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Renewal Application of LTO

FDA drug distributor form for renewal application form of LTO

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 IMPORTER (

) / EXPORTER (

) / WHOLESALER (

)

SELF-ASSESSMENT TOOLKIT FORM

REGULAR RENEWAL (
) AUTOMATIC RENEWAL ( ) APPLICATION OF LICENSE TO OPERATE
COMPANY NAME
:
COMPANY ADDRESS
:
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

No

REMARKS
CLIENT

FDA

1. Application Form for LTO
 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. Copy of Certifications issued as a result of LTO Variation
 Are all issued certifications included?
Note: Scanned copy of latest LTO is requested to be attached
with copy of official receipt of previous renewal application.
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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