ANNEX A  
 
Letter of Request for Post -approval Change/s  
 
DTN        
 
Date:                
 
 
FOOD AND DRUG ADMINISTRATION  
Civic Drive, Filinvest Corporate City  
Alabang, Muntinlupa City  
 
 
Attention:  Licensing and Registration Division  
Center for Drug Regulation and Research  
 
 
Sir/Madam,  
 
We would like to submit our application for Post -approval Change/s, (type of Post 
Approval Change as per PVGB)  for the following product/s:  
 
Product 
Name/Strength 
and Form  CPR 
Validity/Drug 
Registration 
Number  Current  Proposed Change/s  Classification/ 
Specific Type 
of PAC/s  
      
       
                   
                  
                  
 
We, (company name) , declare that there is/are no other change/s to the drug product 
registration aside from what is/are specified above.  
 
For your approval.  
 
 
Very truly yours,  
 
 
 
(Company representative name and signature)  
(Position)  
 
 
 
 
  DECLARATION  
 
In support of our post -approval change/s application, I, the undersigned, hereby declare under oath 
that: 
 
1. I am duly authorized to bind the establishment I represent pursuant to the authority attached to this 
Letter of Request for Post -Approval Change/s (Board Resolution in case of corporation and Special 
Power of Attorney in all other cases both of which should be duly notarized).  
2. On behalf of my company, the pharmaceutical product identified in the letter of request meets all the 
legal requirements and conforms to existing standards and specification requirements applicable to the 
said product, and that the propose d change/s has/have been checked in reference to the currently 
approved data in the system.  
3. All conditions for the post -approval changes have been fulfilled and all required supporting documents 
are submitted.  
4. The particulars given in this application are true and all data and information of relevance in relation 
to the request have been supplied and that the documents enclosed are authentic or true copies.  
5. I agree that the approval of the variation/s shall not preclude the Food and Drug Administration (FDA ) 
in imposing appropriate regulatory actions in the event that there is/are outright negligence on the 
conditions for variation and explicit misdeclaration of the applied changes as variation; lacking and 
deficient documentary requirements as stipulated in  existing policies on Post -Approval Changes; 
subsequent findings of misrepresentation in any of the data indicated in the required documents or any 
of the said documents is subsequently found to be falsified or fraudulently filed; and/or in case the 
sample s of the identified pharmaceutical product collected through post -marketing surveillance shall 
be found not to conform to the product’s registered specifications or approved labeling.  
6. The company I represent shall automatically cease and desist from furthe r distributing the identified 
pharmaceutical product subject of revocation upon receipt of the notice of revocation and pending any 
administrative proceeding until further notice from FDA.  
7. I, or my company undertake to:  
a. All the conditions.  
b. Ensure the identified pharmaceutical product’s technical and safety information is made readily 
available to FDA anytime when requested, and to keep records of the distribution of the products 
for inspection, product recall, and other purposes that may be deemed nece ssary.  
c. Notify FDA of any reported adverse drug reactions consistent with the requirements of 
pharmacovigilance.  
d. Respond to and cooperate fully with Food -Drug Regulation Officers (FDROs) regarding any 
subsequent post -marketing activity initiated by FDA.  
e. Exhaust the remaining stocks of labeling materials and products  bearing the old product 
information up to a maximum of one (1) year from the date of receipt of the certification, at the 
manufacturing level.  
8. I understand that our company or establishment canno t place reliance on the acceptance of the post -
approval change by FDA in any legal proceedings concerning the above product, in the event that the 
identified product has failed to conform to any standards or specifications previously declared to FDA.   HEAD  OF REGULATORY AFFAIRS OFFICE  COMPANY PHARMACIST  
  
Signature:        Signature:        
Name:        Name:        
Designation:        Designation:        
Date:        Date:        
 
 
SUBSCRIBED AND SWORN TO BEFORE ME this       personally appeared the following:  
 
Name  Residence Certificate  Date Issued  Place Issued  
      
 
                   
      
 
                   
 
Known to me and to me known to be the same persons who executed the foregoing instrument and 
they acknowledged to met hat the same is their free and voluntary act and deed.  
 
WITNESS MY HAND AND SEAL on the date and place first above written.  
 
 
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