Country Report : Philippines Presented by: Dr. Alicia A. Layson Department of Agriculture Bureau of Animal Industry

The Philippine Department of Agriculture The Department of Agriculture is the principal agency of the Philippine government responsible for the promotion of agricultural development growth. In pursuit of this, it provides the policy framework, helps direct public investments, and in partnership with local government units (LGUs) provides the support services necessary to make agriculture and agri-based enterprises profitable and to help spread the benefits of development to the poor, particularly those in rural areas.

The Philippine Department of Agriculture

Bureau of Animal Industry a national government agency under the Department of Agriculture mandated to develop the livestock and poultry industries and ensure disease prevention, control and eradication.

BUREAU OF ANIMAL INDUSTRY OFFICE OF THE DIRECTOR ANIMAL HEALTH ANIMAL FEEDS LABORATORY SERVICES LIVESTOCK DEVELOPMENT MARKETING RESEARCH ADMINISTRATIVE DIVISION

STATISTICS ON ANIMAL INVENTORY (livestock and poultry and aquaculture)

Livestock and Poultry Inventory by Year and Type (Unit: in thousand heads) Hog13, , , Chicken158, ,663,08154, Cattle2, , , Carabao3, , , Goat4, , ,174.25

Aquaculture Production by Year (Unit: in metric ton) AQUACULTURE 2,407, ,477,392.02

LAWS AND REGULATIONS ON VETERINARY DUGS

Republic Act No “Livestock and Poultry Feeds Act” -Regulate and control the manufacture, importation, labeling, advertising, distribution and sale of livestock and poultry feeds - Approved in 1956

Republic Act Food and Drug Administration Act of An act strengthening and rationalizing the regulatory capacity of BFAD, renaming it the FDA -Approved on Aug. 18,2009

RA No 3720 “Food, Drugs and Devices and Cosmetic Act” -ensures the safety, purity, and efficacy of drugs and devices being offered to the public -ensure the rational use of drugs and devices; not limited to banning, recalling or withdrawing from the market drugs which are not registered, unsafe and inefficacious; -Approved in 1967

DA-DOH MEMORANDUM OF AGREEMENT- Sept. 25, 1991 BAI shall take charge of the licensing of the establishments which engage in the manufacture, distribution and sale of veterinary drugs BAI shall take charge of the evaluation and registration of a. veterinary biologicals b. drugs intended for pre-mixes, water soluble supplements and animal feeds

Republic Act 8203 ( Counterfeit Law ) An Act prohibiting counterfeit drugs, providing penalties for violations Republic Act 6675 ( Generics Act of 1988) Promotes, requires, and ensures the production of an adequate supply, distribution, use, and acceptance of drugs and devices identified by their generic names.

Administrative Order (AO) No. 38, series of 1990 Regulations for the licensing of veterinary drug and product establishments and outlets

Dept. of Agriculture (DA) AO 11- Dept. of Health (DOH) AO 105, series of 1991 Requirements for labeling materials and veterinary drugs and products DA AO 33 – DOH AO 11, series of 1991 Rules and regulations on registration of veterinary drugs and products

DA AO No. 25, series of 1991 Registration and licensing of veterinary drugs and product premixes and water solubles, and corresponding manufacturers,importers, suppliers, distributors and retailers of said products with the Animal Feeds Standard Division, Bureau of Animal

DA No. 39 – DOH No. 111-B, series of 1991 Rules and regulations to implement prescribing requirements for the veterinary drugs and products

DA / DOH AO 111-D, series of 1991 Guidelines on DA No. 41 advertisement and promotions of veterinary drugs and products

RULES AND REGULATION Any person desiring to engage in the manufacture, importation, sale or distribution of veterinary drugs and products feed premixes and animal feeds should first be registered with the Bureau of Animal Industry No Veterinary Drugs and Products are exempted from registration especially those being offered for sale

Requirements for Registration 1. Brand Name Clearance (for branded products) 2. * Certificate of Free Sale from the country of origin 3. *Certificate of Good Manufacturing Practice from the country of origin. *Authentication issued by the Philippine Consulate from the country of origin

4. Stability studies – to justify claimed expiration date 5. Distribution Agreement between the importer and foreign manufacturer/supplier 6. Technical description of the Product 7. Manufacturing Process/Process Flow 8. Certificate of Analysis 9. Draft of the proposed label 10. Local Analysis

Generic Labeling Requirements Generic Name Brand name Dosage form and Strength Pharmacologic Category For Veterinary Use Only Formulation Indications Dosage and Administration Contraindications Precaution

Withdrawal period Storage Condition Prescription VDAP – Rx Caution: Complete Address of manufacturer, importer, and distributor BAI Registration Number Lot /Batch No Manufacturing Date Expiry Date Net Weight

Number of Registered Veterinary Establishments 2010 (as 0f Oct. 1, 2010) VDAPM VDAPT VDAPDI VDAPDW VDAPEx14118 VDAPO TOTAL

Number of Registered Veterinary Drug and Products 2010 ( as of Oct. 1, 2010) VRM (locally manufactured) VRT (toll manufactured) VRI (imported) TOTAL:

No. VDAPDI importing from Korea – 14 establishments No. of approved Korean suppliers – 13 establishments No. of approved veterinary products from Korea – 48 products Expired CPR- 41 Certificate of Product Registration

Products from Korea registered at BAI Antibacterial - 14 Vitamins - 6 Performance Enhancers - 7 Enzymes - 5 Minerals - 6 Acidifiers - 1 Probiotics - 2 Yeast - 3 Disinfectant - 1 Anticoccidial - 1 Insect Growth Regulator - 1 Anthelmintic - 1 TOTAL 48

Banned Veterinary Drugs for Use in Food-Producing Animals: 1. Chloramphenicol 2. Carbadox 3. Olaquindox 4. Nitrofurans 5. Beta-Agonist Drugs

NATIONAL VETERINARY DRUG RESIDUES CONTROL PROGRAM Governing laws: 1.RA 1556 “Livestock an Poultry Feeds Act”– competent authority is BAI 2.RA 3720 “Food, Drugs and Devices and Cosmetics Act”– competent authority is FDA 3. RA 7394 ‘Consumer Act of the Philippines”- DA for agriculture and fishery products, DOH for drugs

NATIONAL VETERINARY DRUG RESIDUES CONTROL PROGRAM Governing laws: 4. RA No 8550 “Philippine Fisheries Code of 1998” – competent authority is BFAR 5. RA No 9296 “Meat Inspection Code” – competent authority is NMIS

DA AO 14 Series of 2006 Subject: Implementation of the National Veterinary Drug Residues Control Program and Creation of the Inter- agency Committee Objective: 1) ensure compliance to international standards on residues of veterinary drugs in food and 2) rational drug use in feeds

Creation of the Inter-agency Committee: Undersecretary for Livestock and Fisheries as Chair, Bureau of Agriculture Fisheries and Product Standards as Vice-chair, Members from Bureau of Fisheries and Aquatic Resources, Bureau of Animal Industry, National Meat Inspection Service, National Dairy Authority, Philippine Carabao Center, Livestock Development Council, Legal Service, Industry Associations, Professional groups

Contextual Developments Philippines continue to export fishery and aquatic products to EU poultry exports to Japan resumed after HPAI clearance initiative to export of pork to Singapore; FIS AO issued; traceability

Contextual Developments Good Practices as production standards drafted and issued (GAP, GAqP, GAHP, GMP/HACCP) Codex adopted “Design and Implementation of National Regulatory Food Safety Assurance Program Associated with the Use of Veterinary Drugs in Food Producing Animals”

MARAMING SALAMAT… THANK YOU…