DEPARTMENT OF AGRICULTURE
Administrative Order No. 33 Series of 1991 DEPARTMENT OF HEALTH Administrative Order No. 111-A Series of 1991
SUBJECT : RULES AND REGULATIONS ON REGISTRATION OF VETERINARY DRUGS AND PRODUCTS
Pursuant to R.A. No. 3720, as amended by Executive Order No. 175 otherwise known as the “Foods, Drugs and Devices, and Cosmetics,R.A. No. 6675, otherwise known as the “Generics Act of 1988” R.A. 1556,biologics and medicinal preparations and R.A. 3101, an Act authorizing the Director of the Bureau of Animal Industry, subject to the approval of theSecretary of Agriculture and Natural Resources to promulgate regulationsfor the preparation, sale, traffic in, shipment and importation of viruses, sera, toxins, or analogous products used for the treatment of domestic animals,the fol owing requirements for the registration of veterinary drugs andproducts are hereby promulgated for the information, guidance andcompliance of all concerned:
Section 1.DEFINITION OF TERMS:
For purposes of these Rules and Regulations, the followingdefinitions are adopted:
1.1 “Registration” refers to the process of approval for the manufacture,importation, exportation, sale, offer for sale, distribution, labeling, advertising or transfer of veterinary drugs and products obtaining active ingredients(s)known chemical structures and properties determined to be safe,efficacious, and of good quality according to standards of Bureau of Foodand Drugs (BFAD)/Bureau of Animal Industry (BAI).
1.2 “Veterinary Drugs and Products” refer to any substance, includingbiological products, applied or administered to food producing, companion,aquatic, laboratory and exotic animals, whether used for therapeutic, prophylactic or diagnostic purposes or for modification of physiologicalfunctions or behaviors.
1.3 “Veterinary Drug for General Use” refers to a veterinary drugapproved for sale for animal use without restriction other than the usual.
1.4 “Veterinary Drug for Restricted Use” refers to a veterinary drugapproved for sale for animal use under certain conditions.
Section 2.GENERAL STANDARDS
2.1 Establishments applying to register a veterinary drug and product arerequired to fully disclose all pertinent documentation and information regarding the veterinary drug and product. Failure to fully disclose materialinformation about the veterinary drug and product is a ground fordisapproval of registration application and one of the bases for withdrawal of the establishment’s license to operate.
2.2 Action on registration application shall be based on the complete set ofspecification of the veterinary drug and product proposed to appear on thelabel, i.e. formulation, dosage form, strength, therapeutic indications and manufacturer. Any change in any of the above specification shall require anew registration.
2.3 Action on registration application shall include the classification of theveterinary drugs and products among each of the classification categories defined in Section 3 below. Any change in classification shall require a newregistration. However, any change in the name of the same manufacturershall require proper notification of BFAD/BAI.
2.4 The standards of veterinary drug and product registration as well as the methods of evaluation are subject to revisions. Any major change shall bemade after proper consultation with the parties concerned. Revisedstandards and evaluation methods shall be made applicable to all coveredveterinary drugs and products as appropriate.
2.5 Only establishments with valid license to operate required under jointAdministrative Orders No. 100, Department of Agriculture and No. 138,Department of Health, series 1990 can apply to register veterinary drug andproducts.
Section 3.CLASSIFICATION
All veterinary drugs and products shall be evaluated andregistered on the basis of specific requirements and standards pertinent tothe classification of such veterinary drugs and products. All registered veterinary drugs and products shall be classified in terms of each of thefollowing categories.
3.1.2 Fixed-dose combination of two or more active ingredients
3.2 Available scientific and product’s evidence and experience on theveterinary drug use
3.2.1 “Investigational Veterinary Drugs and Products” refer to any new
chemical or structural modification of Tried and Tested or EstablishedVeterinary Drug and Product proposed to be used for a specific therapeutic indication. Investigational veterinary drug and productneed further clinical pharmacology studies (Phase I, II, or III) todetermine their safety and efficacy, and meet the requirements of newveterinary drugs and products.
3.2.2 “New Veterinary Drug and Product” refer to any new chemicalor structural modification of Tried and Tested or EstablishedVeterinary Drugs and Products proposed to be used for a specifictherapeutic indication, which have undergone adequate clinical pharmacology Phase I, II, and III studies but which need further PhaseIV Clinical Pharmacology studies before they can be given regularregistration.
3.2.3 “Tried and Tested Veterinary Drugs and Products” refers to anyveterinary drug and product which have been used for at least five (5)years.
3.2.4 “Established Veterinary Drug and Product” refers to veterinarydrug and product the safety and efficacy of which have beendemonstrated through long years of general use and can be found in current official USP-NF, and other internationally-recognized pharmacopeias.
3.2.5 “Pharmaceutical or Therapeutic Innovation of Tried and Testedor Established Veterinary Drug and Product” includes any or all thefollowing:
3.2.5.1 An innovation involving use for new indication(s)
3.2.5.2 An innovation involving a new mode of administration
3.2.5.3 An innovation involving a new dosage form
3.2.5.4 An innovation involving a new fixed dosecombination of two or more ingredients.
3.3 Pharmacologic/therapeutic category as specified in the PhilippineNational Veterinary Drug Formulary (See joint A.O. DOH-No. 100 and DA-No. 138 s. 1990)
3.4 Source or circumstance of veterinary drug and product production
3.4.2 Locally-manufactured from imported materials
3.4.3 Locally-manufactured from local materials
3.5 Brand identification and patent protection of the veterinary drug andproduct
3.5.3 Unbranded and off-patent (generic veterinary drug and product)
3.6 Prescribing and dispensing regulations applicable
3.6.1 Over-the-counter (OTC) Veterinary Drugs and Products or Non-prescription Veterinary Drugs and Products or Self Service (SS) Veterinary Drugs and Products.
3.6.2 Ethical or Prescription Veterinary Drugs and Products
3.6.3 Dangerous Drugs (Annex A – List A)
3.6.4 Veterinary Drugs requiring strict precaution in prescribing anddispensing (Annex B – List B)
Section 4.INITIAL PRODUCT REGISTRATION
Any establishment applying for the initial registration of veterinarydrug and product shall file an application under oath. The application shallbe in a form promulgated by BFAD/BAI and supported by the documents and requirements listed in Annex C.
4.2 Evaluation by Review of Submitted Data
BFAD/BAI evaluates the submitted data. First, it determines if the
data presented are complete. If not complete, applicant is requested to submit additional data or undertake needed animal or clinical studies. Second, it determines if on the basis of data submitted, veterinary drug andproduct meet current BFAD/BAI standards for quality, purity, safety, efficacy,potency or therapeutic value.
4.3 Evaluation by Testing of Submitted Samples
BFAD/BAI evaluates submitted samples of veterinary drug andproduct. The evaluation shall cover physical, chemical and biological testsfor quality, purity, safety, potency or efficacy.
At any point during the evaluation, BFAD/BAI may conclude that the
veterinary drug and product do not meet the standards of quality, safety,potency, purity, efficacy and therapeutic value. In such case, the application shall be denied. At the end of the evaluation, BFAD/BAI shall arrive at arecommendation regarding action on the registration application.
BFAD/BAI action on the registration application consists of the
4.5.1 Disapproval of application for failure to meet standards ofquality, safety, potency, efficacy, purity or therapeutic value.
4.5.2 Disapproval of application for lack of qualification required from veterinary drug and product establishment.
4.5.3 Approval for investigational use over a period of variableduration depending on the BFAD/BAI accepted protocol.
4.5.4 Approval for post-marketing surveillance for a period of 3 years subject to annual evaluation.
4.5.5 Approval for general use for a period of five (5) years subject toannual evaluation.
4.5.6 Approval for restricted use for a period of five (5) years subjectto annual evaluation.
The two (2) types of disapproval action (4.5.1 and 4.5.2) shall be
4.6.1 Review of submitted data or testing of submitted samples
indicate that the product does not meet current BFAD/BAI and ormanufacturer’s guaranteed standards of identity, purity, strength, quality, safety, potency, efficacy or therapeutic value.
4.6.2 The labelling material of the veterinary drug and product is
false and misleading or does not conform with current labelling requirements.
4.6.3 Applicant materially misrepresented or withheld significant data
or information regarding the veterinary drug and product.
4.6.4 Applicant failed to comply with the requirements for
The two (2) types of limited approval actions (4.5.3 and 4.5.4) shall
4.7.1 An investigational Veterinary Drug and Product Applicationshall be approved when the following are met.
4.7.1.1 The results of prior laboratory animal studies arefound adequate to warrant further clinical pharmacologystudies (phase I, II and/or III)
4.7.1.2 The protocol submitted for the clinical pharmacology studies is found to be adequate and scientifically sound inexperimental design.
4.7.1.3 The clinical investigator who shall undertake thestudy is competent and reliable and the facilities and controlused for the study are adequate.
4.7.2 A New Veterinary Drug and Product Application shall beapproved for post-marketing surveillance when the following are met.
4.7.2.1 The results of prior laboratory animal studies arefound adequate and the clinical pharmacology Phase I, II and III show that the New Veterinary Drug and Product aresafe and efficacious when used for their therapeuticindication.
The two (2) types of approval actions (4.5.5 and 4.5.6) shall be taken
4.8.1 Review of submitted data and testing of submitted samplesindicate that the application is supported by substantial evidence
showing the veterinary drug and product to be safe, efficacious andgood quality.
4.8.2 Applicant demonstrated that the methods used in as well asthe facilities and controls used for, manufacture of the veterinarydrug and product are adequate to assure their identity, strength,quality, purity, safety, potency, efficacy and therapeutic value.
4.8.3 The label of the veterinary drug and product is a correctrepresentation of such veterinary drug and product and conformswith current labeling requirements.
Section 5.RENEWAL OF REGISTRATION
5.1 Only veterinary drugs and products registered for general and restricteduse are eligible for renewal of registration.
5.2 Application for renewal of registration shall be made on a formpromulgated by BFAD/BAI.
5.3 Renewal application shall be reviewed and evaluated on the basis ofthe veterinary drug and product and the applicant meeting the currentBFAD/BAI and manufacturers guaranteed standards of identity, purity,strength, quality, safety, potency, efficacy and therapeutic value.
Section 6.SCHEDULE OF FEES
Upon application for registration of a veterinary drug and product,
the following non-refundable fees to be paid in full for the entire selectedperiod of registration, shall be charged:
6.1.1 Investigational – P 1,000 per year or any fraction thereof veterinary drug and
6.1.2 New veterinary – P 6,000 for 3 years + cost of laboratory analysis
drug and product application for mar- keting-surveilance
6.1.3 New veterinary – P 4,000 for 2 years or P10,000 for 5 years + cost of laboratory analysis
drug and product application for gene- ral or restricted use
6.1.4 New pharmaceu - P 4,000 for 2 years or P10,000 for 5 years + cost of laboratory analysis
tical or therapeutic innovation of tried and tested or estab- lished veterinary drug or product
6.1.5 Unbranded Generic – P 1,000 for 2 years or P 2,500 for 5 years + cost of laboratory analysis
6.1.6 Branded Generic – P 2,000 for 2 years or P 5,000 for 5 years + cost of laboratory analysis
6.2 Renewal of Registration – P 1,500 for 5 years + cost of laboratory analysis
Section 7.APPEAL
Disapproved application(s) may be appealed to the Secretary of
Health / Secretary of Agriculture for reconsideration.
Section 8.SEPARABILITY CLAUSE
In case any provision of this administrative order is declared contraryto law or unconstitutional, other provisions which are not affected herebyshall continue to be in force in effect.
Section 9.REPEALING CLAUSE
All administrative orders, rules and regulations and otheradministrative issuance or parts thereof inconsistent with the provisions ofthis Administrative Order are hereby repealed or modified accordingly.
Section 10.EFFECTIVITY
This regulation shall take effect fifteen (15) days after its publication
(Sgd.) SENEN C. BACANI (Sgd.) ALFRED R. A. BENGZON, M.D. Secretary of Agriculture Secretary of Health
LIST OF PHARMACEUTICAL PRODUCTS CLASSIFIED AS PROHIBITED DRUGS OR REGULATED DRUGS BY THE DANGEROUS DRUGSBOARD
I. Prohibited Drugs
(DIHYDROCODEINONE) / (as bitartrate) plus
Pyrilamine (as maleate) / Homatropine (as
15. PETHIDINE (MEPERIDINE) - Demerol Ampul
II. Regulated Drugs
11. PENTAZOCINE (as hydrochloride) - Sosegon Tablet
16. PROPOXYPHENE (as napsylate) - Dologesic - 32
Local suppliers no longer carry these drugs but are still available in somedrugstores and hospital pharmacies.
Local suppliers no longer carry these drugs but are still available in somedrugstores and hospital pharmacies.
LIST OF VETERINARY DRUGS AND PRODUCTS REQUIRING STRICT
PRECAUTION IN PRESCRIBING, DISPENSING AND USE
REQUIREMENTS FOR REGISTRATION
1. License To Operate of the veterinary drug and productmanufacturer, trader, distributor / importer, distributor / exporter.
2.1 Physical description of the veterinary drug and product.
2.2 Complete formulation and technical specifications for the rawmaterials and finished product.
2.3 Process of manufacturing including facilities and control used in the manufacturing and packaging of the veterinary drug and product.
2.4 Description of all quality control tests performed stabilityincluding Dissolution Test, when applicable, and results obtained.
2.4.1 For antibiotic products, results of batch analysis.
2.5 Certificate of analysis and assay procedures for activeingredient(s) and degradation product(s) if any.
2.6 Complete stability studies under local conditions
3. Samples and corresponding reference standards.
4. Two copies of labels or specimens of the proposed label and otherlabeling materials such as inserts brochures, etc.
5. Relevant literature and/or scientific evidence based on local orforeign studies to show safety, efficacy, potency, and therapeuticvalue of the veterinary drug and product. Local studies must bebased on protocols acceptable to BFAD / BAI.
1. Investigational Veterinary Drug and Product
1.1 Veterinary Medical Director / Officer registered with BFAD /
1.2.4 Other studies, e.g. carcinogenecity
1.3.1 Phases I and II tolerance and efficacy studies.
1.3.2 Phase III clinical trial for target animal species.
1.3.2.1 Local 1.3.2.2 Foreign when applicable
2.1 Veterinary Medical Director / Officer registered with BFAD /
2.2 Results of laboratory animal and clinical studies as required
in Section 1.2 and 1.3 of this Annex and results of carcinogencity test if required by BFAD/BAI.
2.3 Results of Ecological or Environmental Impact Assessment
3. Tried and Tested Veterinary Drug and Product
3.1 Dissolution test for solid oral dosage forms when
3.2 Bioavailability / bioequivalence study for certain veterinary
BAI when applicable. 3.3 Local clinical trial to determine effective therapeutic dose
range in target animals when applicable.
4. Established Veterinary Drug and Product
4.1 Dissolution test for solid dosage forms when applicable.
4.2 Bioavailability / bioequivalence study for certain veterinary
drugs and products as determined by BFAD / BAI whenapplicable.
5. Pharmaceutical and Therapeutic innovation of Tried and Tested or
Established Veterinary Drug and Product.
5.1 Veterinary Medical Director / Officer registered with BFAD /
5.2 Dissolution test for solid dosage forms when applicable.
Bioavailability / bioequivalence for certain drugs as
5.4 Local clinical and non-clinicals trial to test efficacy, potency,
and safety of the therapeutic innovation, when applicable.
C. Additional Requirements for Certain Categories.
1.1 Certificate of clearance from the Dangerous Drug Board.
2.1 Certificate of trademark from the Bureau of Patents
2.2 Certificate of brand name clearance issued by BFAD/BAI
3.1 Certificate of Free Sale of Veterinary Drug and Product in
country of origin authenticated by the territorial PhilippineConsulate and/or
Certification from FAO/WHO International Certification
4. Local y-manufactured Products from Imported Materials.
4.1 Certificate of quality of imported raw materials from the Drug
Regulatory Authority of the country of origin from theFAO/WHO.
4.2 License To Operate of the manufacturer, if different from
4.3 Copy of the contract between applicant and manufacturer,
4.4 Certificate of Fee Sale for registration of any veterinary drug
and product containing said ingredient or raw material incountry of origin authenticated by the territorial Philippine Consulate.
5. Locally-manufactured Products from Local Materials.
5.1 License To Operate of the manufacturer of the local raw
5.2 License To Operate of the manufacturer of the finished
5.3 Copy of contract between applicant and manufacturer of
Copyright 2007 Philippine Veterinary Medical Association.
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4.3 Copy of the contract between applicant and manufacturer,
4.4 Certificate of Fee Sale for registration of any veterinary drug
and product containing said ingredient or raw material incountry of origin authenticated by the territorial Philippine Consulate.
5. Locally-manufactured Products from Local Materials.
5.1 License To Operate of the manufacturer of the local raw
5.2 License To Operate of the manufacturer of the finished
5.3 Copy of contract between applicant and manufacturer of
Copyright 2007 Philippine Veterinary Medical Association.