Page 1 of 4 
  
 
 
 
ANNEX B  
 
 NOTIFICATION FORM FOR MINOR VARIATION/S OF REGISTERED  
PHARMACEUTICAL PRODUCT  
 
Date:         DOCUMENT TRACKING NUMBER (DTN)  
       
FOOD AND DRUG ADMINISTRATION  TO BE FILLED OUT BY FDA  
Civic Drive, Filinvest Corporate City  Received by:        
Alabang, Muntinlupa City  Signature:        
 Date:        
 PAYMENT DETAILS  
 Amount Paid:        
 OR No.:        
 OR Date Issued:        
Sir/Madam:  
 In accordance with Administrative Order No. 2013 -0021 and related issuances, we wish to apply and 
notify FDA of our intention to make Minor Variation/s to our pharmaceutical product described below:  
 
PRODUCT PARTICULARS  
Details should be consistent with the current CPR/CLIDP.  
Generic Name        
Dosage Strength and Form        
Brand Name        
 
Approved Shelf -life       
Storage Condition        
Packaging/Presentation        
 
 
FDA Registration No.         Validity         
Registration Status          State the validity or the DTN of the renewal application, 
if the CPR/CLIDP has not yet been renewed  
 
COMPANY PARTICULARS  
Details should be consistent with the current CPR/CLIDP. Complete name/s and address/es of the involved establishment/s 
should be reflected.  
Manufacturer        
       
Trader        
       
Importer        
       
Distributor        
       
Packer/Repacker        
       
Republic of the Philippines  
Department of Health  
FOOD  AND  DRUG  ADMINISTRATION  
 
 
Page 2 of 4 
  
DTN  
      
Received by:        
 
POST -APPROVAL CHANGES PARTICULARS  
 
Table of Changes  
 
Current   
Proposed Changes   
Specific Type of Variation  
For BMiV -N17, indicate the original 
variation code applied for the PCPR, 
e.g. BMiV -N17 (BMaV -15) 
                  
                  
                  
 
*** NOTHING FOLLOWS ***  
  
Page 3 of 4 
  
DTN  
      
Received by:        
 
DECLARATION  
 
In support of our notification, 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 
Notification Form for Minor Variation/s of Registered Pharmaceutical Product (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 notification form meets all the legal 
requirements, and conforms to existing standards and specification requirements applicable to the said 
product.  
3. All conditions for the variations have been fulfilled and all required supporting documents are submitted.  
4. The particulars given in this notification are true and all data and information of relevance in relation to the 
notification have been supplied and that the documents enclosed are authentic or true copies.  
5. I agree that the acknowledgement of this notification shall not preclude the Food and Drug Administration 
(FDA) in imposing appropriate regulatory actions in the event that there i s/are outright negligence on the 
conditions for minor variation – notification and explicit misdeclaration of the applied changes as 
notification; lacking and deficient documentary requirements as stipulated in existing policies on Post -
Approval Changes; s ubsequent 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 samples of the identified pharmaceutical product col lected 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 further distributing the identified 
pharmaceutical p roduct 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) 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 necessary.  
b) Notify FDA of any reported adverse drug reactions consistent wit h the requirements of 
pharmacovigilance.  
c) Respond to and cooperate fully with Food -Drug Regulation Officers (FDROs) with regard to any 
subsequent post -marketing activity initiated by FDA.  
d) 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 notification, at the manufacturing level.  
8. I understand that our company or establishment cannot place reliance on the acceptance of the notification 
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.  
9. There is/are no other change/s made to/proposed for the d rug product aside from what is/are specified in 
the Post -Approval Changes Particulars of this Notification Form.Page 4 of 4 
  
DTN  
      
Received by:        
 
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 me that 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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