the Philippines Congress of the Philippines Metro Manila Fourteenth Congress First Regular Session

Begun and held in Metro Manila, on Monday, the twenty-third day of July, two thousand seven. Republic Act No. 9502 June 6, 2008 Amending RA8293, RA6675, RA5921 AN ACT PROVIDING FOR CHEAPER AND QUALITY MEDICINES, AMENDING FOR THE PURPOSE REPUBLIC ACT NO. 8293 OR THE INTELLECTUAL PROPERTY CODE, REPUBLIC ACT NO. 6675 OR THE GENERICS ACT OF 1988, AND REPUBLIC ACT NO. 5921 OR THE PHARMACY LAW, AND FOR OTHER PURPOSES Be it enacted by the Senate and House of Representatives of the Philippines in Congress assembled::

CHAPTER I GENERAL PROVISIONS Section 1. Short Title. - This Act shall be known as the "Universally Accessible Cheaper and Quality Medicines Act of 2008". SEC. 2. Declaration of Policy. - It is the policy of the State to protect public health and, when the public interest or circumstances of extreme urgency so require, it shall adopt appropriate measures to promote and ensure access to affordable quality drugs and medicines for all. Pursuant to the attainment of this general policy, an effective competition policy in the supply and demand of quality affordable drugs and medicines is recognized by the State as a primary instrument. In the event that full competition is not effective, the State recognizes as a reserve instrument the regulation of prices of drugs and medicines, with clear accountability by the implementing authority as mandated in this Act, as one of the means to also promote and ensure access to quality affordable medicines. SEC. 3. Construction in Favor of Protection of Public Health. - All doubts in the implementation and interpretation of the provisions of this Act, including its implementing rules and regulations, shall be resolved in favor of protecting public health. SEC. 4. Definition of Terms. - For purposes of this Act, the following terms are to mean as follows: (a) "Compulsory License" is a license issued by the Director General of the Intellectual Property Office to exploit a patented invention without the permission of the patent holder, either by manufacture or through parallel importation; (b) "Drug outlet" refers to drugstores, pharmacies, and any other business establishments which sell drugs and medicines; (c) "Drugs and medicines" refers to any chemical compound or biological substance, other than food, intended for use in the treatment, prevention or diagnosis of disease in humans or animals, including but not limited to: (1) any article recognized in the official United States Pharmacopoeia-National Formulary (USP-NF), official Homeopathic Pharmacopoeia of the United States, Philippine Pharmacopoeia, Philippine National Drug Formulary, British Pharmacopoeia, European Pharmacopoeia, Japanese Pharmacopoeia, Indian Pharmacopoeia, any national compendium or any supplement to any of them; (2) any article intended for use in the diagnosis, cure, mitigation, treatment, or prevention of disease in humans or animals; (3) any article other than food intended to affect the structure or any function of the human body or animals;

(4) any article intended for use as a component of any articles specified in clauses (1), (2), and (3) not including devices or their components, parts, or accessories; and (5) herbal and/or traditional drugs which are articles of plant or animal origin used in folk medicine which are: (i) recognized in the Philippine National Drug Formulary; (ii) intended for use in the treatment or cure or mitigation of disease symptoms, injury or body defects in humans; (iii) other than food, intended to affect the structure or any function of the human body; (iv) in finished or ready-to-use dosage form; and (v) intended for use as a component of any of the articles specified in clauses (i), (ii), (iii), and (iv); (d) "Essential drugs list or national drug formulary" refers to a list of drugs prepared and periodically updated by the Department of Health on the basis of health conditions obtaining in the Philippines as well as on internationally accepted criteria; (e) "Importer" refers to any establishment that imports raw materials, active ingredients and finished products for its own use or for distribution to other drug establishments or outlets; (f) "Manufacture" includes any process or part of a process for making, altering, finishing, packing, labeling, breaking or otherwise treating or adapting any drug with a view to its sale and distribution, but does not include the compounding or dispensing of any drug in the ordinary course of retail business; (g) "Manufacturer" refers to any establishment engaged in the operations involved in the production of a drug with the end view of storage, distribution, or sale of the product; (h) "Multisource pharmaceutical products" refers to pharmaceutically equivalent or pharmaceutically alternative products that may or may not be therapeutically equivalent. Multisource pharmaceutical products that are therapeutically equivalent are interchangeable; (i) "Retailer" refers to a licensed establishment carrying on the retail business of sale of drugs and medicines to customers; (j) "Trader" refers to any licensed establishment which is a registered owner of a drug product that procures the materials and packaging components, and provides the production monographs, quality control standards and procedures, but subcontracts the manufacture of such products to a licensed manufacturer; (k) "TRIPS Agreement" or Agreement on Trade-Related Aspects of Intellectual Property Rights refers

to the international agreement administered by the WTO that sets down minimum standards for many forms of intellectual property regulation; and (l) "Wholesaler" refers to a licensed establishment or drug outlet who acts as merchant, broker or agent, who sells or distributes for resale or wholesale drugs and medicines. CHAPTER 2 AMENDMENTS TO REPUBLIC ACT NO. 8293, OTHERWISE KNOWN AS THE INTELLECTUAL PROPERTY CODE OF THE PHILIPPINES SEC. 5. Section 22 of Republic Act No. 8293, otherwise known as the Intellectual Property Code of the Philippines, is hereby amended to read as follows: "SEC. 22. Non-Patentable Inventions. - The following shall be excluded from patent protection: "22.1. Discoveries, scientific theories and mathematical methods, and in the case of drugs and medicines, the mere discovery of a new form or new property of a known substance which does not result in the enhancement of the known efficacy of that substance, or the mere discovery of any new property or new use for a known substance, or the mere use of a known process unless such known process results in a new product that employs at least one new reactant. "For the purpose of this clause, salts, esters, ethers, polymorphs, metabolites, pure form, particle size, isomers, mixtures of isomers, complexes, combinations, and other derivatives of a known substance shall be considered to be the same substance, unless they differ significantly in properties with regard to efficacy; "22.2. x x x; "22.3. x x x; "22.4. x x x; "22.5. x x x; and "22.6. x x x." SEC. 6. Section 26 of Republic Act No. 8293, otherwise known as the Intellectual Property Code of the Philippines, is hereby amended to read as follows: "SEC. 26. Inventive Step. - 26.1. An invention involves an inventive step if, having regard to prior art, it is not obvious to a person skilled in the art at the time of the filing date or priority date of the application claiming the invention. (n) "26.2. In the case of drugs and medicines, there is no inventive step if the invention results from the mere discovery of a new form or new property of a known substance which does not result in the

enhancement of the known efficacy of that substance, or the mere discovery of any new property or new use for a known substance, or the mere use of a known process unless such known process results in a new product that employs at least one new reactant." SEC. 7. Section 72 of Republic Act No. 8293, otherwise known as the Intellectual Property Code of the Philippines, is hereby amended to read as follows: "SEC. 72. Limitations of Patent Rights. - The owner of a patent has no right to prevent third parties from performing, without his authorization, the acts referred to in Section 71 hereof in the following circumstances: "72.1. Using a patented product which has been put on the market in the Philippines by the owner of the product, or with his express consent, insofar as such use is performed after that product has been so put on the said market: Provided, That, with regard to drugs and medicines, the limitation on patent rights shall apply after a drug or medicine has been introduced in the Philippines or anywhere else in the world by the patent owner, or by any party authorized to use the invention: Provided, further, That the right to import the drugs and medicines contemplated in this section shall be available to any government agency or any private third party; "72.2. Where the act is done privately and on a non-commercial scale or for a non-commercial purpose: Provided, That it does not significantly prejudice the economic interests of the owner of the patent; "72.3. Where the act consists of making or using exclusively for experimental use of the invention for scientific purposes or educational purposes and such other activities directly related to such scientific or educational experimental use; "72.4. In the case of drugs and medicines, where the act includes testing, using, making or selling the invention including any data related thereto, solely for purposes reasonably related to the development and submission of information and issuance of approvals by government regulatory agencies required under any law of the Philippines or of another country that regulates the manufacture, construction, use or sale of any product: Provided, That, in order to protect the data submitted by the original patent holder from unfair commercial use provided in Article 39.3 of the Agreement on Trade-Related Aspects of Intellectual Property Rights (TRIPS Agreement), the Intellectual Property Office, in consultation with the appropriate government agencies, shall issue the appropriate rules and regulations necessary therein not later than one hundred twenty (120) days after the enactment of this law; "72.5. Where the act consists of the preparation for individual cases, in a pharmacy or by a medical professional, of a medicine in accordance with a medical shall apply after a drug or medicine has been introduced in the Philippines or anywhere else in the world by the patent owner, or by any party authorized to use the invention: Provided,

further, That the right to import the drugs and medicines contemplated in this section shall be available to any government agency or any private third party; "72.2. Where the act is done privately and on a non-commercial scale or for a non-commercial purpose: Provided, That it does not significantly prejudice the economic interests of the owner of the patent; "72.3. Where the act consists of making or using exclusively for experimental use of the invention for scientific purposes or educational purposes and such other activities directly related to such scientific or educational experimental use; "72.4. In the case of drugs and medicines, where the act includes testing, using, making or selling the invention including any data related thereto, solely for purposes reasonably related to the development and submission of information and issuance of approvals by government regulatory agencies required under any law of the Philippines or of another country that regulates the manufacture, construction, use or sale of any product: Provided, That, in order to protect the data submitted by the original patent holder from unfair commercial use provided in Article 39.3 of the Agreement on Trade-Related Aspects of Intellectual Property Rights (TRIPS Agreement), the Intellectual Property Office, in consultation with the appropriate government agencies, shall issue the appropriate rules and regulations necessary therein not later than one hundred twenty (120) days after the enactment of this law; "72.5. Where the act consists of the preparation for individual cases, in a pharmacy or by a medical professional, of a medicine in accordance with a medical "74.3. All cases arising from the implementation of this provision shall be cognizable by courts with appropriate jurisdiction provided by law. "No court, except the Supreme Court of the Philippines, shall issue any temporary restraining order or preliminary injunction or such other provisional remedies that will prevent its immediate execution. "74.4. The Intellectual Property Office (IPO), in consultation with the appropriate government agencies, shall issue the appropriate implementing rules and regulations for the use or exploitation of patented inventions as contemplated in this section within one hundred twenty (120) days after the effectivity of this law." SEC. 9. Section 76.1 of Republic Act No. 8293, otherwise known as the Intellectual Property Code of the Philippines, is hereby amended to read as follows: "SEC. 76. Civil Action for Infringement. - 76.1. The making, using, offering for sale, selling, or importing a patented product or a product obtained directly or indirectly from a patented process, or the use of a patented process without the authorization of the patentee constitutes patent infringement: Provided, That, this shall not apply to instances covered by Sections 72.1 and 72.4 (Limitations of Patent Rights); Section 74 (Use of Invention by Government); Section 93.6 (Compulsory Licensing); and Section 93-A (Procedures on Issuance of a Special Compulsory License under the TRIPS

Agreement) of this Code. "76.2. x x x; "76.3. x x x; "76.4. x x x; "76.5. x x x; and "76.6. x x x." SEC. 10. Section 93 of Republic Act No. 8293, otherwise known as the Intellectual Property Code of the Philippines, is hereby amended to read as follows: "SEC. 93. Grounds for Compulsory Licensing. - The Director General of the Intellectual Property Office may grant a license to exploit a patented invention, even without the agreement of the patent owner, in favor of any person who has shown his capability to exploit the invention, under any of the following circumstances: "93.1. National emergency or other circumstances of extreme urgency; "93.2. Where the public interest, in particular, national security, nutrition, health or the development of other vital sectors of the national economy as determined by the appropriate agency of the Government, so requires; or "93.3. Where a judicial or administrative body has determined that the manner of exploitation by the owner of the patent or his licensee is anti-competitive; or "93.4. In case of public non-commercial use of the patent by the patentee, without satisfactory reason; "93.5. If the patented invention is not being worked in the Philippines on a commercial scale, although capable of being worked, without satisfactory reason: Provided, That the importation of the patented article shall constitute working or using the patent; (Secs. 34, 34-A, 34-B, R.A. No. 165a) and "93.6. Where the demand for patented drugs and medicines is not being met to an adequate extent and on reasonable terms, as determined by the Secretary of the Department of Health." SEC. 11. A new Section 93-A is hereby inserted after Section 93 of Republic Act No. 8293, otherwise known as the Intellectual Property Code of the Philippines, to read as follows: "SEC. 93-A. Procedures on Issuance of a Special Compulsory License under the TRIPS Agreement. 93-A.1. The Director General of the Intellectual Property Office, upon the written recommendation of the Secretary of the Department of Health, shall, upon filing of a petition, grant a special compulsory license for the importation of patented drugs and medicines. The special compulsory license for the importation contemplated under this provision shall be an additional special alternative procedure to

ensure access to quality affordable medicines and shall be primarily for domestic consumption: Provided, That adequate remuneration shall be paid to the patent owner either by the exporting or importing country. The compulsory license shall also contain a provision directing the grantee the license to exercise reasonable measures to prevent the re-exportation of the products imported under this provision. "The grant of a special compulsory license under this provision shall be an exception to Sections 100.4 and 100.6 of Republic Act No. 8293 and shall be immediately executory. "No court, except the Supreme Court of the Philippines, shall issue any temporary restraining order or preliminary injunction or such other provisional remedies that will prevent the grant of the special compulsory license. "93-A.2. A compulsory license shall also be available for the manufacture and export of drugs and medicines to any country having insufficient or no manufacturing capacity in the pharmaceutical sector to address public health problems: Provided, That, a compulsory license has been granted by such country or such country has, by notification or otherwise, allowed importation into its jurisdiction of the patented drugs and medicines from the Philippines in compliance with the TRIPS Agreement. "93-A.3. The right to grant a special compulsory license under this section shall not limit or prejudice the rights, obligations and flexibilities provided under the TRIPS Agreement and under Philippine laws, particularly Section 72.1 and Section 74 of the Intellectual Property Code, as amended under this Act. It is also without prejudice to the extent to which drugs and medicines produced under a compulsory license can be exported as allowed in the TRIPS Agreement and applicable laws." SEC. 12. Section 94 of Republic Act No. 8293, otherwise known as the Intellectual Property Code of the Philippines, is hereby amended to read as follows: "SEC. 94. Period for Filing a Petition for a Compulsory License. - 94.1. A compulsory license may not be applied for on the ground stated in Subsection 93.5 before the expiration of a period of four (4) years from the date of filing of the application or three (3) years from the date of the patent whichever period expires last. "94.2. A compulsory license which is applied for on any of the grounds stated in Subsections 93.2, 93.3, 93.4, and 93.6 and Section 97 may be applied for at any time after the grant of the patent. (Sec. 34(1), R. A. No. 165)" SEC. 13. Section 95 of Republic Act No. 8293, otherwise known as the Intellectual Property Code of the Philippines, is hereby amended to read as follows: "SEC. 95. Requirement to Obtain a License on Reasonable Commercial Terms. - 95.1. The license will only be granted after the petitioner has made efforts to obtain authorization from the patent owner on reasonable commercial terms and conditions but such efforts have not been successful within a reasonable period of time.

"95.2. The requirement under Subsection 95.1 shall not apply in any of the following cases: "(a) Where the petition for compulsory license seeks to remedy a practice determined after judicial or administrative process to be anti-competitive; "(b) In situations of national emergency or other circumstances of extreme urgency; "(c) In cases of public non-commercial use; and "(d) In cases where the demand for the patented drugs and medicines in the Philippines is not being met to an adequate extent and on reasonable terms, as determined by the Secretary of the Department of Health. "95.3. In situations of national emergency or other circumstances of extreme urgency, the right holder shall be notified as soon as reasonably practicable. "95.4. In the case of public non-commercial use, where the government or contractor, without making a patent search, knows or has demonstrable grounds to know that a valid patent is or will be used by or for the government, the right holder shall be informed promptly. (n) "95.5. Where the demand for the patented drugs and medicines in the Philippines is not being met to an adequate extent and on reasonable terms, as determined by the Secretary of the Department of Health, the right holder shall be informed promptly." SEC. 14. Section 147 of Republic Act No. 8293, otherwise known as the Intellectual Property Code of the Philippines, is hereby amended to read as follows: "SEC. 147. Rights Conferred. - 147.1. Except in cases of importation of drugs and medicines allowed under Section 72.1 of this Act and of off-patent drugs and medicines, the owner of a registered mark shall have the exclusive right to prevent all third parties not having the owner's consent from using in the course of trade identical or similar signs or containers for goods or services which are identical or similar to those in respect of which the trademark is registered where such use would result in a likelihood of confusion. In case of the use of an identical sign for identical goods or services, a likelihood of confusion shall be presumed. "There shall be no infringement of trademarks or tradenames of imported or sold patented drugs and medicines allowed under Section 72.1 of this Act, as well as imported or sold off-patent drugs and medicines: Provided, That, said drugs and medicines bear the registered marks that have not been tampered, unlawfully modified, or infringed upon, under Section 155 of this Code. "147.2. x x x." SEC. 15. Section 159 of Republic Act No. 8293, otherwise known as the Intellectual Property Code of the Philippines, is hereby amended to read as follows: "SEC. 159. Limitations to Actions for Infringement. - Notwithstanding any other provision of this Act,

the remedies given to the owner of a right infringed under this Act shall be limited as follows: "159.1. x x x; "159.2 x x x; "159.3 x x x; and "159.4 There shall be no infringement of trademarks or tradenames of imported or sold drugs and medicines allowed under Section 72.1 of this Act, as well as imported or sold off-patent drugs and medicines: Provided, That said drugs and medicines bear the registered marks that have not been tampered, unlawfully modified, or infringed upon as defined under Section 155 of this Code." SEC. 16. Implementing Rules and Regulations on Amendments to Republic Act No. 8293, otherwise known as the Intellectual Property Code of the Philippines. - Unless otherwise provided herein, the Intellectual Property Office, in coordination with the Department of Health and the Bureau of Food and Drugs, shall issue and promulgate, within one hundred twenty (120) days after the enactment of this Act, the implementing rules and regulations to effectively implement the provisions of this Act that relate to Republic Act No. 8293, otherwise known as the Intellectual Property Code of the Philippines. CHAPTER 3 DRUGS AND MEDICINES PRICE REGULATION SEC. 17. Drugs and Medicines Price Regulation Authority of the President of the Philippines. - The President of the Philippines, upon recommendation of the Secretary of the Department of Health, shall have the power to impose maximum retail prices over any or all drugs and medicines as enumerated in Section 23. The power to impose maximum retail prices over drugs and medicines shall be exercised within such period of time as the situation may warrant as determined by the President of the Philippines. No court, except the Supreme Court of the Philippines, shall issue any temporary restraining order or preliminary injunction or preliminary mandatory injunction that will prevent the immediate execution of the exercise of this power of the President of the Philippines. SEC. 18. Drugs and Medicines Price Monitoring and Regulation Authority of the Secretary of the Department of Health. - To implement the policies of this Act under this Chapter, the Secretary of the Department of Health is hereby authorized to establish and initiate a price monitoring and regulation system for drugs and medicines within one hundred twenty (120) days after the enactment of this Act. The Secretary of the Department of Health may also create such bodies, consultative councils, from which advice may be sought in the implementation of a drug or medicine price monitoring and regulation policy. Such bodies or consultative councils created by the Secretary of the Department of Health shall coordinate its efforts together with other government agencies. SEC. 19. Functions and Responsibilities of the Secretary of the Department of Health. - Pursuant to Section 18 of this Act, the Secretary of the Department of Health shall have the following powers: (A) Power to Recommend the Maximum Retail Price of Drugs and Medicines Subject to Price Regulation - (1) Upon application or motu proprio when the public interest so requires, the Secretary

of the Department of Health shall have the power to determine the maximum retail prices of drugs and medicines which shall be recommended to the President of the Philippines for approval. In order that affordable prices of drugs and medicines from the different manufacturers, importers, traders, distributors, wholesalers, or retailers shall be made available to the public, the Secretary of the Department of Health, as he/she may deem fit and after a proper determination, shall have such approved maximum retail prices of drugs and medicines published; (2) In recommending the maximum retail price, the Secretary of the Department of Health shall consider the following factors: (a) Retail prices of drugs and medicines that are subject to regulation in the Philippines and in other countries; (b) The supply available in the market; (c) The cost to the manufacturer, importer, trader, distributor, wholesaler or retailer of the following, but not limited to: (i) The exchange rate of the peso to the foreign currency with which the drug or any of its component, ingredient or raw material was paid for; (ii) Any change in the amortization cost of machinery brought about by any change in the exchange rate of the peso to the foreign currency with which the machinery was bought through credit facilities; (iii) Any change in the cost of labor brought about by a change in minimum wage; or (iv) Any change in the cost of transporting or distributing the medicines to the area of destination; (d) Such other factors or conditions which will aid in arriving at a just and reasonable maximum price; and (3) No retailer shall sell drugs and medicines at a retail price exceeding the maximum retail price approved by the President of the Philippines as provided in Section 17 of this Act: Provided, That, the Secretary of the Department of Health shall immediately undertake a study on the prevailing prices of drugs and medicines subject to price regulation and provide an initial list of drugs and medicines, which maximum retail prices he/she shall recommend to the President of the Philippines. (B) Power to Include Other Drugs and Medicines in the List Subject to Price Regulation - Upon application or motu proprio when the public interest so requires and after proper determination, the Secretary of the Department of Health may order the inclusion of drugs and medicines to the list subject of price regulation under Section 23 hereof.

(C) Power to Implement Cost-Containment and Other Measures - (1) The Secretary of the Department of Health shall have the power to implement the fair price of drugs and medicines for purposes of public health insurance and government procurement based on the order of the President of the Philippines imposing maximum retail prices; and (2) The Secretary of the Department of Health shall have the power to implement any other measures that the government may avail of to effectively reduce the cost of drugs and medicines that shall include, but not limited to, competitive bidding, price volume negotiations, and other appropriate mechanisms that influence supply, demand and expenditures on drugs and medicines. (D) Power to Impose Administrative Fines and Penalties - After due notice and hearing, the Secretary of the Department of Health shall have the power to impose administrative fines against any person, manufacturer, importer, trader, distributor, wholesaler, retailer, or any other entity, in such amount as it may deem reasonable, which in no case shall be less than Fifty thousand pesos (Php50,000.00) nor more than Five million pesos (Php5,000,000.00) for violations of the maximum retail price approved by the President of the Philippines pursuant to the provisions of this Chapter. (E) Power to Deputize Government Entities - The Secretary of the Department of Health shall have the power to call upon and deputize any official, agent, employee, agency, or instrumentality of the national and local government for any assistance that it may deem necessary to carry out the purposes of this Chapter. (F) Other Powers Necessary to Implement Provisions of this Chapter - The Secretary of the Department of Health shall exercise such powers and functions as may be necessary to implement and enforce the provisions of this Chapter of this Act, including the power to require the production and submission of records, documents, books of account, bills of lading, input documents, records of purchase and sale, financial statements, and such other documents, information and papers as may be necessary to enable the Secretary of the Department of Health to carry out its functions, duties, and responsibilities. Accordingly, within thirty (30) days from the effectivity of this Act and every December 31st of every year thereafter, every manufacturer, importer, trader, distributor, wholesaler, and retailer of a drug and medicine whether included in or excluded from the list of drugs and medicines that are subject to price regulation shall furnish the Secretary of the Department of Health a list, containing on the minimum the corresponding prices and inventory, of all drugs and medicines it manufactures, imports, trades, distributes, wholesales, or retails, data pertaining to the factors enumerated under Section 19(A)(2), and any and all necessary information that the Secretary of the Department of Health may require. SEC. 20. Procedures for Inquiries, Studies, Hearings, Investigations, and Proceedings. - All inquiries, studies, hearings, investigations and proceedings conducted by the Secretary of the Department of Health shall be governed by the rules adopted by him/her, and in the conduct thereof shall not be bound by the technical rules of evidence. SEC. 21. Effectivity of the Decisions or Orders of the Secretary of the Department of Health. - All decisions or orders of the Secretary of the Department of Health pursuant to Section 19 Paragraphs (A) Power to Recommend the Maximum Retail Price of Drugs and Medicines Subject to Price Regulation, (B) Power to Include Other Drugs and Medicines in the List Subject to Price Regulation, (C) Power to Implement Cost-Containment and Other Measures, (D) Power to Impose Administrative Fines and Penalties, (E) Power to Deputize Government Entities, or (F) Other

Powers Necessary to Implement Provisions of this Chapter, shall be immediately operative. SEC. 22. Review of the Decisions or Orders of the Secretary of the Department of Health. - A party adversely affected by a decision, order or ruling of the Secretary of the Department of Health may, within thirty (30) days from notice of such decision, order or ruling, or in case of a denial of a motion for reconsideration thereof, within fifteen (15) days after notice of such denial, file an appeal with the Court of Appeals, which shall have jurisdiction to review such decision, order or ruling. The filing of a petition for a writ of certiorari or other special remedies in the Supreme Court shall in no case supersede or stay any decision, order or ruling of the Secretary of the Department of Health, unless the Supreme Court shall so direct, and the petitioner may be required by the Supreme Court to give bond in such form and of such amount as may be deemed proper. SEC. 23. List of Drugs and Medicines that are Subject to Price Regulation. - The list of drugs and medicines that are subject to price regulation shall include, inter alia: (a) All drugs and medicines indicated for treatment of chronic illnesses and life threatening conditions, such as, but not limited to, endocrine disorders, e.g., diabetes mellitus; gastrointestinal disorders, e.g., peptic ulcer; urologic disorders, e.g., benign prostatic hyperplasia (BPH); cardiovascular diseases, e.g., hypertension; pulmonary diseases, e.g., pulmonary tuberculosis (PTB), asthma; auto-immune diseases, e.g., systemic lupus erythematosus (SLE); skin diseases, e.g., psoriasis; neuro-psychiatric disorders; other infectious diseases, e.g., human immunodeficiency virus-acquired immune deficiency syndrome (HIV-AIDS); and other conditions such as organ transplants and neoplasm; (b) Drugs and medicines indicated for prevention of diseases, e.g., vaccines, immunoglobulin, anti-sera; (c) Drugs and medicines indicated for prevention of pregnancy, e.g., oral contraceptives; (d) Anesthetic agents; (e) Intravenous fluids; (f) Drugs and medicines that are included in the Philippine National Drug Formulary (PNDF) Essential Drug List; and (g) All other drugs and medicines which, from time to time, the Secretary of the Department of Health determines to be in need of price regulation. SEC. 24. Illegal Acts of Price Manipulation. - Without prejudice to the provisions of existing laws on goods not covered by this Act, it shall be unlawful for any manufacturer, importer, trader, distributor, wholesaler, retailer, or any person engaged in any method of disposition of drugs and medicines to engage in acts of price manipulation such as hoarding, profiteering, or illegal combination or forming cartel, as defined under Section 5 of Republic Act No. 7581, otherwise known as the Price Act, and all other acts committed in restraint of trade. SEC. 25. Penalty for Illegal Acts of Price Manipulation. - Any person or entity who commits any act of illegal price manipulation of any drug and medicine subject to price regulation shall suffer the penalty of imprisonment for a

period of not less than five (5) years nor more than fifteen (15) years or shall be imposed a fine of not less than One hundred thousand pesos (Php100,000.00) nor more than Ten million pesos (Php10,000,000.00), at the discretion of the court. The court may also order the suspension or revocation of its license to operate (LTO), professional or business license. Whenever any act of illegal price manipulation of any drug and medicine subject to price regulation is committed by a juridical person, its officials or employees, or in case of a foreign corporation or association, its agent or representative in the Philippines who are responsible for the violation, shall be held liable therefor. SEC. 26. Display of Maximum Retail Price Fixed and Approved by Order of the President of the Philippines for Drugs and Medicines Subject to Price Regulation. - (a) Within a reasonable period as may be determined by the Secretary of the Department of Health, and: Provided, That it conforms to existing drug product labeling requirements, every manufacturer, importer, distributor, wholesaler, trader, or retailer of a drug and medicine intended for sale shall display the retail price which shall not exceed the maximum retail price approved by order of the President of the Philippines. The maximum retail price shall be printed on the label of the immediate container of the drug and medicine and the minimum pack thereof offered for retail sale with the words "RETAIL PRICE NOT TO EXCEED" preceding it, and "UNDER DRUG PRICE REGULATION" on a red strip. (b) Within a period as may be determined by the Secretary of the Department of Health from time to time, every manufacturer, importer, or trader shall issue a price list to wholesalers, distributors, retailers and to the Secretary of the Department of Health, indicating the retail price, the maximum retail price, and such other information as may be required by the Secretary of the Department of Health. SEC. 27. Reports from Local Government Units (LGUs) and the Department of Trade and Industry (DTI). - All local government units and the Department of Trade and Industry shall help ensure the implementation of pricing policies provided under this Chapter by submitting quarterly price monitoring reports to the Secretary of the Department of Health of drugs and medicines identified by the latter, and any and all necessary information that the Secretary of the Department of Health may require. SEC. 28. Role of the Department of Health (DOH) and the Department of Trade and Industry (DTI). - The Department of Health and the Department of Trade and Industry shall conduct independent periodic surveys and studies of the selling prices of all drugs and medicines referred to in Section 23 of this Act all over the country as well as their share or effect on the family income of the different economic groups in the country for purposes of serving as data base for government efforts to promote access to more affordable medicines, as well as evaluating the effectivity of the measures undertaken to promote access to more affordable medicines. The DTI shall always officially provide the Secretary of the Department of Health copies of these independent reports. SEC. 29. Rules and Regulations. - The Secretary of the Department of Health, in consultation with the Department of Trade and Industry, the Congressional Oversight Committee and other appropriate government agencies, shall, within one hundred twenty (120) days from the effectivity of this Act, promulgate the rules and regulations necessary to effectively implement the provisions of this Chapter. SEC. 30. Reportorial and Public Notice Requirements. - (a) The Secretary of the Department of Health shall submit a bi-annual Monitoring Report of its performance on the implementation of this Act to the Office of the President. This report submitted to the Office of the President shall be published in a newspaper of general circulation within thirty

(30) days upon submission. (b) It shall also submit annually a report of its performance on the implementation of this Act to both Houses of Congress, within fifteen (15) days from the opening of the regular session. It shall also regularly report and comply immediately to any order of the Congressional Oversight Committee. (c) The order of the President of the Philippines imposing maximum retail prices on drugs and medicines, including the conditions implementing it, shall be published within fifteen (15) days from issuance in at least two (2) newspapers of general circulation. All wholesalers, manufacturers, distributors, importers, or traders shall have a copy of the order of the President of the Philippines and provide the same to their clients and customers for every transaction. (d) All drug outlets are required to post in a conspicuous area within its premises a clear copy of the order of the President of the Philippines which shall be easily accessible to the consuming public and updated regularly as the situation may warrant. CHAPTER 4 STRENGTHENING OF THE BUREAU OF FOOD AND DRUGS SEC. 31. Strengthening of the Bureau of Food and Drugs (BFAD). - (a) For a more effective and expeditious implementation of this Act, the Director or head of the Bureau of Food and Drugs shall be authorized to retain, without need of a separate approval from any government agency, and subject only to existing accounting and auditing rules and regulations, all the fees, fines, royalties and other charges, collected by the Bureau of Food and Drugs under this Act and other laws that it is mandated to administer based on the immediately prior year of operations, for use in its operations, like upgrading of its facilities, equipment outlay, human resource development and expansion, and the acquisition of the appropriate office space, among others, to improve the delivery of its services to the public. This amount, which shall be in addition to the annual budget of the Bureau of Food and Drugs, shall be deposited and maintained in a separate account or fund, which may be used or disbursed directly by the Director or head. (b) After five (5) years from the coming into force of this Act, the Director or head of the Bureau of Food and Drugs shall, subject to the approval of the Secretary of the Department of Health, determine if the fees and charges, mentioned in Subsection (a) hereof, are sufficient to meet its budgetary requirements. If so, it shall retain all the fees and charges it shall collect under the same conditions indicated in said Subsection (a) but shall forthwith, cease to receive any funds from the annual budget of the National Government; if not, the provisions of Subsection (a) shall continue to apply until such time when the Director or head of the Bureau of Food and Drugs, subject to the approval of the Secretary of the Department of Health, certifies that the abovestated fees and charges the Bureau of Food and Drugs shall collect are enough to fund its operations. (c) The Bureau of Food and Drugs shall submit a yearly performance report to the Quality Affordable Medicines Oversight Committee, as provided in Section 45 of this Act. The report shall itemize the use of such retained funds in the past year up to the present and the budgeted use of the same in the succeeding periods. SEC. 32. Quality Assurance of Drugs. - The Bureau of Food and Drugs shall take the necessary steps to ensure that all drugs authorized for marketing in the country shall conform to international standards for the content, purity and

quality of pharmaceutical products as established in the International Pharmacopoeia: Provided, That imported products in finished dosage forms, should be certified under the World Health Organization (WHO) certification scheme on the quality of pharmaceutical products moving in international commerce: Provided, further, That the registration for multisource pharmaceutical products should conform to the WHO guidelines on registration requirements to establish interchangeability. CHAPTER 5 NON-DISCRIMINATORY CLAUSE SEC. 33. Non-Discriminatory Clause. - It shall be unlawful for any retail drug outlet to refuse to carry either by sale or by consignment, or offer for sale drugs and medicines brought into the country, as allowed under Section 7 of this Act which amends Section 72.1 of the Intellectual Property Code of the Philippines or Republic Act No. 8293, by the government or authorized third party which have been previously approved for distribution or sale by the Bureau of Food and Drugs. For this purpose, the said products shall be displayed with equal prominence as all other products sold in the establishment. SEC. 34. Refusal to Sell Drugs and Medicines. - No manufacturer, importer, trader, distributor, wholesaler shall withhold from sale or refuse to sell to a wholesaler or retailer any drug or medicine without good and sufficient reasons. SEC. 35. Penalties. - Any person or entity who shall refuse to carry or sell drugs and medicines pursuant to the provisions of this Chapter shall be punished with a fine of not less than One hundred thousand pesos (Php100,000.00) but not more than Five hundred thousand pesos (Php500,000.00), at the discretion of the court. For the succeeding offense, the penalties shall not be less than Five hundred thousand pesos (Php500,000.00) but not more than One million pesos (Php1,000,000.00), at the discretion of the court, and suspension or revocation of its license to operate (LTO), business or professional license, as the case may be. SEC. 36. Implementing Rules and Regulations on the Non-Discriminatory Clause. - Within one hundred twenty (120) days from the effectivity of this Act, the Department of Health, in consultation with the Department of Trade and Industry, shall promulgate the rules and regulations necessary to effectively implement the provisions of this Chapter. CHAPTER 6 AMENDMENTS TO REPUBLIC ACT NO. 6675, OTHERWISE KNOWN AS THE GENERICS ACT OF 1988 SEC. 37. Section 5 of Republic Act No. 6675, otherwise known as the Generics Act of 1988, is hereby amended to read as follows: "SEC. 5. Posting and Publication. - The Department of Health shall publish annually in acceptable means of public dissemination in at least two (2) newspapers of general circulation in the Philippines the generic names, and the corresponding brand names under which they are marketed, of all drugs and medicines available in the Philippines." SEC. 38. Section 6 of Republic Act No. 6675, otherwise known as the Generics Act of 1988, is hereby amended to

read as follows: "SEC. 6. Who Shall Use Generic Terminology. - (a) All government health agencies and their personnel as well as other government agencies shall use generic terminology or generic names in all transactions related to purchasing, prescribing, dispensing and administering of drugs and medicines. "(b) All medical, dental and veterinary practitioners, including private practitioners, shall write prescriptions using the generic name. The brand name may be included if so desired. "(c) Any organization or company involved in the manufacture, importation, repacking, marketing and/or distribution of drugs and medicines shall indicate prominently the generic name of the product. In the case of brand name products, the generic name shall appear prominently and immediately above the brand name in all product labels as well as in advertising and other promotional materials. "(d) Drug outlets, including drugstores, hospital and non-hospital pharmacies and nontraditional outlets such as supermarkets and stores, shall inform any buyer about any and all other drug products having the same generic name, together with their corresponding prices so that the buyer may adequately exercise his option. Within one (1) year after the approval of this Act, the drug outlets referred to herein shall post in conspicuous places in their establishments a list of drug products with the same generic name and their corresponding prices. "(e) There shall appear prominently on the label of a generic drug the following statement: this product has the same therapeutic efficacy as any other generic product of the same name. Signed: BFAD." SEC. 39. Section 8 of Republic Act No. 6675, otherwise known as the Generics Act of 1988, is hereby amended to read as follows: "SEC. 8. Required Production. - Subject to the rules and regulations promulgated by the Secretary of Health, every drug manufacturing company operating in the Philippines shall be required to produce, distribute and make widely available to the general public an unbranded generic counterpart of their branded product." SEC. 40. Section 11 of Republic Act No. 6675, otherwise known as the Generics Act of 1988, is hereby amended to read as follows: "SEC. 11. Education Drive. - The Department of Health jointly with the Philippine Information Agency and the Department of the Interior and Local Government shall conduct a continuous information campaign for the public and a continuing education and training for the medical and allied medical professions on drugs with generic names as an alternative of equal efficacy to the more expensive brand name drugs. Such educational campaign shall include information on the illnesses or symptoms which each generically named drug is supposed to cure or alleviate, as well as in contraindications. The Department of Health with the assistance of the Department of the Interior and Local Government and the Philippine Information Agency shall monitor the progress of the education drive, and shall submit regular reports to Congress."

SEC. 41. Section 12 of Republic Act No. 6675, otherwise known as the Generics Act of 1988, is hereby amended to read as follows: "SEC. 12. Penalty. - (A) Any person who shall violate Section 6(a) or 6(b) of this Act shall suffer the penalty graduated hereunder, viz: "(a) for the first conviction, he shall suffer the penalty of reprimand which shall be officially recorded in the appropriate books of the Professional Regulation Commission. "(b) for the second conviction, the penalty of fine in the amount of not less than Ten thousand pesos (Php10,000.00) but not exceeding Twenty-five thousand pesos (Php25,000.00), at the discretion of the court. "(c) for the third conviction, the penalty of fine in the amount of not less than Twenty-five thousand pesos (Php25,000.00) but not exceeding Fifty thousand pesos (Php50,000.00) and suspension of his license to practice his profession for sixty (60) days at the discretion of the court. "(d) for the fourth and subsequent convictions, the penalty of fine of not less than One hundred thousand pesos (Php100,000.00) and suspension of his license to practice his profession for one (1) year or longer at the discretion of the court. "(B) Any juridical person who violates Sections 6(c), 6(d), 7 or 8 shall suffer the penalty of a fine of not less than One hundred thousand pesos (Php100,000.00) and suspension or revocation of license to operate such drug establishment or drug outlet at the discretion of the court: Provided, That its officers directly responsible for the violation shall suffer the penalty of fine of at least Forty thousand pesos (Php40,000.00) and suspension or revocation of license to practice profession, if applicable, and by imprisonment of not less than six (6) months nor more than one (1) year or both fine and imprisonment at the discretion of the court: and, a list of drug products with the same generic name and their corresponding prices. Provided, further, That if the guilty party is an alien, he shall be ipso facto deported after service of sentence without need of further proceedings. "(C) The Secretary of Health shall have the authority to impose administrative sanctions such as suspension or cancellation of license to operate or recommend suspension of license to practice profession to the Professional Regulation Commission as the case may be for the violation of this Act. "The administrative sanctions that shall be imposed by the Secretary of the Department of Health shall be in a graduated manner in accordance with Section 12.A. "An administrative case may be instituted independently from the criminal case: Provided, That, the dismissal of the criminal case or the withdrawal of the same shall in no instance be a ground for the dismissal of the administrative case." SEC. 42. Implementing Rules and Regulations to the Amendments to the Generics Act of 1988. - The Department of

Health, in consultation with the appropriate government agencies, shall, within one hundred twenty (120) days from the effectivity of this Act, promulgate the rules and regulations necessary to effectively implement the provisions of this Act that relate to Republic Act No. 6675, or the Generics Act of 1988. CHAPTER 7 AMENDMENTS TO REPUBLIC ACT NO. 5921, AS AMENDED, OTHERWISE KNOWN AS THE PHARMACY LAW SEC. 43. Section 25 of Republic Act No. 5921, as amended, otherwise known as the Pharmacy Law, is hereby amended to read as follows: "SEC. 25. Sale of medicine, pharmaceuticals, drugs and devices. - No medicine, pharmaceutical, or drug, except for those which are non-prescription or over-the-counter, of whatever nature and kind or device shall be compounded, dispensed, sold or resold, or otherwise be made available to the consuming public except through a prescription drugstore or hospital pharmacy, duly established in accordance with the provisions of this Act. Non-prescription or over-the-counter drugs may be sold in their original packages, bottles, containers or in small quantities, not in their original containers to the consuming public through supermarkets, convenience stores and other retail establishments. "Pharmaceutical, drug or biological manufacturing establishments, importers and wholesalers of drugs, medicines, or biologic products, shall not sell their products for re-sale except only to retail drug outlets, hospital pharmacies or to other drug wholesalers under the supervision of a registered pharmacist, and supermarkets, convenience stores, other retail establishments for over-the-counter drugs, duly licensed by the Bureau of Food and Drugs." SEC. 44. Implementing Rules and Regulations to the Amendments to the Pharmacy Law. - The Department of Health, in consultation with the appropriate government agencies, within one hundred twenty (120) days from the effectivity of this Act, shall promulgate the rules and regulations necessary to effectively implement the provisions of this Chapter. CHAPTER 8 MISCELLANEOUS PROVISIONS SEC. 45. Congressional Oversight Committee. - For the effective implementation of this Act, there shall be created a Congressional Oversight Committee, hereinafter referred to as the Quality Affordable Medicines Oversight Committee, to be composed of five (5) members from the Senate, which shall include the Chairpersons of the Senate Committees on Trade and Commerce and Health and Demography, and, five (5) members from the House of Representatives, which shall include the Chairpersons of the House of Representatives Committees on Trade and Industry and Health. The Quality Affordable Medicines Oversight Committee shall be jointly chaired by the Chairpersons of the Senate Committee on Trade and Commerce and the House of Representatives Committee on Trade and Industry. The Vice-Chair of the oversight committee shall be jointly held by the Chairpersons of the Senate Committee on Health and Demography and the House of Representatives Committee on Health. SEC. 46. Appropriations. - For the initial implementation of this Act, the amount of Twenty-five million pesos

(Php25,000,000.00), in addition to the budget of the Department of Health, shall be provided for the operations of the Office of the Secretary of the Department of Health. The Quality Affordable Medicines Oversight Committee shall be provided an initial budget of Five million pesos (Php5,000,000.00) to perform its functions as mandated under this Act. Thereafter, such sum as may be necessary for its continued implementation shall be included in the annual General Appropriations Act. SEC. 47. Separability Clause. - Any portion or provision of this Act that may be declared unconstitutional or invalid shall not have the effect of nullifying other portions and provisions hereof as long as such remaining portion or provision can still subsist and be given effect in their entirety. SEC. 48. Repealing Clause. - All laws, decrees, executive orders, proclamations and administrative regulations or parts thereof inconsistent herewith are hereby repealed or modified accordingly. SEC. 49. Effectivity Clause. - This Act shall take effect fifteen (15) days after its publication in at least two (2) national papers of general circulation. Approved, (Sgd.) PROSPERO C. NOGRALES Speaker of the House of Representatives (Sgd.) MANNY VILLAR President of the Senate

This Act which is a consolidation of Senate Bill No. 1658 and House Bill No. 2844 was finally passed by the Senate and the House of Representatives on April 29, 2008. (Sgd.) MARILYN B. BARUAYAP Secretary General House of Represenatives Approved: JUN 06, 2008 (Sgd.) GLORIA MACAPAGAL-ARROYO President of the Philippines (Sgd.) EMMA LIRIO-REYES Secretary of Senate