AO 2016 0008 Revised Labeling Presentation

Republic of the Philippines
Department of Health
Food and Drug Administration
Administrative Order No. 2016-0008

Revised Rules and Regulations Governing the
Generic Labeling Requirements of Drug
Products for Human Use
Center for Drug Regulation and Research

1
Presentation Outline
A. Background
B. Regulation: Administrative
Order No. 2016-0008
C. Mandatory Information for
Specific Labeling Material
D.Implementation Arrangement
E. Discussion
2
Revised Labeling Regulation
A. BACKGROUND
3
Full adoption of ACTD/ACTR

4
5
Gaps
Harmonization
Patient information for OTC
Issues on graphics
Required information
Strengthening of PV

6
Timelines
2006 – initial drafting by then PSD and
PPAD
May 2013 – endorsement to CDRR

7
Focus Group Discussion

8
Comments and Suggestions
22 May – 28 Jul – 2 comments/position
papers received
28 Jul – 25 Aug – 3 comments

9
Public Hearing

10
Administrative Order No.
2016-0008

11
ONAR Bulletin Vol. 6 No. 13

12
ONAR Bulletin Vol. 6 No. 13

13
Publishing: Philippine Daily Inquirer

14
Publishing: Philippine Star

15

B. REGULATION:
ADMINISTRATIVE ORDER NO.
2016-0008
16
II. Objective
rationalize the existing rules and
regulations on generic labeling
requirements of drug products,
consistent with the harmonized
requirements of the ASEAN
Member States

17
III. Scope
all manufacturers, traders and
distributors (i.e. exporters, importers
and wholesalers) of pharmaceutical
products for human use, including
herbal and traditional medicines

18
IV. Definition of Terms
(1) Active Moiety
The molecule, or ion, excluding those
appended portions of the molecule that
cause the drug to be an ester, salt (including a salt
with hydrogen or coordination bonds), or other non-
covalent derivative (such as complex, chelate, or
clathrate) of the molecule, responsible for the
physiological or pharmacological action of
the drug substance

19
(17) Generic Class Name
The identification of a pharmaceutical
product containing those three or
more APIs by its scientifically and
internationally recognized name
or by its official generic name as
determined by FDA

20
(42) Small Containers
Are pharmaceutical packaging materials that hold
less than or equal to 5 mL volume or 5 g
weight, which include:
a) Ampoules, vials, and nebules of small volume
parenterals
b) Packaging materials for ophthalmic, otic, and nasal
liquid preparations
c) Jars and tubes for semi-solid preparations; and
d) Any other pacakging material of the same capacity

21
V. General Guidelines
Minimum Mandatory Information
1) Product Name
2) Dosage Form and Strength
3) Pharmacologic Category
4) Formulation/Composition
5) Indication(s)
6) Dosage and Mode of Administration

22
7) Contraindication(s), Precaution(s),
Warning(s) (if applicable)
8) Interactions
9) Adverse Drug Reaction(s)
10)Overdose and Treatment
11)Storage Condition(s)
12)Net Content or Pack Size
13)Name and Address of MAH

23
14)Name and Address of Manufacturer
15)Rx Symbol and Caution Statement
16)ADR Reporting Statement
17)Registration Number
18)Batch Number and Lot Number (if any)
19)Expiration Date and Date of Manufacture

24
General Requirements
1) English and/or Filipino
2) Readable with normal vision without
straining
3) NCEs, biologics, and Rx generic and
herbal products –PI
4) HR, OTCs, Herbal non-Rx, TM – PIL
5) NCEs and biologics – PI must be based
from SPC
25
In lieu of PI or PIL - printed directly on
the reverse side or inner panel of
the outer packaging material or
inner carton; provided, that the
product is intended to be sold or
dispensed together with such
packaging material or inner carton

26
Products without product
information and unit carton –
minimum mandatory information shall
be reflected on the primary label

27
Principal display panel and side panel

28

VI. SPECIFIC GUIDELINES
A. REQUIREMENTS FOR EACH MANDATORY INFORMATION

29
Product Name
1) Generic and brand name (if any)
2) Generic name – as active moiety based
on INN, consistent with the dosage strength;
prodrugs – INN of prodrug
3) Generic name shall appear prominently,
enclosed in an outline box;
prominence over other information as
determined by common visual sense

30
Product Name
4)Herbal and TM: Botanical origin or
as recognized by FDA
5)Generic name shall appear above
brand name; for narrative texts, the
brand name shall be preceded by
the generic name and shall be
enclosed in parenthesis or
brackets
31
Product Name
6) Multiple APIs - all APIs shall be
indicated, in order of decreasing
pharmacological activity; if more
or less similar activity, in decreasing
potency; provided that if single
approved name for FDC, single
approved name shall be used;

32
Product Name
provided further if there is no single
approved name but a generic class
name exist, generic class name shall
be used.
The individual components shall
be indicated under formulation

33
Product Name
6) Multiple APIs:
B
A

34
Product Name
Generic name and brand name in the same
font style and color
Generic name one point size bigger
Color of generic outline box is same w/
generic name font color
Background color of generic box is same with
brand name background

35
Dosage Form and Strength
1) Label shall specify:
a) Dosage form (tablet vs capsule)
b) Special delivery system (sustained-
release vs. extended-release)
c) Specific mode of administration (vaginal
vs. rectal) if any and appropriate are
required
d) No qualifier for tablets – oral, uncoated,
IR tablet
36
2) dosage strength - expressed in
metric units reduced to lowest
terms and in the number of the largest
unit specified (e.g. 500mcg, not
0.5mg)
3) strength of certain dosage forms to
be expressed as percentage

37
4) For multiple APIs: dosage strength of
each API shall be stated in accordance
with the arrangement of the APIs,
separated by a slash sign (/); provided,
that if a single approved name of the
combination drug is used, the
dosage strength shall be indicated as
the whole

38

39
Pharmacologic Category
As determined by FDA

40
Formulation/Composition
1)Name and strength of all APIs
present per unit dose of product in generic
names, arranged in decreasing potency
2) Name of API shall be stated in full
(including salts and esters, if any), and
correlated to the active moiety when
applicable; shall be in accordance with
INN; for herbal/TM – in accordance with
PP or FDA approved name
41
3)reference monograph of the
finished product shall be indicated,
unless non-official; for multiple API, it
shall be indicated after the first
API

42

43
4) Alcohol must be expressed as percentage;
alcohol without qualification - ethanol
5) Coloring agents and other excipients used
in the manufacture that may cause
hypersensitivity and/or other adverse
reactions shall also be indicated, with the
amount expressed in the same manner as the
API
6) Preservative/antimicrobial agents shall
be indicated, with the amount expressed in
the same manner as the API
44
Indication
Only FDA approved clinical use

45
Dosage and Mode of
Administration
1) Recommended dosage, where
applicable:
a) Initial/loading dose
b) Optimal use or usual dose
c) Frequency interval
d) Duration of treatment
e) Dosage adjustment
46
Dosage and Mode of
Administration
2) Dilution/ reconstitution/
preparation instructions in all
labeling materials; description of the
reconstituted preparation
3) Dosage for special populations, adults and
children; if not for children, “adult
dose” or any statement to that effect

47
Contraindication(s),
Precaution(s), Warning(s)
1) Full information on contraindication, as
well as the precautions to be observed
2) Special warnings should be included as
required and specified by FDA
3) For products are to be used on one
occasion only, “single use only”, “single
dose”, or any statement to that effect

48
Special Warnings
• Products Containing Sodium Metabisulfite and
Other Derivatives of this Sodium Salt
• Habit Forming Products
• Antidepressant Drugs
• Erythromycin Products
• Products Containing Phenylpropanolamine (PPA)
• Selective COX-II Inhibitors and Prescription Non-
steroidal Anti-inflammatory Drugs (NSAIDs)
• Azithromycin Products
49
Interactions
1) Drug-Drug
2) Drug-Food
3) Drug-Laboratory test
4) Other relevant

50
Adverse Drug Reaction(s)
Shall include detailed information on
ADRs for a drug product arranged by
system organ class

51
Overdose and Treatment
1) Signs and Symptoms of Overdose
2) Treatment for overdose

52
Storage Condition
1) Appropriate storage conditions and special
instructions for handling (e.g. cold chain)
2) Special labelling instructions:

53
Pack Size/Net Content
1) Unit carton – pack size expressed in terms of
the number of units or the volume of
each unit; for reconstitution products, the
reconstituted volume 100 Tablets
10 Blister Packs x 10 Tablets
12 Sachets x 5g
60mL
12 vials x 5mL
54
Pack Size/Net Content
2) Primary label (except blisters and foil
strips) – net content stating the total
amount/quantity of dosage form in
a given container
100 Tablets
5g
60mL
5mL
55
MAH
Name and address of MAH
Market Authorization Holder:

Pavenus Ltd
Mother Ignacia cor. Sgt. Esguerra
St., Diliman Quezon City

56
Manufacturer
Name and specific manufacturing site
address of manufacturer
Market Authorization Holder:

Pavenus Ltd
Mother Ignacia cor. Sgt. Esguerra St., Diliman Quezon
City
Manufacturer:
Will Del Una Intl
Rm. 128, 1st Flr Main Building, Alabang, Muntinlupa

57
Rx Symbol and Caution Statement
1) Required for prescription products;

allowed to be over-printed or
superimposed
2) Caution Statement – unit carton,
primary label except blister pack, foil
strip, and small containers, and
package insert:

58
Rx Symbol and Caution Statement
Foods, Drugs, Devices, and Cosmetics

Act prohibits dispensing without
prescription.
For Dangerous Drugs, additional
caution statement as specified by PDEA

59
ADR Reporting Statement
For product information sheet, unit carton or
primary label except blister apck, foil strip, and small
containers of productes intended to be sold without
a unit carton:
For suspected adverse drug reaction,
report to the FDA: www.fda.gov.ph”
instruction to the patient to seek medical
attention immediately at the first sign of
ADR
MAH may also include reporting statement for their
own PV system
60
Registration Number
Registration number assigned by FDA

61
Batch and Lot Number
Batch number if marketed by one drug
establishment
if batch is divided into lots marketed
by different establishments, lot and
batch number

62
Expiration/Manufacturing Date
1)Month and year is required; if

stated in numbers alone, year is
stated completely; if day is
specified, month is spelled out
a) June 2007
b) 07/2007
c) 03 June 2007 or 03 Jun 2007
63
Expiration/Manufacturing Date
2) understood to be the last day of the
month if no day specified
3) For reconstituted products or can be
administered multiple times, the
label shall include the period of
guaranteed safety and efficacy
after first opening at a given storage
condition

64
Special Labeling
Instructions: Parenterals
1) “intravenous”, “intramuscular” or
“subcutaneous”
2) For concentrated solution – direction
not to administer the solution
undiluted and direction to dilute w/
specified diluent

65
Special Labeling Instructions:
Fluid Replacement Products
1) Those that follow standard
formulations contained in official
compendium, the nomenclature
used in the official compendium
shall be adopted as the generic
class name;
2)Non-official solutions – FDA shall
determine generic class name
66
3) directly below the generic class
name but still inside the generic
outline box – individual
components (including excipients)
w/ corresponding mEq/L or
mmol/L enumerated in the order of
decreasing pharmacologic activity
67
4)amino acids and/or proteins -
total amount of nitrogen
5) Nominal osmolality (e.g.
“hypotonic” or “hypertonic”)and
nominal pH range

68
For External Use
Rendered in all capital letters and red
background or red font
Ex.

69
Biological Products
Additional info on the formulation:
1) name of the species of animal or
organism from which the product has
been prepared;
2) name of any adjuvant in the product or
any substance which, when
administered with an antigen,
modifies the immune response to
that antigen
70
Multivitamin/Mineral/Herbal Products with Standard
Formulations and Non-vitamin/mineral/herbal
Components
1)Generic class name -
Multivitamins and Minerals for
multi-vitamin and multi-mineral
containing products (atleast 3)
2) For multi-vitamin/mineral containing
products with additional herbal
ingredients (at least 3) – generic
class name shall be herbs
71
Components
3) For multivitamin products with non-
vitamin components, or multi-mineral
products with non-mineral
components, or multi-herbal products
with non-herbal components, the term
“Multivitamins” or “Minerals” or “Herbs”,
respectively, shall first be stated, followed
by the generic name of the specific additional
individual components
72
Components

73
Physician’s Samples
1) In addition to the minimum requirements,
each individual dosage unit of the
physician’s sample shall include batch
and/or lot numbers, date of
manufacture and expiration date.
2) Each labeling matls: Physician’s
sample. Not for sale

74
Special Labeling
Instructions: MDRP
On the label of the minimum pack for
drugs listed under Section 1 of E.O. No.
821:

75
Reproductive Health Products
PI and PIL as product information
PIL shall be written in English and
Filipino, and/or local dialect

76
Exemptions
1) Drug products manufactured for export;
2) Veterinary drug products;
3) The container or primary pack containing the product
is enclosed in a transparent covering and the
particulars which are required to be set on the label
on the container or primary pack are clearly visible
through transparent covering, the transparent
covering is exempted;
4) Products that are compounded by a pharmacist
in accordance with the individual prescription of a
medical practitioner or dentist for immediate use;

77
Exemptions
5) Investigational products;
6) Foreign donations of drug products;
7) Products that require special handling
(pre-filled syringes, cold chain); and
8) Low volume of importation
(<12,000 units per year)

78
Exemptions
1) GLE application – submitted with registration
application, except for low volume of
importation
2) Reqts: Letter – stating grounds for exemption
and sample labels; for low volume-market
forecast
3) Approval – GLE Certificate w/ validity and
number
4) Registration Number and name and address of
MAH must be reflected on the label

79
VIII. Repealing and
Separability clause
A.O. 55 s. 1988, A.O. 85 s. 1990, A.O. 99
s. 1990 and their implementing guidelines,
A.O. 109 s. 1969, A.O. 126 s. 1970, A.O. 64 s.
1989, as well as other provisions in existing
administrative issuances, bureau circulars and
memoranda inconsistent with this
Administrative Order

80

C. MANDATORY INFORMATION
FOR LABELING MATERIALS
81
Mandatory Information:
Unit Carton
1) Product Name
5) Indication(s)
6) Warning(s) (if applicable)
7) Storage condition(s)
8) Pack Size
82
Unit Carton
9) Name and Address of MAH

83
Primary Label excluding blister pack,
foil strip and small containers
1) Product Name
5) Indication(s)
6) Warning(s) (if applicable)
7) Storage condition(s)
8) Net Content
84
Primary Label excluding blister pack,
foil strip and small containers
9) Name and Address of MAH

85
Blister Packs/Foil Strips
1) Product name on each unit or every two
(2) units for multiple APIs;
2) Dosage form and strength of API(s) on each
unit or every (2) units for multiple
APIs;
3) Name and/or logo of the MAH on each unit
or every two (2) units for multiple
APIs (for unbranded products only)
86
Blister Packs/Foil Strips
4) Rx symbol on each unit or every two (2)
units for multiple APIs
5) Batch number and expiration date on every
standard blister pack/foil strip; provided
when product is not restricted to be
dispensed in quantities less than the
standard blister pack or foil strip, the
batch or lot number and expiry date – each
unit

87
Primary Label of
Small Containers
1) Product name
3) Net Content
4) Name and/or Logo of MAH
5) Rx Symbol

88
Primary Label of
Small Containers
6) Registration Number
7) Storage Condition(s)
8) Batch and/or Lot Number
9) Expiration date and Date of
Manufacture
Due consideration may be given in view of

limited space on the label.
89
Package Insert
1) Product Name
4) Product Description
6) Pharmacodynamics/kinetics
7) Indication(s)
90
Package Insert
8) Dosage and Mode/Route of
Administration
9) Contraindication(s), Precaution(s),
Warning(s) (if applicable)
10) Pregnancy and Lactation (if
applicable)
11) Interactions
91
Package Insert
12) Adverse Drug Reaction(s)
13) Overdose and Treatment
14) Storage Condition(s)
15) Dosage Forms and Packaging Available
(pack size)
16) Instructions and Special Precautions for
Handling and Disposal (if applicable)
92
Package Insert
17) Name and Address of Marketing
Authorization Holder
18) Name and Address of Manufacturer
19) Caution Statement
20) ADR Reporting Statement

93
Package Insert
22) Date of First Authorization/Renewal
of Authorization
23) Date of Revision of Package Insert

94
Patient Information Leaflet
1) Name of the Product
2) Description of the Product
3) What is in the Medicine?
4) Strength of the Medicine
5) What is this Medicine used for?
6) How much and how often should you use
this Medicine?

95
7) When should you not take this Medicine?
8) Care that should be taken when taking
this Medicine?
9) Undesirable Effects
10) What other medicine or food should be
avoided whilst taking this Medicine?

96
11) What should you do if you miss a dose?
12) Signs and Symptoms of Overdosage
13) What to do when you have taken more
than the recommended dosage?
14) How should you keep this Medicine?
15) When should you consult your doctor?

97
16) Name and address of MAH
17) Name and address of Manufacturer
18) ADR Reporting Statement
20) Date of First Authorization/Renewal
21) Date of Revision of PIL

98
D. IMPLEMENTATION
ARRANGEMENT
99
Implementation
Initial and renewal applications submitted
22 April 2016 – compliant to the new AO
Renewal applications submitted 22 April
2016 – given 2 years exhaustion
Existing products that opt to comply even
prior to renewal registration: PAC
22 April 2021: all products are compliant

100
E. DISCUSSION
101
Query 1
Please consider to include statement on
acceptability to put the dosage strength
beside the brand name in order to allow
bigger font size and style too.
FDA no longer controls the positioning of

contents and style of labels, so long as the
minimum requirement is met.

102
Query 2
Please consider to allow the ADR Reporting
statement to refer to the contact
details/website of the respective companies
instead of being in addition to the FDA
website.
This is part of PV strengthening of FDA.

103
Query 3
On MDRP, prices may change.
Manufacturers will be challenged, especially
if patients end up paying more than what is
in the MDRP.
This is an executive order issued by the

President in coordination with the DOH. DOH
is the appropriate office to address issues on
the prices stated.

104
Query 4
Does the transitory provision mean that we
can retain the present labeling format until
we apply for CPR renewal, let’s say renewal
is still 4 years from date of implementation?
Yes

105
Query 5
 With the non-specific requirement regarding the
Principal Display Panel, please clarify what will be
the guideline on the sticker labels containing the
minimum information required on the unit carton
for products approved with Generic Labeling
Exemption, i.e. International Pack, Standard Export
Packs, etc. The companies may not be able to put
sticker label on several panels.
 FDA Registration Number and Name and address of

MAH

106
Query 6
Please consider to include provision for
exception regarding non-availability of the
batch number and expiry date on a per
tablet or per unit for certain packs subject
to company application due to very limited
space.
In consideration of the dispensing practices

in the country, this is required.

107
Query 7
Please consider to delete the requirement of
date of authorization since the insert will be
included on the package wherein the carton
includes the DR Number (indicating market
authorization for the product).
This is part of the harmonization in ASEAN. If

costs are considered then make proper inventory
of your labels, or consider the date of first
authorization
108
Query 8
Please clarify whether the salt is no longer
required on the Generic Name box but
should be reflected on the Formulation
section only.
The active moiety will be reflected as the

product name; the formulation will reflect
the salt if it is the API form

109
Query 9
We propose to maintain the current
requirement on the prominence to be shown as
follows: use of outline box and generic name
with at least one font size bigger than the
brand name, regardless of the font type. This
will provide for a general reference standard
for our self-regulation.
The definition of prominence provides a clearer

description of what is larger.
110
Query 10
Clarify if the new issuance is retroactive.
[Background: Recent instance that AR was
submitted before AO effectivity but
mandated to submit AO-compliant labels
and to exhaust existing inventory]
Compliance is upon renewal. You may submit

your labels within the 1st year of the validity
of the renewed CPR (as PAC)

111
Query 11
Upon renewal, revised artworks will be
submitted to comply with the new labeling
AO, what classification will be used? PH06,
MiV-PA02, or just a notification? Is there a
payment required?
You may submit your revised labels with the

AR application. No additional fees required.

112
Query 12
 Formulation/Composition – Aside from Active
Ingredients (and alcohol content if present in the
product), are ALL Inactive ingredients also
mandatory to be reflected in the box and in the
Immediate labels? Can it just be reflected in the
Product Insert? Or the only required Inactive
ingredients to be reflected are those that can caused
hypersensitivity?
 Active ingredients, alcohol, and those that may cause

hypersensitivity reactions is required for all labels.

113
Query 13
“In addition, a statement instructing the
patient to seek medical attention
immediately....” – is this MANDATORY even
on unit carton? Is this applicable to OTC
classified products? Is this application to
GLE products?
Yes, yes, no.

114
Query 14
Can we still use the abbreviated salt forms
under the formulation/composition panel?
Yes.

115
Query 15
Can the table under storage conditions be
updated if there are changes in the ACTR for
Stability Studies? In the recently concluded
ACCSQ-PPWG it was proposed to reinstate
the 25oC.
Yes.

116
Query 16
The revised guidelines do not have
provisions for a PDP. Please clarify if
information related to Name and Address of
MAH and Manufacturer may be located on
the side or back panel.
Yes. The intention of FDA is to relax the policy

in terms of design and positioning of
contents.

117
Query 16
The revised guidelines do not have
provisions for a PDP. Please clarify if
information related to Name and Address of
MAH and Manufacturer may be located on
the side or back panel.
Yes. The intention of FDA is to relax the policy

in terms of design and positioning of
contents.

118
Query 17
There is a concern on the reconciliation of AEs
being coursed through the FDA and the
company. There is a possibility of double
reporting. If a patient opts to report only to the
FDA, will there be a follow through? Who will
call the patient for additional information,
when necessary?
The system of FDA can handle reconciliation of

these reports. FDA conducts PV so it is us who
will follow through, investigate, and implement.

119

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Republic of the Philippines

Administrative Order No. 2016-0008

Center for Drug Regulation and Research

Revised Labeling Regulation

Center for Drug Regulation and Research

Center for Drug Regulation and Research

Center for Drug Regulation and Research

Center for Drug Regulation and Research

Center for Drug Regulation and Research

Center for Drug Regulation and Research

Center for Drug Regulation and Research

Center for Drug Regulation and Research

Center for Drug Regulation and Research

Center for Drug Regulation and Research

Center for Drug Regulation and Research

Revised Labeling Regulation

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Center for Drug Regulation and Research

Center for Drug Regulation and Research

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Center for Drug Regulation and Research

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Center for Drug Regulation and Research

Revised Labeling Regulation

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Market Authorization Holder:

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Market Authorization Holder:

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1) Required for prescription products;

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Foods, Drugs, Devices, and Cosmetics

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1)Month and year is required; if

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