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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

ADMINISTRATIVE
DIVISION

LABORATORY LIVESTOCK
ANIMAL HEALTH ANIMAL FEEDS DEVELOPMENT MARKETING RESEARCH
SERVICES
STATISTICS ON ANIMAL
INVENTORY
(livestock and poultry and
aquaculture)
Livestock and Poultry Inventory by Year and Type
(Unit: in thousand heads)

2010 2009 2008

Hog 13,397.79 13,596.40 13,701.02


Chicken 158,927.34 158,663,08 154,272.04
Cattle 2,596.03 2,586.39 2,566.49
Carabao 3,320.30 3,320.97 3,338.57
Goat 4,203.71 4,222.23 4,174.25
Aquaculture Production by Year
(Unit: in metric ton)

2008 2009
AQUACULTURE 2,407,697.92 2,477,392.02
LAWS AND REGULATIONS ON
VETERINARY DUGS
Republic Act No. 1556 “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 9711
- Food and Drug Administration Act of
2009
- 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 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.

Republic Act 8203 (Counterfeit Law)

An Act prohibiting counterfeit drugs,


providing penalties for violations
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 2009 2008
(as 0f Oct. 1, 2010)

VDAPM 55 47 34
VDAPT 32 24 22
VDAPDI 276 171 138
VDAPDW 36 37 41
VDAPEx 14 11 8
VDAPO 270 224 164

TOTAL 683 514 407


Number of Registered Veterinary
Drug and Products
2010 2009 2008
(as of Oct. 1, 2010)

VRM 496 780 676


(locally manufactured)

VRT 193 392 390


(toll manufactured)

VRI 1237 2036 1903


(imported)

TOTAL: 1826 3208 2969


• 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…

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