Revised Veterinary Biological Product Regulations

March 15, 1982

BAI ADMINISTRATIVE ORDER NO. 09-82

For a more effective implementation of Act No. 3101, Act No. 3639 and Republic Act No. 1071, Animal Industry Administrative Order No. 10 Series of 1952 is hereby revised. The following revised rules and regulations governing the production, manufacture, handling, sale, distribution, shipment, importation and exportation of veterinary biological product intended for the diagnosis, treatment and prophylaxis of animal diseases in the Philippines are hereby promulgated for the information and guidance of all concerned:

ARTICLE I

Title, Objectives and Scope

SECTION 1. Title. — This Order shall be known as the Revised Veterinary Biological Product Regulations.

SECTION 2. Objectives. — This Order shall have the following objectives:

a. Maintain a high standard of production, manufacture and handling of Veterinary biological products in the Philippines;

b. Prevent the sale, distribution and trading in the Philippines of worthless, impotent and unsafe veterinary biological products;

c. Provide criteria for the issuance of permit for importation into the Philippines of foreign-produced or manufactured veterinary biological products;

d. Ensure that veterinary products exported from the Philippines are of high quality products.

ARTICLE II

Definitions

SECTION 3. Definition of Terms. — For purposes of these regulations the following words, terms and phrases as herein used shall mean:

a. Veterinary Biological Products — These words sometimes referred to as veterinary biologicals or biological products, shall mean all viruses, bacteria, live micro-organisms, killed micro-organisms, components or products of micro-organisms, antisera and other homologous substances whether of natural or synthetic origin, intended for use in the diagnosis, treatment and prophylaxis of diseases of animals or for the identification of the causative organisms of a disease of animals. CIAHDT

b. Micro-organisms — Sometimes referred to as organism, shall mean any virus, bacteria, protozoa and other minute parasites which cannot be seen by the naked eye and has the capability of causing or disseminating disease in animals.

c. Preparation of micro-organisms for Veterinary Use — Sometimes referred to as "preparation" or "Production" means the processes thru which an organism is rendered innocuous and made usable for the treatment, diagnosis and prophylaxis of animal diseases.

d. Animals — Refers to horses, mules, asses, cattle, carabaos, buffaloes, sheep, goats, swine, cats, dogs, poultry, wild animals, such as deer, wild hogs, zoo animals, show and circus animals, household pets and laboratory animals used for diagnostic and experimental purposes.

e. Person — Any individual, firm, partnership, corporation, company, society, association or other organized group of any of the foregoing or their agent, representative, officer and employee or animal owner, handler, caretaker, and words of similar import.

f. Minister — refers to the Minister of Agriculture.

g. Ministry — refers to the Ministry of Agriculture.

h. Director — refers to the Director of the Bureau of Animal Industry.

i. Laboratory Services Division (LSD) — refers to the Laboratory Services Division of the Bureau of Animal Industry.

j. Establishment — refers to the buildings and premises or place where veterinary biological products are being produced, manufactured, stored or processed or any place where the object of business is a veterinary biological product.

k. Inspector — refers to any officer or employee of the Bureau of Animal Industry appointed pursuant to Civil Service Rules as Biological inspector or one designated by the Director to perform biological inspection work.

l. Veterinary Biological Product Import Permit — means a document, sometimes referred to as Import Permit, issued to a qualified person allowing him to bring into the Philippines specific veterinary biological products subject to restrictions and control as provided in this Order.

m. Licensee — refers to a person to whom a valid license to prepare, produce or manufacture veterinary product has been issued.

n. Permittee — refers to a person to whom a permit to import veterinary biological product(s) has been granted.

o. Distributor — a person who sells or distribute, either to a retailer, and user or other distributor or otherwise place in the channels of trade one or more biological products he does not produce nor import.

p. Handling — refers to mixing, combining, reconstituting, repacking, storing, packaging, transporting of veterinary biological product.

q. Outline of Production — a detailed protocol on the steps, procedures, techniques followed in the preparation, production or manufacture of biological product.

r. Quality Control — refers to the test and services performed in the Quality Control Section of the laboratory Services Division to determine and ascertain the purity, safety, sterility and potency of the biologics, their efficacy and other desirable characteristics. HCATEa

s. Standard Requirements — refers to the tests, methods, procedures and criteria established or prescribed by the Laboratory Services Division in evaluating the various qualities and characteristics of a biological product to insure its purity, safety, potency and efficacy and to determine that such product is not worthless, contaminated, adulterated, dangerous or harmful to animals as construed in the provisions of this Order.

t. Pure or Purity — refers to the quality of a biological product prepared in its final form of being free of extraneous micro-organism or other materials (organic or inorganic) as determined by Quality Control.

u. Safe or Safety — refers to the quality of a biologic of being free from properties that cause undue local or systematic reactions when used as recommended or suggested by the manufacturer.

v. Sterile or Sterility — refers to freedom from viable contaminating micro-organism as demonstrated by standard procedures and criteria of the LSD.

w. Potent or Potency — refers to the relative strength of a biological product as measured by test in the LSD.

x. Efficacious or Efficacy — refers to the specific ability or capability of the biological product to effect or produce the result for which it is offered when used under the conditions recommended by the manufacturer.

y. Serial Number — refers to the number or numbers and letters used to identify and distinguish one series of biologicals from other series of the same type or kind of biological.

z. Expiration Date — refers to the date designating the end of the period during which a biological product, when properly stored and handled, can be expected with reasonable certainty, to be efficacious.

aa. Label — refers to all written, graphic or printed matter:

i. upon or attached to a final container of a biological product;

ii. appearing on any immediate carton or box used to package such final container; and

iii. appearing on any accompanying enclosures (leaflets, inserts, or circulars) on which required information or directions as to the use of the biological product shall be found.

ARTICLE III

Registration, Accreditation and Licensing

SECTION 4. Registration Required. — Any person desiring to engage in the production, manufacture, handling, marketing, distribution, importation or exportation of any veterinary biological product in the Philippines shall first be registered in the office of the Director.

Other agencies, branches and subdivisions of the Philippine government authorized by law to grant licenses shall not frant any person a license to operate or engage within their respective jurisdiction in which a veterinary biological product is the object of trade or commerce, unless such person or his agent can present or show to the licensing agency a valid BAI Certificate of Registration as Veterinary Biological Product producer, manufacturer, handler, retailer, wholesaler, distributor, indentor, importer or exporter as the case may be.

SECTION 5. Accreditation and License. — Any person to whom a valid Certificate of Registration has been issued by the Director or his authorized representative is deemed also accredited and shall be permitted to engage in such business or deal in such product so specified in his Certificate of Registration, subject to the restrictions and limitations provided in this Order, and other pertinent laws, rules and regulations. ASICDH

A valid Certificate of Registration shall partake of the nature of a license as contemplated in the provisions of Section 4 of Act 3101 when issued to a person who shall prepare, produce or manufacture veterinary biological products in the Philippines.

SECTION 6. Persons Qualified to Register. — No person shall be registered and permitted to produce, manufacture, handle, distribute, market, import or export veterinary biological product in the Philippines unless he meets the following qualifications and conditions:

a. He must be a Filipino citizen or a permanent resident in the Philippines operating a permanent business in the Philippines;

b. He has no court record of previous conviction for illegal production, manufacture, handling, distribution, or marketing of veterinary biological in the Philippines;

c. His establishment or place of business is in accordance with the standard and criteria prescribed by the Bureau, and if such establishment if for the manufacture and handling of veterinary biologics, it shall be operated under the direction and supervision of a competent person sufficiently trained in the prescribed techniques of preparation or manufacture of such veterinary products specified in the application for registration; and

d. If he operates a branch, subsidiary or franchised establishment of a foreign-based company, such person shall have a valid contract or memorandum of agreement with the foreign mother company. 

SECTION 7. Application for Registration. — All applications for registration shall be done in writing and shall be addressed to the Director stating therein the following:

a. Name and complete address of the applicant, establishment or company.

b. Nature of the intended business.

c. Kind and type of the veterinary biological product to be the object of the business.

d. Amount of capitalization, indicating the paid-up capital.

e. Names of the principal officers and incorporators and their respective addresses.

f. Name and address of the foreign based-mother company if the applicant is a branch, subsidiary or franchised producer of a foreign company.

If the application is for the start of a business or there is a change of ownership, location or nature of business, the letter of application for registration shall be accompanied by the following documents:

a. Articles of incorporation and by-laws in case of a corporation.

b. Certificate of registration with the Securities and Exchange Commission if the applicant is an existing business.

c. List of technical officials and employees who shall undertake the actual preparation or production of the veterinary biological products and their credentials in case the establishment is a manufacturing concern.

d. Plans of the building and layout of machineries and equipment in case of the start or expansion of business.

e. List of facilities and equipment for the manufacture, production, handling, distribution and shipment of biologics.

SECTION 8. Inspection Required. — An inspection of the establishment and its equipment by an authorized Bureau agent shall be made before approval of any application for registration and only those conforming with the standards and criteria set by the Bureau shall be recommended for final approval. LLpr

SECTION 9. Validity of the Certificate of Registration. — Regardless of the date of issue, each Certificate of Registration shall be valid up to the last day of the calendar year for which said certificate has been issued unless otherwise earlier revoked or suspended in accordance with the provisions of this Order. Voluntary termination of operation of business before the expiration of a duly approved Certificate of Registration shall be reported to the Director.

A change of the nature of business or the location of a business establishment automatically voids the existing License or Certificate of Registration.

SECTION 10. Renewals. — Subsequent renewals of Certificate of Registration shall be applied for not later than the end of the third (3rd) month of the succeeding year. Before approval of the request for renewal an inspection of the establishment and its equipment shall be made and only those conforming with the standards and criteria shall be approved.

SECTION 11. Suspension and Revocation of Certificate of Registration. — Violation by the grantee of Certificate of Registration of any of the prescribed standard and criteria, the terms and conditions of the Certificate, and any pertinent provision of this Order shall constitute a ground for the suspension or revocation of the Certificate anytime before its expiration. A licensee shall be given opportunity to be heard before the suspension or revocation of his license and the Director may create a committee of responsible officials of the Bureau for this purpose. The suspension Order may be lifted after correction of the deficiency causing the suspension.

In case of failure to correct the deficiency within the period prescribed by the Director, the registration or license shall be deemed automatically revoked.

SECTION 12. Registration of Veterinary Biological Product. — Before any class, type, kind, brand or trade-mark of veterinary biological product is allowed to be produced, manufactured, imported to or exported from the Philippines the same shall be registered in accordance with the Order.

Each type, brand or trade mark of veterinary biological product shall be registered individually and should be assigned separate registration numbers. The LSD shall keep a permanent Book of Records of the registration number and code assigned and each product and indicate therein the class, type, brand or trade mark, technical description and manufacturer/distributor of each biologic registered.

A change or substantial modification of the method of production of a particular product shall be a cause for requiring a separate registration for the product manufactured.

SECTION 13. Prerequisites for Registration of Veterinary Biologicals. — The following conditions shall be satisfied before any veterinary biologic shall be approved for registration and allowed to be utilized for the treatment, diagnosis or prophylaxis of animal diseases in the Philippines or to be exported to foreign countries:

a. The animal disease for which the biologic is intended has been officially confirmed to be present in the Philippines by the Bureau.

b. The procedures of production and manufacture conform with the standards and criteria set by the Bureau or in accordance with the procedures approved by internationally reputable organizations, associations or societies of experts.

c. The biologic has passed the standard tests and found to be safe, pure, potent and not otherwise contaminated, adulterated, dangerous, harmful to animal, worthless, inefficacious or the value thereof is inferior to that announced on the label.

d. In addition to conditions a, b, and c above, veterinary biological products manufactured or produced in a foreign country should be certified by the Head of the appropriate Ministry or government office of the country where such veterinary biologics were manufactured or produced to have passed the standards and criteria on biologic manufacture of that country and have been duly registered therein. Such certification should be authenticated by an authorized Philippine Embassy/Consulate official assigned nearest the Head Office of the Company which manufactured the said veterinary biological products. ICHcaD

SECTION 14. Causes for Cancellation of Registration Certificate. — The registration of any veterinary biologics shall be cancelled under any of the following conditions:

a. When the biologics is withdrawn from the open market by the manufacturer, producer or importer or the said biologic is no longer available in the normal channels of trade and commerce in the Philippines for a period of two years.

b. When the veterinary biologic has been verified by authorized investigator of the Bureau to have caused damages to Livestock in the Philippines or when the meat of animals treated therewith became unfit for human consumption because the residues found in such meat are injurious to human beings.

c. When the veterinary biologic has been found to have deteriorated in quality as proven by findings of the Quality Control Section of the LSD.

d. When such product has been banned for animal use at the country of origin in case such product is foreign-made.

SECTION 15. Application for Registration of Veterinary Biological Products. — The application for the registration of veterinary biological products shall be in letter form addressed to the Director. The following information be stated in the application:

a. Name and address of the applicant.

b. Name, brand or trade mark of the product.

c. Certificate of worthiness, safety, purity and potency from the government agency concerned in the country of origin if the product will be imported into the Philippines.

d. Certificate of the exporting country that the product is not banned for animal use in that country.

e. Copy of the report on the tests to which the product or the initial samples have been subjected by the Quality Control Section of the BAI.

f. Samples of the labels.

ARTICLE IV

Manufacture, Production and Handling

SECTION 16. Location of Establishment. — The establishment for the manufacture and production of veterinary biological products should be situated at a suitable place where the outbreak of animal diseases can be easily avoided or controlled, and the whole area should be properly fenced and fully secured so as to exclude any possibility of spreading to the outside any organism which is the object of manufacture, production or test.

SECTION 17. Stables, Barns and Houses for Laboratory and Other Animals. — The animals needed in the production or testing of the biological products should be confined in appropriate buildings which are properly ventilated, lighted, drained, guttered, screened and kept always in sanitary conditions. Such buildings should be so constructed as to exclude the possibility of the confined animal going astray outside the building and prevent the entry of wild and astray animals, and the solid and liquid wastes therefrom should be sterilized or properly disinfected and treated before final disposition.

SECTION 18. Animals Used in Production and Disposal. — Animals used in the production of biologics should be affected with no disease other than for which the said biologics are intended to be used. Animals exposed to or infected with the organism which are the object of production, should not be slaughtered for human consumption. Such animals or their parts should not be brought outside the establishment. The remains of such animals should be destroyed and properly buried or cremated.

Animals infected with one organism or used in the production or test of one product should not be mixed or come in contact with the animals to be used for the production or test of another product or organism. ADHCSE

SECTION 19. Equipment and Apparatuses. — There should be a separate set of equipment and apparatuses for each line of product. However, an equipment or apparatus being used in the production may be used in the production of another product provided such equipment or apparatus shall be properly sterilized before and after being used in the production of the second product; provided; further, that such transfer or use has been reported to and approved by the Director. 

All equipment, containers, machinery, instrument and other apparatuses used in the production of viruses, sera, and toxin, before and after using, should be thoroughly sterilized at a temperature of not less than 120 degrees centigrade for at least 30 minutes or exposed to dry heat of not less than 160 degrees centigrade for at least 60 minutes. If for any reason such sterilization cannot be applied, then a process known to be equally efficacious for destroying micro-organism and their spores may be substituted upon expressed approval of the Director or his authorized agent.

SECTION 20. Sanitation and Hygiene of Personnel. — Every person involved in the production of veterinary biologics shall undergo regularly thorough physical and medical examinations and only those found without any contagious disease shall be permitted to perform activities directly connected with production processes.

Only authorized personnel should be allowed to enter the production rooms and such persons should properly disinfect themselves before entering and after leaving the rooms or buildings of actual production.

The personnel working inside the production room should wear a separate outer clothing and footwear while inside and such clothing and footwear worn inside the production room should not be brought outside unless same have been properly sterilized.

SECTION 21. Product Containers, Packing and Packaging. — Each product should be packed in suitable containers which conforms with the quality standard set by the Bureau.

The packing and packaging should be done under strict sanitation and hygiene and supervised by a competent person.

SECTION 22. Repacking. — No repacking of foreign-made product shall be done in the Philippines without the knowledge and expressed consent of the Director. Likewise Philippine-made product shall not be repacked by any person except the original manufacturer or producer or his authorized agents. Such repacking shall have the prior approval of the Director. When a foreign-made product is being repacked in the Philippines by authorized persons, the original brand or trademarks should appear on the label of the repacked product and the name and address of the original manufacturer and the name and address of the company repacking the product should likewise appear conspicuously in the labels.

SECTION 23. Labelling. — The label of veterinary biological products a manufactured, produced, imported and marketed in the Philippines should be affixed firmly on a conspicuous side of each container and package. The words should be legibly and plainly printed in English or Pilipino. The following information should appear on the label:

a. The name, brand or trademark of the product.

b. The registration number in the Philippines.

c. The type, kind, nature or brief description of the product.

d. The net quantity of the container, strength per unit quantity, dosage, route of administration, uses and purposes.

e. Name and address of original manufacturer/producer.

f. Name and address of person responsible for placing the product in the Philippine market.

g. Name and address of the packing company in case of repacked product.

h. Serial No., Code No., Batch No., date of manufacture and expiry date. HAISEa

SECTION 24. Storage. — All veterinary products produced, manufactured, handled or imported in the Philippines shall always be kept in cold storage at a suitable temperature so as to maintain the desirable qualities of such products. The area, equipment and facilities for storage shall, before being utilized for storage, be inspected by authorized Bureau agents to determine their suitability for storage; and when the same are being utilized, the Bureau inspectors shall regularly inspect such areas, equipment and facilities to determine if they are maintained under conditions suitable for storage.

All persons who have in their custody or possession any veterinary biological product which are intended for sale anywhere in the Philippines shall exercise the care in maintaining the desirable qualities of the said products and shall see to it that storage temperature is maintained at all times within the recommended range or level.

SECTION 25. Restriction on the Sale of Veterinary Biological Product. — The sale of any veterinary biological product to the public for the treatment, diagnosis or prophylaxis of animal diseases shall be authorized only at registered establishments, Veterinary clinics or hospitals, government veterinary offices or in outlets supervised by licensed veterinarians. Only veterinary biologics which have been duly registered in the Bureau shall be allowed to be sold at the authorized establishments.

SECTION 26. Product Which are Prohibited for Sale. — The following veterinary products are prohibited to be sold to the public:

a. Products not registered with the Bureau.

b. Products that have lapsed expiration date.

c. Products with detached, torn, obliterated, blotted or unreadable label.

d. Products with broken, cracked or leaking containers.

e. Products with broken cover or seal.

f. Products found to be adulterated, contaminated or whose value is inferior to that announce in the label.

ARTICLE V

Import and Export

SECTION 27. Import Permit Required. — It is prohibited for any person to bring into the Philippines any veterinary biological product without a valid Veterinary Biological Product Import Permit (VBPIP) issued by the Director. A separate Import Permit is required for each Brand or Trademark of Product and for every shipment thereof arriving in any port or entry in the Philippines. A shipment may consist of a number of package, crates or cartons containing either uniform of various unit sizes of the product final containers, with one or more serials or subserials or lot as indicated by a code number, arriving all at one time in one port of entry or in several portions or batches, all arriving in one port within a period of ninety (90) days from the date of the arrival of the first batch.

In case the arrivals of such products are in several batches, the quantities and descriptions of those which have already arrived should be properly noted or listed at the back of the original and duplicate copies of the corresponding biological Import Permit by the Veterinary Quarantine Officer/Inspector on duty and attested by the Bureau of Customs Examiner/Inspector assigned at the port of entry during the time of arrival of the said batches or products.

SECTION 28. Validity and Duration of a Biological Import Permit. — A Veterinary Biological Product Import Permit shall be valid only for one hundred eighty (180) days from the date of issue or up to the last day of the calendar year said Import Permit was issued, whichever date comes earlier. When a particular batch or shipment of a product has been loaded at the port on the country of origin on or before the expiration of the corresponding import permit, such shipment or batch shall be considered having still a valid import permit when it arrives in the Philippines even if the date of arrival is beyond the expiry date of its corresponding import permit provided that the date of loading has been properly certified by a veterinary inspector at the port of loading. aDICET

Each Veterinary Biological Product Import Permit shall be for the entry of one brand or trademark of product involving one particular shipment, and is not transferable to other person.

SECTION 29. Classification of Import Permit. — There shall be three classification of Veterinary Biological Product Import Permit to be issued by the Director which shall be called as follows:

a. Provisional Import Permit — This shall be issued only for the entry into the Philippines of a very limited quantity of particular veterinary biologics to be used for the various tests and evaluations by the Quality Control Laboratory of the Bureau as pre-requisite for the registration of said product. All the products imported under this class of permit shall be deposited at the Quality Control Laboratory of the Bureau.

b. Regular Import Permit — This shall be issued from time to time to registered importers for the entry in the Philippines of veterinary biologics which have been duly registered pursuant to Sections 12 and 13 of this Order.

c. Special Import Permit — This shall be issued only for the entry of unregistered products which shall be used for special purposes which the Director deems necessary for the control and/or diagnosis of particular animal diseases in the Philippines. The Director shall specify the terms and conditions of the entry of said product, defines, and indicate the species of animals to be treated or diagnosed and the names and addresses of the principal end-users. Any violation by the importer or end-user of the terms and conditions of the Special Import Permit shall constitute as unlawful act punishable pursuant to the provisions of this Order.

SECTION 30. Application for Veterinary Biological Product Import Permit. — The request or application for Veterinary Biological Product Import Permit shall be in writing and should be addressed to the Director. The application shall contain the following information:

a. The name and address of importer;

b. Class of Import Permit requested;

c. Name (brand/trademark) class, type and nature of the product to be imported;

d. Name and address of the product manufacturer/producer;

e. Country of origin;

f. Quantity (dose or volume) to be imported;

g. Purpose for which the product will be used;

h. Approximate date of shipment;

i. Means of transport; and

j. Port of entry.

In addition to the above information, the following should be included with the request depending on what class of permit is being requested:

a. For Provisional Import Permit:

(i) Brief description of the product;

(ii) Three copies of the product protocol or outline;

(iii) Proposed plan of evaluation;

(iv) List of the numbers and species of animals and/or culture cells involved in the production or tests; 

(v) List of test reported or abstract of researches and data to support the claim of producer or manufacturer; and

(vi) Sample of the label and/or empty final container; and

(vii) Certificate of Free Sale. IADCES

b. For regular Import Permit

(i) Registration Certificate of the Importer and the product;

(ii) Copies of container label;

(iii) Report of the balance of previous import if any; and

(iv) Inspection certificate of worthiness of storage facilities and equipment (issued by licensed Refrigeration Engineer or the equivalent).

c. For Special Import Permit

(i) Sworn statement of the importer or end-user testifying to the urgent need of the veterinary biologic and shall also state the number and species of animals to be administered with the biologics, location or site of the farm/project where the biologic will be used;

(ii) Three copies of the protocol and outline of production or test;

(iii) List of test and research data proving the efficacy or effectiveness of the product; and

(iv) If the biologic is for a pure research project, the importer shall submit the approved research outline and methodology of the research.

SECTION 31. Permit to Import may be Denied on Certain Conditions. — The Director or his representative shall not grant any person the permit to bring into the Philippines any veterinary biological product produced in a foreign country under any of the following circumstances:

a. When the product or a fraction of the product is for the control or treatment of an animal disease which is not officially confirmed to be present in the Philippines.

b. When the product has been banned for animal use in the country of origin or has been proven to have unfavorable residual or side-effect to persons consuming the meat or meat product of animals injected with such product.

c. When there is no Certificate of Registration or of Free Sale issued by the government officer concerned at the country of origin.

d. When the data submitted by the importer is inadequate to support the claims on the merit of the product.

e. When the applicant-importer has been found guilty of misdemeanor punishable by this Order.

SECTION 32. Suspension or Revocation of Import Permit. — A veterinary biological product import permit already issued to a person may be suspended or revoked by the Director in order to prevent its being used or further used if a portion of the shipment has already arrived, before the expiry date under the following circumstances:

a. When the Director has strong reason to believe that the said permit shall be used or has been used to import worthless, contaminated, adulterated, dangerous or harmful biological products.

b. When there has been found prima facie evidence of fraud or willful intent to deceive in the application papers for the said import permit.

c. When the importer-grantee has been found guilty of misdemeanor punishable by this Order.

The importer whose import permit has been suspended or revoked shall be given chance to present his side. However, failure on his part to rectify the deficiency mentioned in the suspension order after 30 days from notice thereof shall mean automatic revocation of the permit. EcSaHA

A person who has received a notice of suspension shall refrain from bringing into the Philippines the biologics intended to be imported until given clearance by the Director. Further importation or insistence in bringing in biologics after the suspension or revocation of an import permit shall constitute an unlawful act punishable by this Order.

SECTION 33. Prohibiting the Release of Foreign-Made Veterinary Biologics at the Ports of Entry under Certain Conditions.— Veterinary biological products brought into the Philippines from a foreign source, when already landed at the port of entry, shall not be released from the Customs Zone under the following conditions:

a. There is no prior valid permit issued by the Director or his authorized representative allowing the entry of such product or the permit has been suspended or revoked.

b. The expiration date of the product has already elapsed or will elapse within 180 days from the date of arrival.

c. The product contains a fraction or component not expressly authorized in the import permit.

d. The product originated from a foreign source other than what has been authorized and/or the shipment has passed thru ports which are expressly prohibited under the terms or conditions of the Import Permit.

e. There is strong reason to believe that the product has been opposed to unsuitable temperature while in transit, such as busted outer containers, lack of refrigerant, unsuitable outer containers, and other similar reasons.

f. The labels on the final containers have been changed, altered, erased, blotted or illegibly printed so as to mislead, deceive or purpost to show that the imported product conforms with the requirements of the Import Permit.

SECTION 34. Unlawful Importation of Veterinary Biologics and Disposition Thereof. — Any veterinary biological product brought into the Philippines from any foreign source without a valid import permit, imported in violation of the applicable provisions of this Order or under conditions expressed prohibited by this Order, shall be deemed unlawfully imported veterinary biological products and the person or persons responsible for such unlawful importation shall be punishable by the penalties provided for on this Order. The international transport company which owns the vessel or craft transporting to the Philippines the cargo of biologics which has no valid import permits shall be deemed necessary to the unlawful act.

All veterinary biological products imported or brought into the Philippines unlawfully shall be disposed of in any of the following manner:

a. Confiscated and turned over to the Bureau of Animal Industry for final disposition.

b. Returned to the country of origin at the expense of the owner, importer or carrier.

c. Destroyed and burned at the expense of the owner.

The above penalty shall be in addition to the penalty imposed on the person responsible for the unlawful importation.

SECTION 35. Permit or Clearance to Export Veterinary Biologics. — No person shall export to any foreign country any veterinary biologics which are produced or imported in the Philippines without clearance from the Director. Only veterinary biologics registered in the Bureau may be given clearance to be exported to foreign countries, except those brought to the Philippines and are being returned to the country of origin pursuant to the provisions of Section 35 of this Order and those unloaded at the ports and/or airports in the Philippines which shall be immediately transferred to other vessels or aircrafts for transhipment to another country; provided that such transhipment has the prior knowledge and approval of the Director or his authorized representative. ECaITc

SECTION 36. Inspection of Biologics for Export or Transhipment. — Any veterinary biologics exported or transhipped is subject to inspection by agent of the Bureau pursuant to Section 35.

ARTICLE VI

Inspection

SECTION 37. Compulsory Inspection of Establishment. — All establishments in the Philippines where a veterinary biological product is being produced, manufactured, handled, stored or sold are subject to compulsory inspection by authorized inspectors or agent of the Bureau. The inspection may be conducted at any convenient time of the day or night, with or without previous announcement or advise to the owner thereof; such inspection may include all or parts of the building, premises, facilities, equipment, apparatuses, product container, receptacles, labels and the methods, materials and processes of production, manufacture, storage or handling.

It shall be the duty of the owner to allow the inspection of all the premises and facilities of the establishment provided the Bureau inspector presents a valid mission order signed by the Director or his authorized assistants.

SECTION 38. Occasions for Inspection. — Inspection of establishments, facilities and equipment shall be conducted when any of the following circumstances are present:

a. There is an application for a license to engage in the production or manufacture of any veterinary biological product.

b. There is an application for a permit (Registration Certificate) to operate a business in the production or manufacture of veterinary biological products.

c. There is a request for the renewal of a license or registration or a request for the lifting of the prior suspension of an unexpired license or registration.

d. There is an application for permit to import, for the first time, a foreign-made product.

e. There is a request for a license to produce a new line or additional kind of veterinary biologics.

f. There is a substantial change or modification in the process or method of production of the biologic being produced.

g. There are additional facilities or equipment or the business has expanded or transferred to a new location.

h. To determine that a licensed or registered establishment is complying with the terms and conditions of the license or registration certificate.

i. There is a strong reason to believe that pertinent provisions of this Order are being violated.

j. When the Director deems necessary to ensure that the quality of the products produced, stored or marketed are in accordance with the standard and criteria of the Bureau.

SECTION 39. Inspection Reports. — The authorized BAI Inspector who has conducted the inspection as required in the preceding sections, shall prepare a written report of the inspection in such form as may be prescribed by the Chief, Laboratory Services Division, submitting said report to the said Chief and the Director, furnishing the owner of the establishment a copy not later than twenty one (21) days after the inspection.

ARTICLE VII

Sampling and Testing

SECTION 40. Compulsory Sampling of Veterinary Biological Products. — Licensed producers and manufacturers of veterinary biological products in the Philippines are required to submit representative samples of each serial or subserial of the biologics they produced or manufactured and registered importers are required to submit representative samples for each serial or sub-serial of every shipment of biologics they imported into the Philippines. Samples of the product may be obtained or bought from the open market from time to time by an authorized Bureau representative and the results of the standard tests done on the samples bought shall be part of the evaluation records of each product. cETDIA 

The Director shall designate the Bureau employee and the employee of the licensee or permittee who shall be authorized to select and collect the representative samples of veterinary biologics to be tested. The designated sample collector shall mark for identification each sample collected before being packaged by the licensee or his employee. Both the Bureau and licensee or permittee shall select/collect comparable sample for similar kind of tests. The samples collected shall be forwarded directly to the Bureau Quality Control Laboratory by either the licensee or the Bureau agent, whichever is actually agreed upon.

SECTION 41. Manner and Method of Sample Selection. — Selection of representative samples of various nature of biologics shall be made at random and as follows:

a. Non-viable liquid biological product — The sample shall either be collected from the bulk product before filling operation or from among the final containers after filling operation.

b. Viable liquid biological product — The samples shall be taken from among the final containers after filling operations. Samples from the bulk containers of the completed product may be collected only when required by the Director under certain conditions or in accordance with the filed outline of production and standard test for that product.

c. Desiccated biological product — If the product has been desiccated in the final containers, the samples shall be randomly selected from among the final product containers. If the product is being desiccated in bulk, collection of samples shall be at the end of the filling operation from among the final containers.

SECTION 42. Quantity or Number of Samples to be Collected from Each Series or Subseries. — Unless otherwise specified by the Director or required in accordance with the filed outline or production, the number of final containers, of samples to be selected from each serial subserial shall be as follows:

a. For both liquid and desiccated products in singledose final containers — The quantity final container shall not be more than twice the number of the tests required.

b. Liquid products in multiple-dose final containers — It shall not exceed two final containers if the completed product does not require any dilution before use; and shall not be more than six (6) final containers if the completed product requires dilution before use.

c. Dissecated product in multiple-dose final containers — The number of sample collected shall not exceed more than six (6) final containers.

d. Multiple-fraction biologics — The number to be collected shall not exceed the total number of the kinds of test required for all the fractions if the product is in single-dose container and not more than six (6) final container for products in multiple-dose containers.

e. Liquid finished product in bulk — The number of samples from each serial and the minimum quantity of the final product to be collected as samples shall be in accordance with the Outline of Production.

SECTION 43. Testing Required Prior to Sale or General Use. — Unless otherwise expressly allowed by the Director, no serial or subserial of a veterinary biological product produced in the Philippines or imported from a foreign source shall be dispensed or released for sale to the public prior to the completion of the prescribed test. SEIDAC

The Director is hereby authorized to cause the testing of veterinary biological products or serial thereof being sold in the open market if there is a strong reason to believe that such products or serial or sub-serial thereof had caused serious damages to animals in the Philippines or the quality is inferior to what has appeared on the label or has been adulterated, contaminated or otherwise has been spoiled.

The final results of each test conducted by the producer or importer and the Bureau Quality Control Laboratory shall be the basis of evaluation of the biological tested, and those with unsatisfactory results shall not be released for sale.

SECTION 44. Quality Control Laboratory Policies in General. — The Quality Control Laboratory of the Bureau shall have the following as general policies:

a. Every product sample collected and submitted to the Quality Control Laboratory shall be tested primarily for purity, safety, potency and sterility. Other types or kinds of quality control tests may be performed only when requested by the importer or producer, or only when ordered by the Director.

b. Both the Bureau and Licensee or permittee laboratories shall use comparable samples of the product for similar kind of test performed.

c. Specific methods and procedures by which a certain biological product shall be evaluated shall be stated in the Outline of Production of that product, otherwise the applicable standard test procedures and methods of the Quality Control Laboratory shall be used.

d. When the initial test is declared a "No" test, that is, the values obtained or results of the test are not conclusive, the test shall be automatically repeated and no further test of the same nature shall be performed after the second test unless that is requested to be done again by the importer or producer in which case the person requesting for the succeeding test shall provide the materials and other laboratory aides needed. If no official request for retesting is received by the laboratory within 30 days from receipt of the last test result, the serial/sub-serial or sample tested shall be considered unsatisfactory.

e. Testing aides and materials not readily available at the Bureau laboratory which are essential for an specific test on a certain product shall be provided by the producer or importer of the said product.

f. When new test methods are developed and approval by the Director, the product shall be tested in accordance with such methods.

g. A potency test or manufacturing procedure written in the filed Outline of Production for a certain biological product shall be considered confidential information by the Laboratory Services Division until two additional product licenses are issued for that type of product or unless the use of the test is authorized by the licensee, in which case, such potency test may be published as part of the standard requirement for that kind of product.

SECTION 45. Exemption from Bureau Test under Certain Conditions. — Certain veterinary biological products may be exempted by the Director from the applicable tests in the standard requirement under the following circumstances:

a. When the product is imported under Special Import Permit and is needed immediately for the control of a serious outbreak of animal disease.

b. When the product is strictly for pure research purposes.

c. When the product is imported for the diagnosis of a suspected exotic animal disease appearing for the first time in the Philippines, provided that such product has been certified by the concerned government agency at the point of the origin to be pure, potent and safe. DHAcET

SECTION 46. Standard Values and Acceptable Levels for Product Evaluation. — The Director is hereby authorized to set criteria and standard values and levels of measurement to set the basis of evaluation of the qualities of veterinary biologies produced, manufactured or marketed in or imported into the Philippines for diagnosis, treatment or prophylaxis of animal diseases; provided that if applicable, the standard values and levels already set forth in an internationally accepted reference or textbook on Veterinary Biologies Quality Control Evaluation shall be adopted as the basis of the Bureau evaluation.

ARTICLE VIII

Penalties, Repealing Provisions and Effectivity

SECTION 47. Penalties. — Any person violation any of the provisions of Act No. 3101 and Republic Act No. 1071 and of this Order or any other rules and regulations that may be issued in accordance with the said laws shall be deemed guilty of misdemeanor and shall be punished by imprisonment or fine or both as the Court may decide in accordance with the penal provisions of either Act No. 3101 or Republic Act No. 1071, whichever is applicable.

SECTION 48. Repealing Provision. — All laws, rules and regulations or parts thereof in conflict with the provisions of this Order are hereby repealed and modified accordingly.

SECTION 49. Effectivity. — This Administrative Order shall take effect immediately.

(SGD.) ARTURO R. TANCO, JR.MinisterMinistry of Agriculture

RECOMMENDING APPROVAL:

(SGD.) SALVADOR H. ESCUDERO IIIDirector & Concurrently Assistant Secretary of Livestock, Ministry of Agriculture