Scribd
Upload
293 views2 pages

7 - DS SATK - Zonal Change in Address 1.2

1. The document is a self-assessment toolkit form from the Philippines Department of Health Food and Drug Administration for pharmacies to apply for a zonal change of address. 2. The form requires the pharmacy to provide details of the new and old addresses, ownership, license information, and activities. It also checks that the proper documentation is included like a signed application, proof of the zonal change from the local municipality, and proof of payment. 3. The completed form is submitted to the FDA who will evaluate it and note their decision and any remarks, then pass it to the Center for Drug Regulation and Research for final review and approval or denial of the zonal change.

Uploaded by

MCBI Auditor
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
293 views2 pages

7 - DS SATK - Zonal Change in Address 1.2

1. The document is a self-assessment toolkit form from the Philippines Department of Health Food and Drug Administration for pharmacies to apply for a zonal change of address. 2. The form requires the pharmacy to provide details of the new and old addresses, ownership, license information, and activities. It also checks that the proper documentation is included like a signed application, proof of the zonal change from the local municipality, and proof of payment. 3. The completed form is submitted to the FDA who will evaluate it and note their decision and any remarks, then pass it to the Center for Drug Regulation and Research for final review and approval or denial of the zonal change.

Uploaded by

MCBI Auditor
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
You are on page 1/ 2

Republic of the Philippines

Department of Health
FOOD AND DRUG ADMINISTRATION

CENTER FOR DRUG REGULATION AND RESEARCH


DRUGSTORE ( ) / HOSPITAL PHARMACY ( ) / INSTITUTIONAL PHARMACY ( )
SELF-ASSESSMENT TOOLKIT FORM
ZONAL CHANGE IN ADDRESS
COMPANY NAME :      
COMPANY ADDRESS :      

NEW ADDRESS :      


OWNER :      
LTO NUMBER :      
VALIDITY :      
ACTIVITY : RETAILING NON-STERILE OMPOUNDING

STERILE COMPOUNDING ONLINE ORDERING AND DELIVERY

MOBILE PHARMACY
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 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?
For government-owned or controlled corporation:
 Is there an Order (or equivalent document) identifying the
person authorized to sign for and in behalf of the            
establishment submitted?

2. Document Issued by Local Municipality as Proof of Zonal Change


 Is the document issued by the local municipality reflects the
           
zonal change?
 Is the document duly signed by the incumbent local official
           
or its authorized signatory?

1
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 Date:
by:            

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


Decision: Remarks:      
Approval
Clarification
Evaluated by: Date:
           

You might also like