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Renewal Application of LTO

FDA renewal form of LTO for RONPD

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
RETAIL OUTLET FOR NON-PRESCRIPTION DRUGS
SELF-ASSESSMENT TOOLKIT FORM
AUTOMATIC RENEWAL (
APPLICATION OF LICENSE TO OPERATE

REGULAR RENEWAL (
)
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

1. Application Form
 Is the integrated application form properly filled out?
 Is it duly notarized?
 Are the signatories of 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
and/or Secretary’s Certificate
(c) If cooperative – authorized person indicated in the
board resolution and/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 and/or Secretary’s Certificate
notarized and clearly identify the person authorized to sign
for and in behalf of the owner or corporation?
For government-owned establishments:
 Is there an Order (or equivalent document) identifying the
person authorized to sign for and in behalf of the
establishment submitted?
 Is the PRC ID of the pharmacist still valid?
(Note: Please attach copy of PRC ID)
2. Copy of Certifications issued as a result of LTO Variation
 Are all issued certifications included?
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?

No

REMARKS
CLIENT

FDA

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

Prepared by:
Position (Pharmacist / Owner):
Decision:
Approval
Denial
Clarification
Inspection

--- To be filled out by client: --Signature:
Date:
--- To be filled out by RFO: ---

Remarks:

Evaluated by:

Date:
--- To be filled out by CDRR: ---

Decision:
Approval
Clarification
Evaluated by:

Remarks:

Date:
 
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