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Additional Activity

FDA drugstore form for additional activity

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

CENTER FOR DRUG REGULATION AND RESEARCH
DRUGSTORE (

) / HOSPITAL PHARMACY (

) / INSTITUTIONAL PHARMACY (

)

SELF-ASSESSMENT TOOLKIT FORM
ADDITIONAL ACTIVITY

COMPANY NAME
COMPANY ADDRESS
OWNER

:
:
:

ACTIVITY TO BE
ADDED

:

LTO NUMBER
VALIDITY

:
:

NON-STERILE OMPOUNDING
STERILE COMPOUNDING
MOBILE PHARMACY

ONLINE ORDERING AND DELIVERY

Directions:
Fill out the form by ticking the applicable box. Provide remarks on the client’s column when necessary.
Submit in Portable Document Format (pdf) and word format duly signed by the pharmacist/owner.

DOCUMENTARY REQUIREMENTS:




REMARKS
Yes

No

CLIENT

FDA

1. Application Form
Is the integrated application form properly filled out?
Is it duly notarized?
Are the signatories in the application form the authorized
persons as required under the following circumstances?
(a) If single proprietorship – the owner as registered in
DTI (unless there is a different authorized person)
(b) If partnership/corporation – one of the incorporators
or authorized person as indicated in the board
resolution or Secretary’s Certificate
(c) If cooperative – authorized person indicated in the
board resolution or Secretary’s Certificate of the
cooperative

If the signatory is not the owner or one of the incorporators,
as the case may be:


Is there a board resolution or notarized Secretary’s
Certificate clearly identifying the person authorized to
sign for and in behalf of the owner or corporation
submitted?
For government-owned or controlled corporation:



Is there an Order (or equivalent document) identifying
the person authorized to sign for and in behalf of the
establishment submitted?

2. Additional Credentials of Pharmacist
 Does the certification of training correspond to the
activity to be added?
 Does the certification reflect the name of the pharmacist?

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3. Documents Related to Activity
 Is there a proof of validation included?
4. Proof of Payment
 Is the payment made according to the required fee?
 Is there a scanned copy of proof of payment (e.g FDA
official receipt, Landbank On-coll validated slip )
submitted?
--- To be filled out by client: --Prepared by:
Signature:
Position (Pharmacist / Owner):
Date:
--- To be filled out by RFO: --Decision:
Remarks:
Approval
Denial
Clarification
Inspection
Evaluated by:
Date:

--- To be filled out by CDRR: --Decision:
Approval
Clarification
Evaluated by:

Remarks:

Date:

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