(NAR) VOL. III NO. 4 / OCTOBER - DECEMBER 1992
2.1.1.1 | A standard petition form containing among others the name, age, citizenship, and a passport-size picture (5 x 5 cm) of the petitioner and other pertinent circumstances pertaining to the proposed veterinary drug and product establishment including the place where it is to be established. | ||
2.1.1.2 | Proof of registration as an establishment, i.e.: | ||
a) For single proprietorship; an authenticated photocopy of the Certificate of Business Name Registration issued by the Bureau of Domestic Trade (BDT) of the Department of Trade and Industry. | |||
b) For partnerships, corporations and other juridical persons, authenticated photocopies of the Certificate of Registration issued by the Securities and Exchange Commission (SEC) and the Articles of Incorporation or Partnership. | |||
2.1.1.3 | A valid Certificate of Registration of the establishment’s Filipino Veterinarian issued by the Professional Regulation Commission (PRC). | ||
2.1.1.4 | A valid Certificate of Registration of the establishment’s Filipino Pharmacist issued by the Professional Regulation Commission (PRC). | ||
2.1.1.5 | A valid credential of the establishment’s Filipino Microbiologist in case of veterinary biological manufacturer and trader. | ||
2.1.1.6 | A certificate of Attendance at a BFAD/BAI sponsored/accredited Seminar on Licensing of Veterinary Drug and Product Establishments; | ||
2.1.1.7 | An affidavit of undertaking providing that the applicant shall: | ||
a) change the establishment’s name if there is already a validly registered name similar to it. | |||
b) display the duly approved LTO in a conspicuous place within the establishment. | |||
c) notify BFAD/BAI in case of any change in the circumstances described in the application, among others; change of location, change of veterinarian, change of pharmacist, change in veterinary drugs and products. | |||
2.1.1.8 | An authenticated photocopy of Contract of Lease for the space to be occupied if the applicant does not own it. |
2.2.1.1 | Guidelines on Current Good Manufacturing Practices (GMP) provided for under A.O. No. 220 s. 1974, as amended including location, building and floor plans, and any additional guidelines issued by BFAD. | |
2.2.1.2 | Minimum standards for pharmaceutical manufacturing equipment/machines owned by the manufacturers described in Annex A* | |
2.2.1.3 | Minimum standards for quality control facilities owned by the manufacturers described in Annex B* | |
2.2.1.4 | If importing raw materials, active ingredients and/or finished products for use in manufacture of veterinary drug and products, a certificate that the manufacturer is registered in the country of origin, duly authenticated by the territorial Philippine Consulate, and evidence that the manufacturer meets BFAD/BAI standards for local manufacturers. If inspection of the foreign manufacturer by BFAD/BAI is necessary, the cost of inspection shall be borne by the applicant establishment. However, in lieu of the above, a Certification Scheme from WHO or from an acceptable equivalent drug regulatory agency or organization. |
2.2.2.1 | Guidelines on Current Good Manufacturing Practices (GMP) provided for under A.O. No. 220 s. 1974, as amended including location, building and floor plans, and any additional guidelines issued by BFAD, Administrative Order No. 9, issued by BAI and other guidelines as required by NDC and other agencies. | |
2.2.2.2 | Minimum standards for veterinary biological manufacturing equipment/machine described in Annex C*. | |
2.2.2.3 | Minimum standards for quality control facilities described in Annex D*. | |
2.2.2.4 | If importing raw materials, active ingredients and/or finished products for use in manufacture of veterinary drug and products, a certificate that the manufacturer is registered in the country of origin, duly authenticated by the territorial Philippine Consulate, and evidence that the manufacturer meets BFAD/BAI standards for local manufacturers. If inspection of the foreign manufacturer by BFAD/BAI is necessary, the cost of inspection shall be borne by the applicant establishment. |
2.2.3.1 | Relevant Guidelines on Current Good Manufacturing Practices (GMP) provided for under A.O. No. 220 s. 1974, as amended including location, building and floor plans, and any additional guidelines issued by BFAD and Administrative Order No. 35 issued by BAI. | |
2.2.3.2 | Minimum standards for Veterinary Medicated Feed Manufacturing equipment/machines described in Annex E.* | |
2.2.3.3 | Minimum standards for quality control facilities described in Annex F* whether owned or contracted by the manufacturer provided the contracted quality control facility is accredited by BAI. | |
2.2.3.4 | If importing raw materials, active ingredients, or finished products for use in manufacture of veterinary drugs and products, a certificate that the manufacturer is registered in the country of origin, duly authenticated by the territorial Philippine Consulate, in the absence of the Consulate any equivalent government regulatory agency and evidence that the manufacturer meets BFAD/BAI standards for local manufacturers. If inspection of the foreign manufacturer by BFAD/BAI is necessary, the cost of inspection shall be borne by the applicant establishment. |
2.2.4.1 | A valid contract of agreement with a BFAD/BAI licensed manufacturer containing a stipulation that both the veterinary drug trader and the manufacturer are jointly responsible for the quality of the veterinary drug and product; | |
2.2.4.2 | If importing raw materials, active ingredients, or finished products for use in the manufacture of veterinary drug and product, a certificate that the manufacturer is registered with the country of origin, duly authenticated by the territorial Philippine Consulate, any equivalent regulatory government agency and evidence that the manufacturer meets BFAD/BAI standards for local manufacturers. If inspection of the foreign manufacturer by the BFAD/BAI is necessary, the cost of inspection shall be borne by the applicant establishment. | |
2.2.4.3 | A description of the production process and quality control procedures to be followed by the contracted manufacturer, jointly certified by the owner and the pharmacist of the veterinary drug and product establishment. |
2.2.5.1 | Importers; | ||
2.2.5.1.1 Foreign Agency Agreement between the Philippine importer and foreign supplier duly authenticated by the territorial Philippine Consulate, in the absence of the Consulate, any equivalent regulatory government agency. | |||
2.2.5.1.2 A certificate that the manufacturer of the raw material, active ingredient, or finished product is registered in the country of origin, duly authenticated by the territorial Philippine Consulate, in the absence of the Consulate, any equivalent regulatory government agency and evidence that the manufacturer meets BFAD/BAI standards for local manufacturers. If inspection of the foreign manufacturers of the BFAD/BAI is needed the cost of inspection shall be borne by the applicant establishment. | |||
2.2.5.1.3 In case of finished products, Certificate of Free Sale of the product in the country of origin, duly authenticated by the territorial Philippine Consulate, in the absence of the Consulate, any equivalent regulatory government agency and evidence that such certificate is issued in substantial compliance with BFAD/BAI standards. | |||
2.2.5.2 | Exporters; | ||
2.2.5.2.1 A valid contract with BFAD/BAI licensed manufacturer in addition to other requirements set by other competent authorities. | |||
2.2.5.3 | Wholesalers | ||
2.2.5.3.1 A valid contract with a BFAD/BAI licensed veterinary drug and product manufacturer, trader or distributor. | |||
2.2.5.3.2 A certification that the products it sells are registered with BFAD/BAI. |
3.1.1 | Initial Period (Initial Application) 1 year | |
3.1.2 | Subsequent Period (Renewal Application) 2 years |
4.1.1 | Misrepresentation of any material fact in the application for LTO and in any documentation used as a basis for issuing the LTO. | |
4.1.2 | For manufacturers and traders: any deficiency in GMP that is likely to result in adulterated, misbranded, substandard, or unsafe products as determined by BFAD/BAI. This includes, among others, grossly inadequate premises, lack of key technical and professional personnel, lack of key equipment in production or quality control, poor or inadequate process control, and inadequate or improper documentation of the production process. | |
4.1.3 | For distributors: distribution of fake, substandard, misbranded, adulterated or unsafe veterinary drugs and products. | |
4.1.4 | Violation of BFAD/BAI standards of quality, efficacy, purity and safety of veterinary drugs and products. | |
4.1.5 | Sale and distribution of therapeutic antibiotic and biological products without batch certification by BFAD/BAI. | |
4.1.6 | Failure to keep up-to-date, secure, orderly, and easily inspected records that would indicate continued compliance with standards. |
4.2.1 | Minor deficiencies in GMP or material management that need to be corrected but are not immediately or likely to result in adulterated, misbranded, substandard or unsafe veterinary drugs and products as determined by BFAD/BAI. These include, among others, poor housekeeping, inadequate storage facilities, non-functional equipment, and failure to comply with laboratory safety standards. | |
4.2.2 | Lapses in record keeping of invoices, receipts or distribution records. |
Veterinary Drug and Product Manufacturer
(Code VDAPM)
Veterinary Drug and Product Trader
(Code VDAPT)
Veterinary Drug and Product Distributor
(Code (VDAPDW)/VDAPDE/VDAPDI)
Code Initial Renewal
(good for 2 years)VDAPM P5,000 P10,000VDAPT 3,000 6,000VDAPDW/VAPDE/VPAPDI 2,000 4,000
2.1.1 | Application of any person desiring to operate or establish a veterinary drug and product outlet shall file with the BFAD/BAI application supported by the following documents: | |||
2.1.1.1 | A standard petition form containing among others the name, age, citizenship and a passport size picture (5 x 5 cm) of the petitioner and other pertinent circumstances pertaining to the proposed veterinary drug and product outlet including the place where it is to be established. | |||
2.1.1.2 | Proof of registration as an establishment, i.e.: | |||
a) For single proprietorship; an authenticated photocopy of the Certificate of Business Name Registration issued by the Bureau of Domestic Trade (BDT) of the Department of Trade and Industry. | ||||
b) For partnership, corporation, and other juridical persons, authenticated photocopies of the Certificate of Registration issued by the Securities and Exchange Commission (SEC) and the Articles of Incorporation or Partnership. | ||||
2.1.1.3 | A valid Certificate of Registration of the establishment’s Filipino Pharmacist/Veterinarian issued by the Professional Regulation Commission (PRC). | |||
2.1.1.4 | A certificate of attendance to a BFAD/BAI accredited Seminar for Licensing of veterinary drug and product outlet. | |||
2.1.1.5 | An Affidavit of undertaking providing that the applicant shall: | |||
a) change the establishment’s name if there is already a validly registered name similar to it. | ||||
b) display the duly approved LTO in a conspicuous place within the establishment. | ||||
c) notify BFAD/BAI in case of any change in the circumstances described in the application such as: change of location, change of pharmacist, etc. | ||||
2.1.1.6 | Tentative list of veterinary drugs and products intended to be sold using generic names with brand names when applicable. | |||
2.1.1.7 | An authenticated photocopy of Contract of Lease for the space to be occupied if the applicant does not own it. | |||
2.1.2 | For drugstore, pharmacy or botica, see Specific Requirements 2.2.1. |
2.2.1 | Drugstore, Pharmacy or Botica requirements are provided for in A.O. No. 56 s. 1989 and therefore shall secure the license to operate from the BFAD. However, they shall secure a license to operate from the BAI if they shall sell veterinary drugs and products. Such LTO shall be automatically granted by the BAI upon presentation of LTO from BFAD, payment of corresponding fees and tentative list of veterinary drugs and products intended to be sold using generic names with brand names when applicable. | |
2.2.2 | Veterinary and agricultural supply store, livestock and poultry supply store, are outlets selling prescription veterinary drugs and products. |
2.2.2.1 Premises3. Renewal of License to Operate (LTO) — In case of renewal of LTO the Veterinary drug and product outlet must have a history of satisfactory performance, consistent with BFAD/BAI standards and requirements, without any cases of serious violation of existing laws, rules and regulations.
2.2.2.1.1 A signboard in front of the place of business bearing the registered name of the veterinary drugstore. For veterinary drug and product outlet selling exclusively non-prescription or over-the- counter (OTC) or self-service veterinary drug and product, the signboard should indicate so by putting the symbol non-Rx or equivalent.
2.2.2.1.2 A well ventilated area not less than 12 sq. m. in floor area with concrete, tile or wooden flooring.
2.2.2.1.3 A suitable and proper place (e.g. refrigerator) for the adequate storage of veterinary drugs and products as specified on the label.
2.2.2.1.4 A suitable cabinet for keeping poisons and dangerous drugs, when applicable.
2.2.2.1.5 An adequate water and electrical supply.
2.2.2.1.6 Other additional requirements of BAI and FPA.
2.2.2.2 Reference Books and Documents
2.2.2.2.1 Philippine National Veterinary Drug Formulary.
2.2.2.2.2 Philippine Veterinary Drug Codex.
2.2.2.2.3 R.A. 3720, otherwise known as the “Foods, Drugs and Devices and Cosmetics Act” as amended and relevant implementing rules and regulations.
2.2.2.2.4. R.A. 6675, “Generics Act of 1988” and relevant implementing rules and regulations.
2.2.2.2.5 R.A. 5921 “Pharmacy Law”, as amended and relevant implementing rules and regulations.
2.2.2.2.6 R.A. 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 implementing guidelines.
2.2.2.2.7 R.A. 1071, “An Act to regulate the sale of veterinary biologics and medicinal preparation and relevant implementing guidelines”.
2.2.2.2.8 R.A. 1556 “Livestock and Poultry Feeds Act” and relevant implementing guidelines.
2.2.2.3 Record Books Duly Registered with the BFAD/BAI.
2.2.2.3.1 Prescription book
2.2.2.3.2 Dangerous Drugs Book, when applicable.
2.2.2.3.3 Poisons Book, when applicable.
2.2.2.4 A duly BFAD/BAI registered pharmacist or veterinarian.
2.2.2.5 Other Additional Requirements.
2.2.2.5.1 Invoices indicating the lot number or batch number of the manufacturer’s stock pursuant to BFAD Memo. Circular No. 001 s. 1983.
2.2.2.5.2 File of prescriptions filled, consecutively numbered.
2.2.2.5.3 Dry Seal or Rubber Stamp containing the name and address of the veterinary drug and product outlet.
2.2.3 Requirements for a Retail Outlet for Non-Prescription, Over the Counter and Self-Service Veterinary Drugs and Products.
2.2.3.1 Premises
2.2.3.1.1 A signboard in front of the place of business bearing the registered name of retail outlet and the symbol non-Rx or equivalent.
2.2.3.1.2 An adequate, well ventilated area with concrete, tile, or wooden flooring.
2.2.3.1.3 A suitable and proper place for the adequate storage of non-prescription drugs. When there are products sold other than drugs, area exclusively for veterinary drugs and products shall be allocated within the premises.
2.2.3.2 Reference Books and Documents
2.2.3.2.1 Philippine National Veterinary Drug Formulary
2.2.3.2.2 Philippine Veterinary Drug Index
2.2.3.2.3 R.A. 5921, “Pharmacy Law” and its implementing rules and regulations;
2.2.3.2.4 R.A. 6675 the “Generics Act of 1988” and relevant implementing rules and regulations;
2.2.3.2.5 R.A. 3720 as amended or “Foods, Drugs and Devices and Cosmetics Act”;
2.2.3.2.6 R.A. 3101, An Act authorizing the Director of Animal Industry to promulgate regulations for the preparation, sale, traffic in and shipment, and importation of viruses, seram, toxins, or analogue products used for the treatment of domestic animals and relevant implementing guidelines.
2.2.3.2.7 R.A. 1071, An Act to regulate the sale of veterinary biologics and medicinal preparation and relevant implementing guidelines.
2.2.3.2.8 R.A. 1556, “Livestock and Poultry Feeds Act” and relevant implementing guidelines.
2.2.3.3 Other Additional Requirements
2.2.3.3.1 Invoice indicating the lot number or batch number of the manufacturer’s stock pursuant to BFAD Memo. Circular No. 001 s. 1983.
2.2.3.3.2 Dry Seal or Rubber Stamp containing the name and address of the veterinary drug and product outlet.
4.2.1 | Failure to produce invoices and receipts together with lot number, expiry dates for the veterinary drugs and products in stock. | |
4.2.2 | Failure to properly record and keep a file of all prescriptions filled in the last two years. | |
4.2.3 | Refusal to allow entry of BFAD/BAI inspectors. |
4.3.1 | Sale or Offer for sale of adulterated, misbranded, sub-standard, unregistered, expired, or unsafe veterinary drugs and products marked “Not for Sale”. | |
4.3.2 | Failure to properly record dangerous drugs as determined by DDB. | |
4.3.3 | Lack of pharmacist/veterinarian. | |
4.3.4 | Failure to take necessary remedial or corrective measures within the prescribed period as directed by BFAD/BAI. |
6. Schedule of Fees — Upon application for a license to operate, the following non-refundable fees shall be charged for each application:
Initial Period
of Validity Validity of
Subsequent Renewal 1 year 2 years
Only upon payment of application fees may the application be processed. A surcharge of fifty percent (50%) of the above fees shall be imposed on applications for renewal filed after the validity of the license has lapsed.
Initial Renewal
(good for two years) P200.00 P400.00
(SGD.) SENEN C. BACANI Secretary of Agriculture | (SGD.) ALFREDO R.A. BENGZON, M.D. Secretary of Health |