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Renewal Application of LTO
FDA sponsor and CRO application form for renewal
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
SPONSOR (
) / CONTRACT RESEARCH ORGANIZATION (
)
SELF-ASSESSMENT TOOLKIT FORM
RENEWAL APPLICATION OF LICENSE TO OPERATE
COMPANY NAME
COMPANY ADDRESS
:
:
LTO NUMBER
:
VALIDITY
:
Directions:
Fill out the form by ticking the applicable column. Provide remarks on the client’s column when necessary.
Accomplish in duplicate copies.
DOCUMENTARY REQUIREMENTS:
Yes
REMARKS
No
CLIENT
1. Application Form for LTO
Is the application properly filled out?
Is it duly notarized?
Are the signatories in the application form the approving
authority and qualified person 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
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?
Is the person identified in the said document the same
person who signed the Application Form and/or Contract/
Agreement?
2. Copy of Certifications issued as a result of LTO Variation (If, any)
Are all issued certifications included?
3. Proof of Payment
Is the payment made according to the required fee?
Prepared by:
Position (Qualified Person / Owner):
Decision:
Approval
Denial
Clarification
Inspection
--- To be filled out by client: --Signature:
Date:
--- To be filled out by FDA Officer: ---
Remarks:
Evaluated by:
Date:
FDA
--- To be filled out by CDRR: --Decision:
Approval
Clarification
Evaluated by:
Remarks:
Date:
