FOOD AND DRUG ADMINISTRATION

CENTER FOR DEVICE REGULATION, RADIATION HEALTH AND RESEARCH

LICENSING and REGISTRATION DIVISION

JOINT AFFIDAVIT OF UNDERTAKING

Document No.:

011-004-L-02D

Revision No.

Date Effective:

6 August 2012

Page:

1 of 1

JOINT AFFIDAVIT OF UNDERTAKING

______________________________
(PRC Registered Name)

PHARMACIST-IN-CHARGE
With PRC Registration No. _______________
Issued on_______________________________
PTR NO. _______________________________

______________________________________
(Maiden or Maiden Name different from above)
of legal age, single/married, and a resident of __________________________________ and__________
_____________________________________________________________________________________
owner of____________________________________________________________________________
(Medical Device Establishment)
located at _______________________________________________________________ of legal age and
resident of_________________________________________________ after having been sworn in
accordance with law, hereby declare:
FIRST - That we are fully aware of the provisions of the Pharmacy Law, the Foods, Drugs, Devices, and
Cosmetics Act, the Generics Act of 1988, that we are aware of the specific requirements that the Operation
of______________________________________________________________________________shall be
under the IMMEDIATE AND PERSONAL SUPERVISION of the Pharmacist-In-Charge, the business
hours being from _______AM to ________ PM;
SECOND that we agree to change the business name if there is already a validly registered name similar
to our business name;
THIRD that we shall display our approved License to Operate (LTO) in a conspicuous place of our
establishments;
FOURTH - that we shall notify FDA in case of any change(s) in the circumstances of our application for a
License to Operate, including but not limited to change(s) of location, change of ownership, change of
pharmacist-in-charge, and change in medical device products;
FIFTH and that I, the pharmacist-in-charge, am not and will not be in any way connected with any drug
or similar establishment/outlet;
WE execute this Joint Affidavit of Undertaking to confirm the truth of our declaration and our awareness
of thefore going duties and responsibilities among others.
WITNESS WHEREOF, WE hereunto affix our signature this _________________day of
_____________ 20 _______..
__________________________________
___________________________________
OWNER
PHARMACIST
Res. Cert. No. ______________________
Res. Cert. No. ________________________
Issued on __________________________
Issued on ___________________________
at _______________________________
at _________________________________
SUBSCRIBED AND SWORN TO ME THIS _____________ day of _______________20 _______.
____________________________
NOTARY PUBLIC
Until December 31, 20