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Joint Affidavit of Undertaking

FDA medical device registration affidavit for joint undertaking

Your Browser Doesn't Support Canvas. Showing the Text Content of the PDF Instead: Republic of the Philippines
Department of Health
FOOD AND DRUG ADMINISTRATION
Filinvest Corporate City
Alabang, City of Muntinlupa

JOINT AFFIDAVIT OF UNDERTAKING
ANNEX D
_____________________________________________

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Picture
(Pharmacist)

(PRC Registered Name of Authorized Person)
________________________ ________________
(Maiden or Married Name, if different from above)

Profession : ________________(Pharmacist/Allied Health Science Profession)
PRC Registration No.: _______________ Issued on _______ Validity: ________
PTR NO.: _________________________ Issued on: ___________
of legal age, single/married, and a resident of _____________________________________________________________and
(Complete Address)

____________________________________________ of __________________________________________ located at
(Name of Owner/Incorporator/Authorized representative of Establishment)

(Exact Business Name)

______________________________________________________________________________ of legal age and a resident
(Complete Address of Establishment)

of __________________________________________________________________________ after having been sworn in
(Complete Address of Owner/Incorporator/Authorized representative)

accordance with law hereby declare:
That we are fully aware of the provisions of the Pharmacy Law or other Allied Health Science regulations, Food and Drug
Administration Act of 2009, ASEAN Cosmetic Directive and other pertinent FDA laws, rules and regulations;
That we are aware of the specific requirements that the operation of a cosmetic establishment shall be under the PERSONAL
SUPERVISION of the Authorized Person, the business hours being from _________A.M. to ________P.M.;
That we agree to change the business name if there is already a validly registered name similar to our business name;
That we shall display our approved License to Operate and Authorized Person’s board certificate in a conspicuous place in
our establishment;
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 business name, change of ownership, change of Authorized Person and
change in cosmetic products;
That, the Authorized person is responsible for any adverse events, complaints, product returns and recalls if any and
subsequently notifies the Food and Drug Administration;
That the Authorized Person is not and will not in any way be connected with any health product regulated or similar
establishment/outlet;
That the owner and authorized person undertake to be jointly liable for any violation committed relating to the operation of a
cosmetic establishment.
WITNESS WHEREOF, we hereunto affix our signature this _______ day of ______________20___.
___________________________________
OWNER
Res. Cert. No.:_______________________
Issued on ______ at __________________

_______________________________________
AUTHORIZED PERSON
Res. Cert. No.: ___________________________
Issued on ________at _____________________

VERIFICATION
The Owner and Authorized Person after having sworn in accordance with the law, hereby states that:
(1) He / She is the owner and authorized person in the above entitled joint affidavit of undertaking;
(2) Both the undersigned has caused the preparation of the said joint affidavit of undertaking and
has read and understood the contents thereof; and
(3) The allegations are true and correct to their knowledge.
 
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