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RONPD SATK Form Expansion of Establishment 1.3

This document is a self-assessment form from the Philippines Department of Health Food and Drug Administration for companies seeking to expand an existing retail outlet for non-prescription drugs. The form requires the company to provide details of the additional site and submit documentation like a properly filled application form, proof of ownership of the new site, and proof of paying the required fee. The company must fill out the form, sign it, and submit it along with the required documents for review by the Retail Field Office and Center for Drug Regulation and Research who will decide whether to approve or deny the expansion.

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99 views

RONPD SATK Form Expansion of Establishment 1.3

This document is a self-assessment form from the Philippines Department of Health Food and Drug Administration for companies seeking to expand an existing retail outlet for non-prescription drugs. The form requires the company to provide details of the additional site and submit documentation like a properly filled application form, proof of ownership of the new site, and proof of paying the required fee. The company must fill out the form, sign it, and submit it along with the required documents for review by the Retail Field Office and Center for Drug Regulation and Research who will decide whether to approve or deny the expansion.

Uploaded by

Arden
Copyright
© © All Rights Reserved
We take content rights seriously. If you suspect this is your content, claim it here.
Available Formats
Download as DOC, PDF, TXT or read online on Scribd
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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
EXPANSION OF ESTABLISHMENT
COMPANY NAME :      
COMPANY ADDRESS :      
ADDITIONAL SITE :
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.
REMARKS
DOCUMENTARY REQUIREMENTS: Yes No
CLIENT FDA
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 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?
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?

2. Proof of Ownership
 Is the proof of ownership (e.g., contract of lease/sub-lease,            
ownership title, etc) attached?
 Does it indicate the name of the applicant and address or            
space leased/owned?
 Is it valid and duly notarized?            

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?
--- 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: Remarks:      
Approval
Clarification
Evaluated by: Date:
           

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