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Additional Production Line
FDA drug manufacturer form for additional product line
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
DRUG MANUFACTURER (
) / PACKER (
) / REPACKER (
) TRADER (
)
SELF-ASSESSMENT TOOLKIT FORM
ADDITIONAL PRODUCT LINE
COMPANY NAME
COMPANY ADDRESS
:
:
ADDED PRODUCT LINE
:
OWNER
:
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.
DOCUMENTARY REQUIREMENTS:
Yes
REMARKS
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?
2. Updated Site Master File
Is an updated Site Master File providing sections for the new
product line included?
Is it duly approved by the qualified personnel?
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: --Decision:
Approval
Denial
Remarks:
Clarification
Inspection
Evaluated by:
Decision:
Approval
Clarification
Evaluated by:
Date:
Remarks:
--- To be filled out by CDRR: ---
Date:
