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Change of Ownership

FDA sponsor and CRO form for change of ownership

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
CHANGE OF OWNERSHIP

COMPANY NAME
COMPANY ADDRESS

:
:

NAME OF PREVIOUS
OWNER
NAME OF NEW OWNER

:
:

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

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
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. Proof of Business Name Registration
(a) For single proprietorship, Certificate of Business
Registration issued by the Department of Trade and
Industry (DTI)
 Is the business name applied for LTO the same with
that of DTI registration certificate?
 Is the DTI certificate still valid?
 Is the new owner appearing in the application form the
same with that of the DTI certificate?
 Is the address of the establishment applying for LTO
within the territorial coverage? If the business address
indicated in DTI is different from the exact address as
declared in the application form, is there a clear copy of
Business/Mayor’s Permit or Barangay clearance indicating

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the complete address of drug establishment?
(b) For corporation, partnership and other juridical person,
Certificate of Registration issued by the Securities and
Exchange Commission (SEC) and Articles of
Incorporation
 Is the business name applied for LTO the same with
that of the SEC registration certificate? If the company uses
another business name style different from its corporate
name, is an amended SEC registration reflecting the same
submitted?
 Is the address indicated in the SEC the same with the
address of the establishment applied for LTO?
o If the address in SEC is still occupied but the business
operation applied for LTO is located in a separate area,
is a clear scanned copy of Business /Mayor’s Permit or
Barangay clearance indicating the complete address of
drug establishment submitted?
o If the address in SEC is no longer occupied, is an
amended SEC registration reflecting the current
business address submitted?
 Is the type of activity or services and products applied
for LTO indicated in the Articles of Incorporation (Article
II)?
(c) For government-owned or controlled corporation
 Is there a copy of the law creating the same? (if with
original charter)
3.



Deed of sale or transfer of rights
Is it duly notarized?
Are the previous and new owners correctly identified?

4.



Updated Delegation of Authority (where applicable)
Is an updated delegation of authority attached?
Does the name indicated correspond to the new owner?

5. Proof of Payment
 Is the payment made according to the required fee?
Prepared by:
Position (Qualified Person / Owner):
Decision:
Approval
Denial
Clarification
Inspection

Remarks:

Decision:
Approval
Clarification
Evaluated by:

--- To be filled out by client: --Signature:
Date:
--- To be filled out by FDA Officer: ---

Remarks:

Evaluated by:

Date:

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

Date:

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