Republic of the PhilippinesDepartment of Agriculture

BUREAU OF ANIMAL INDUSTRY

Visayas Avenue, Diliman Quezon City
TIN: 300000746316

APPLICATION FOR LICENSING OF VETERINARY DRUG

AND PRODUCT ESTABLISHMENT Latest
Under R.A. 3720, known as the Food, Drugs and Devices and Cosmetics Act; R.A. 9711 known as "Food and Drug Administration Act of 1"x1" ID Picture
2009", RA 6675 , known as "Generics Act of 1988;" R.A. 10611, the "Food Safety Act of 2013", and RA 1556, otherwise Applicant
known as the "Livestock and Poultry Feeds Act".

Date:
Name of Establishment :
Office Address :
Telephone No : Mobile No: E-mail address :
Plant Address :
Warehouse Address :
Nature of Business : Business Organization:
(Please see at the back) (Please see at the back)
Name of Chemist : PRC ID No.: Valid Until :
Name of Veterinarian : PRC ID No.: Valid Until :
Name of Pharmacist : PRC ID No.: Valid Until :
Membership to any Veterinary Drug Association, Yes, please specify No
Name of Association:

Signature Over Printed Name of Applicant or Authorized Representative

Designation

SUBSCRIBED AND SWORN to before me this day of , 20

The Affiant exhibited to mehis/her Government issued ID (PRC, Driver's license, Voters ID, TIN, Passport, UMID) No.
on valid until 20 .

Doc No.
Page No. Doc Stamp
Book No.
Notary Public

RAFVDABCO RECOMMENDING APPROVAL:

Region

(To be Filled-up by BAI-AFVDBCD Staff/Deputized AFVDABCO)

License nto Operate No. APPROVED:
Valid Until:
Fee:
Official Receipt No.
Date Issued:
Remarks:

New Renewal CIC

RF FVDB-02 Application for Licensing of Veterinary Drug and Product EstablishmentsRevision No. 02 September 19, 2019
 REQUIREMENTS FOR THE LICENSING OF VETERINARY DRUG AND PRODUCT (VDAP) ESTABLISHMENT
General Requirements:
*1. Duly accomplished and notarized Application Form # RF FVDB-02. For items not applicable, please indicate Not Applicable or NA.
2. For business organization: (select only what is applicable)
a. For Sole Proprietorship: Photocopy of Registration from the Department of Trade and Industry (DTI);
b. For Corporations: Photocopy of Registration and Articles of Incorporation and By-Laws from the Securities and Exchange Commission (SEC);
c. For Cooperatives: Photocopy of Registration from the Cooperative Development Authority (CDA);
*3. Contract of Lease of the space (if the applicant does not own it) / Proof of ownership of the building occupied; and
4. Reference Books and Documents:
a. Philippine National Veterinary Formulary (PNVF)
b. Philippine Veterinary Drug Index
c. RA 3720, otherwise known as the Foods,Drugs and Devices and Cosmetics as amended and relevant
Implementing Rules and Regulations (IRR)
d.RA 6675, the Generics Act of 1988 and relevant IRR
e. RA 5921, Pharmacy Law, as amended and relevant IRR
f. RA 3101, An Act authorizing the Director of Animal Industry to promulgate regulation for the preparation, sale,traffic in and
shipment, and importation of viruses, serum, toxins, or analogue products used for the treatment of domestic animals and relevant IRR.
g. RA 1071, An Act to regulate the sale of veterinary biologics and medicinal preparation and relevant IRR.
h. RA 1556, Livestock and Poultry Feeds Act and relevant IRR.
5. Location Map;
*6. List of products to be manufactured/distributed with Generic or Brand Names;
*7. Conduct of Inspection (Copy of Inspection and Evaluation Report to be attached by the Inspector);
*8. Photocopy of Business/Mayor's Permit for the current year.
*9. Notarized Joint Affidavit of Undertaking between the duly-licensed Veterinarian and Owner or General Manager,
with Photocopy of valid PRC License and PTR of Veterinarian;
*10. Certificate of Attendance from orientation seminar on Licensing of Veterinary Drug and Product Establishments.
Additional Requirements:
A. VDAP MANUFACTURER

*1. Photocopy of Environmental Compliance Certificate (ECC) from the Environmental Management Bureau (EMB) or Permit to Operate (PTO) and
from the Laguna Lake Development Authority (LLDA). For plants outside Metro Manila, a corresponding valid PTO issued by the Department of
Environment Natural Resources (DENR) Provincial Office (PENRO);
*2. Certificate of Good Manufacturing Practice/HACCP or equivalent certificate related to safety and quality of the product issued from country of origin (if applicable);
*3. For Manufacturers contracting the services of an independent Quality Control Laboratory, photocopy of valid BAI-Laboratory Recognition Certificate and
Memorandum of Agreement (MOA) between the concerned parties with photocopy of valid PRC ID and PTR of Chemist.
B. VDAP TRADER:
*1. Photocopy of Environmental Compliance Certificate (ECC) from the Environmental Management Bureau (EMB) or Permit to Operate (PTO) and
from the Laguna Lake Development Authority (LLDA). For plants outside Metro Manila, a corresponding valid PTO issued by the Department of
Environment Natural Resources (DENR) Provincial Office (PENRO);
*2. For Trader contracting the services of an independent Quality Control Laboratory, photocopy of valid BAI-Laboratory Recognition Certificate and
Memorandum of Agreement (MOA) between the concerned parties with photocopy of valid PRC ID and PTR of Chemist.
C. VDAP DISTRIBUTOR:
VDAP Distributor/Importer
*1. Certificate of Good Manufacturing Practice/HACCP or equivalent certificate related to safety and quality of the product issued from country of origin
*2. List of foreign manufacturers, suppliers or distributors.
VDAP Distributor/Exporter
*1. A valid contract with FDA/BAI licensed manufacturer in addition to other requirements set by other competent authorities.
VDAP Distributor/Wholesaler
*1. A valid Contract of Agreement with BAI Licensed VDAP Manufacturer/VDAP Importer;
*2. Complete list of products to be sold with their corresponding product registration numbers and expiry dates.
D. VDAP OUTLET:
*1. Complete list of products to be sold with corresponding product registration numbers and validity of CPR.
CHANGE IN CIRCUMSTANCES (CIC):
1. Official letter requesting change in address/ownership/business name/veterinarian/pharmacist/chemist, etc.
2. Application form RF FVDB-02 reflecting required change/s;
3. Surrender Original copy of LTO;
4. Mayor's Permit in case of change of address or business name or ownership;
5. SEC or DTI in case of change of address or business name or ownership;
6. Deed of Sale/Transfer of Rights in case of change of ownership;
7. Notarized Joint Affidavit of Undertaking between the duly-licensed Veterinarian and Owner or General Manager, Photocopy of valid PRC License of Veterinarian; and
8. Payment of Fee.
**F. SCHEDULE OF FEES

Establishment Initial Renewal

VDAPM P 6,000.00 P 12,000.00 (2 years)

VDAPT 3,600.00 7,200.00 (2 years)
VDAPD/Importer >
VDAPD/Exporter > 2,400.00 4,800.00 (2 years)
VDAPD/Wholesaler >
VDAP Outlet 240.00 P 480.00 (2 years)
CIC 100.00

Surcharge: An additional 50% of the amount due shall be levied on every expired LTO.

All Applications together with required documents should be submitted in color-coded folders with ear tags
* To be submitted upon renewal
** Fees to be paid upon satisfactory compliance of all general and additional requirements. Fees are non-refundable and shall be charged in full for the entire validity of LTO.

RF FVDB-02 Application for Licensing of Veterinary Drug and Product (VDAP) Establishment
Revision No. 02
September 19, 2019