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Change of Activity

FDA drug distributor form for change of activity

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Department of Health
FOOD AND DRUG ADMINISTRATION

CENTER FOR DRUG REGULATION AND RESEARCH
DRUG IMPORTER (

) / EXPORTER (

) / WHOLESALER (

)

SELF-ASSESSMENT TOOLKIT FORM
CHANGE OF ACTIVITY

COMPANY NAME
COMPANY ADDRESS
OWNER

:
:
:

ADDITIONAL/CHANGED :
ACTIVITY
INITIALLY-APPROVED
:
ACTIVITY
LTO NUMBER
:
VALIDITY
:
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.
REMARKS

DOCUMENTARY REQUIREMENTS:

Yes

No

CLIENT

FDA

1. Application Form
Is the application 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 the board resolution or Secretary’s Certificate notarized
and clearly identify the person authorized to sign for and in
behalf of the owner or corporation?




2. Contract Agreements to Prove Activity
 Is the relevant contract for the additional/change of activity
(e.g., export agreement for Distributor Importer applying for
additional/change exportation activity) attached?
 Is the attached contract valid, duly notarized/authenticated?
 Is the relevant attachments/annexes included?

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3. 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?
Note: If the following is/are not submitted in the initial application, the said document/s shall be attached:
 Risk Management Plan (RMP) or commitment letter while the official RMP framework from FDA is not yet issued
 GPS Coordinates
NOTE: ADDITIONAL DOCUMENTS MAY BE REQUIRED TO BE SUBMITTED AS DEEMED NECESSARY.
--- To be filled out by client: --Prepared by:
Signature:
Position (Pharmacist / Owner):
Date:
--- To be filled out by RFO: --Remarks:
Decision:
Approval
Denial
Clarification
Inspection
Evaluated by:
Date:

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

Remarks:

Date:

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