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Change of Business Name
FDA drug manufacturer form for change of business name
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 MANUFACTURER (
) / PACKER (
) / REPACKER (
) TRADER (
)
SELF-ASSESSMENT TOOLKIT FORM
CHANGE OF BUSINESS NAME
COMPANY NAME
COMPANY ADDRESS
:
:
NEW BUSINESS NAME
:
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
Is the integrated application form 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 there a board resolution or notarized Secretary’s
Certificate clearly identifying the person authorized to sign
for and in behalf of the owner or corporation submitted?
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 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 the complete
address of drug establishment?
(b) For corporation, partnership and other juridical person,
Certificate of Registration issued by the Securities and
1
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 and product applied for LTO indicated
in the Articles of Incorporation (Article II)?
(c) For cooperative, Certificate of Registration issued by
the Cooperative Development Authority and the
approved by-laws
Is the business name applied for LTO the same with that of
the CDA registration certificate?
Is the address indicated in the CDA the same with the address
of the establishment applied for LTO?
Is the type of activity and product applied for LTO indicated
in the approved articles and by-laws of the cooperative?
(d) For government-owned or controlled corporation
Is there a copy of the law creating the same? (if with original
charter)
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: --Decision:
Remarks:
Approval
Denial
Clarification
Inspection
Evaluated by:
Date:
--- To be filled out by CDRR: --Decision:
Approval
Clarification
Evaluated by:
Remarks:
Date:
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