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Expansion of Establishment

FDA sponsor and CRO form for expansion of establoishment

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
EXPANSION OF ESTABLISHMENT

COMPANY NAME
COMPANY ADDRESS

:
:

ADDITIONAL SITE
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

No

REMARKS
CLIENT

FDA

1. Application Form
 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 owner appearing in the application form the
same with that of the DTI certificate?
 Is the address of the additional site 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
the complete address of drug establishment?

1

(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 of the additional site 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 service/s and product 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. New Location Plan
 Is the sketch submitted indicates certain landmark?
 Is the GPS Coordinates included?
4. Updated Delegation of Authority (where applicable)
 Is an updated delegation of authority attached?
 Does the new address indicated correspond to the address
indicated in the business registration certificates?
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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