BAI-AFSD Form No.

Republic of the Philippines

Department of Agriculture

BUREAU OF ANIMAL INDUSTRY

Visayas Avenue, Diliman, Quezon City

APPLICATION FOR REGISTRATION OF

VETERINARY DRUG AND PRODUCT

(Under R.A. 1556,R.A. 9711 and R.A. 6675)

TIN : 300000746316

Date

Name of Company/Establishment :
Office Address :
Nature of Business :
(VDAP Manufacturer/VDAP Trader/VDAP Distributor/Importer/VDAP Wholesaler/VDAP Exporter/VDAP Oulet)

Name of Manager:

Tel No. :

Fax No. :

e-mail address :

Plant/Store Address :

Tel No. :

Name of Product (Generic) :

Brand Name (if any) :
Available scientific and product evidence and experience on the Veterinary use:
(Investigational/New/Tried & Tested/Established/Pharmaceuticals as Therapeutic Innovation of Tried & Tested on Established VDAP)

No. of Active Ingredients :

(Single / Fixed dose combination / Multi-component)

Pharmacologic / Therapeutic Category :

(As specified in the PNVDF)

Source or Circumstance of VDAP Production :

(Imported finished/locally-manufactured from imported/local materials)

Brand Identification & Patent Protection of VDAP :

(Branded & Patented/Branded & Off-Patent/Unbranded & Off-Patent)

Prescribing and dispensing regulations applicable :

(OTC/Ethical or Prescription VDAP/Dangerous VDAP/VDAP requiring precaution in prescribing and dispensing)

Veterinary Medical Officer

Applicant/Authorized Representative (Print Name & Signature)

Designation

SUBSCRIBED AND SWORN to before me this ___________ day of _____________ 20 ____.

The Affiant exhibited to me his/her Community Tax Certificate No. ______________ issued at ________________
on ___________, 20 _____.
Doc No.
Page No.
Book No.
Series of

Documentary
Stamp
Notary Public

RECOMMENDING APPROVAL:

RAFVDAPCO

Region

(To be filled-up by BAI-AFSD)

BAI License to Operate No. ____________________

Valid Until _________________________________
BAI CPR No. _______________________________
Date Issued _______________________________
Valid Until _________________________________
Fee ______________________________________
Official Receipt No. __________________________
Date Issued _______________________________
Remarks: _________________________________
New

APPROVED:

Renewal

(see back pls.)

CHECKLIST OF REQUIREMENTS
FOR INITIAL/RENEWAL OF REGISTRATION OF VETERINARY DRUGS AND PRODUCT PREMIXES
one copy

1. ** Notarized letter of application from manufacturer/traders/distributor (Annex AFSD Form 3A) for Initial/Renewal of
registration or Change of Circumstances (COC)
one copy
2. * Duly Accomplished AFSD Form No. 3
one copy
3. *** Contract of Agreement/Authorization between manufacturer & distributor
one copy
4.
List of all ingredients used as a component of the product indicating the quantity and technical specification
one copy
5.
Full description of the methods used, the facilities and controls in the manufacture, processing and packaging
of the product
one copy
6.
Technical specification and physical description of the finished products
one copy
7. * Complete assay procedure for active ingredients, finished product and degradation products, if any
one copy
8. * Certificate of Analysis of the bacth/lot number of sample submitted (BAI/Recognized Laboratory)
one copy
9.
Stability studies of the product to justify claimed expiration date. (Accelerated/and or actual Stability Date
from at least three (3) elevated temperatures and actual stability)
10.
Unattached generic labels or proposed label to be used for the product with actual color and text
(In accordance with A.O. 55, S. 1988)
11. ** Duly accomplished and notarized Declaration Form
12.
Brand Name Clearance
13. * Xerox copy of valid PRC license of Veterinary Medical Officer
14.
MRL and ADI of the product (Where Applicable)
15. * Copy of latest Certificate of Product Registration (CPR) and License to Operate (LTO)**
three copies 16. * Actual Commercial label and copy of previously BAI approved for Final Printing Label
17.
Proof of payment of Registration upon approval for CPR.
CHANGES IN CIRCUMSTANCES:
1. Official letter re: change of address/owner/business name/Veterinarian/Pharmacist/Chemist/etc.
2. Surrender original CPR and approved label
3. Duly notarized Declaration Form, Form 3A and Form 3 for any change(s) in the product
4. Pertinent documents required for the amendment of product claims
ADDITIONAL REQUIREMENTS FOR IMPORTERS OF AUTHORIZED DISTRIBUTOR
FROM FOREIGN SOURCES
1.
2.

* Government Certificate of Clearance and Free Sale/Registration approval of the product from country of origin
* Government Certificate of attesting to the status of the manufacturer's competency and reliability of the
personnel and facilities
Agreement must be authenticated by the territorial Philippine Consulate in case of Exclusive Distributorship

3.
NOTE:

Items 1, 2 & 3 should be duly authenticated by territorial Philippine consulate or in the absence of the Consulate,
any equivalent regulatory government Agency.

SCHEDULE OF FEES
Upon approval of application for registration of a veterinary drug and product, the following fees (non-refundable) shall be charged in
full for entire coverage of registration
Initial Registration:
(

Unbranded Generic

1,200.00 for 2 years + cost of

Laboratory Analysis

Branded Generic

2,400.00 for 2 years - cost of

Laboratory Analysis

Renewal Registration:
P 1,800.00 for 5 years + cost of Laboratory Analysis

Inspection Fee:
An inspection fee of P0.25 per kilogram an P1.00 per liter for premix additives and supplements that are manufactured locally
or imported shall be charged monthly on the basis of total volume of VDAP manufactured or imported. Please refer to the Department
of Agriculture Administrative Order No. 33 Series of 2000 and Department of Agriculture No. 05 Series of 2004 for the
appropriate fees.

* To be submitted upon renewal of registration

** Change of Circumstances (COC)