October 7, 1991
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 the Secretary of Agriculture and Natural Resources to
promulgate regulations for the preparation, sale, traffic in, shipment and importation of
viruses, sera, toxins, or analogous products used for the treatment of domestic animals,
the following requirements for the registration of veterinary drugs and products are
hereby promulgated for the information, guidance and compliance of all concerned:
Section 1. DEFINITION OF TERMS:
For purposes of these Rules and Regulations, the following definitions 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 Food and Drugs (BFAD)/Bureau of Animal
Industry (BAI).
1.2 “Veterinary Drugs and Products” refer to any substance, including biological
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 physiological functions or behaviors.
1.3 “Veterinary Drug for General Use” refers to a veterinary drug approved for sale
for animal use without restriction other than the usual.
1.4 “Veterinary Drug for Restricted Use” refers to a veterinary drug approved for
sale for animal use under certain conditions.
Section 2. GENERAL STANDARDS
2.1 Establishments applying to register a veterinary drug and product are required to
fully disclose all pertinent documentation and information regarding the veterinary
drug and product. Failure to fully disclose material information about the veterinary
drug and product is a ground for disapproval 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 of
specification of the veterinary drug and product proposed to appear on the label, i.e.
formulation, dosage form, strength, therapeutic indications and manufacturer. Any
change in any of the above specification shall require a new registration.
2.3 Action on registration application shall include the classification of the veterinary
drugs and products among each of the classification categories defined in Section 3
below. Any change in classification shall require a new registration. However, any
change in the name of the same manufacturer shall 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 be made after proper
consultation with the parties concerned. Revised standards and evaluation methods
shall be made applicable to all covered veterinary drugs and products as appropriate.
2.5 Only establishments with valid license to operate required under joint
Administrative Orders No. 100, Department of Agriculture and No. 138, Department of
Health, series 1990 can apply to register veterinary drug and products.
Section 3. CLASSIFICATION
All veterinary drugs and products shall be evaluated and registered on the basis
of specific requirements and standards pertinent to the classification of such veterinary
drugs and products. All registered veterinary drugs and products shall be classified in
terms of each of the following categories.
3.1 Number of Active Ingredients
3.1.1 Single Active Ingredients
3.1.2 Fixed-dose combination of two or more active ingredients
3.2 Available scientific and product’s evidence and experience on the
veterinary
drug use
3.2.1 “Investigational Veterinary Drugs and Products” refer to any new chemical or
structural modification of Tried and Tested or Established Veterinary Drug and Product
proposed to be used for a specific therapeutic indication. Investigational veterinary
drug and product need further clinical pharmacology studies (Phase I, II, or III) to
determine their safety and efficacy, and meet the requirements of new veterinary drugs
and products.
3.2.2 “New Veterinary Drug and Product” refer to any new chemical or structural
modification of Tried and Tested or Established Veterinary Drugs and Products
proposed to be used for a specific therapeutic indication, which have undergone
adequate clinical pharmacology Phase I, II, and III studies but which need further
Phase IV Clinical Pharmacology studies before they can be given regular registration.
3.2.3 “Tried and Tested Veterinary Drugs and Products” refers to any veterinary drug
and product which have been used for at least five (5) years.
3.2.4 “Established Veterinary Drug and Product” refers to veterinary drug and product
the safety and efficacy of which have been demonstrated 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 Tested or Established
Veterinary Drug and Product” includes any or all the following:
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 dose combination of two or more
ingredients.
3.3 Pharmacologic/therapeutic category as specified in the Philippine National
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
3.4.1 Imported as finished
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 and product
3.5.1 Brand and patented
3.5.2 Branded and off-patent
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 and dispensing
(Annex B – List B)
Section 4. INITIAL PRODUCT REGISTRATION
4.1 Application
Any establishment applying for the initial registration of veterinary drug and
product shall file an application under oath. The application shall be 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 and product 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 and product. The
evaluation shall cover physical, chemical and biological tests for quality, purity, safety,
potency or efficacy.
4.4 Assessment of Findings
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 a recommendation regarding
action on the registration application.
4.5 Action on Registration Application
BFAD/BAI action on the registration application consists of the following
possible courses:
4.5.1 Disapproval of application for failure to meet standards of quality, 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 variable duration 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 to annual
evaluation.
4.5.6 Approval for restricted use for a period of five (5) years subject to annual
evaluation.
4.6 Grounds for Disapproval
The two (2) types of disapproval action (4.5.1 and 4.5.2) shall be taken on the
following grounds.
4.6.1 Review of submitted data or testing of submitted samples indicate that the
product does not meet current BFAD/BAI and or manufacturer’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 registration.
4.7 Grounds for Limited Approval
The two (2) types of limited approval actions (4.5.3 and 4.5.4) shall be taken on the
following grounds:
4.7.1 An investigational Veterinary Drug and Product Application shall be
approved when the following are met.
4.7.1.1 The results of prior laboratory animal studies are found adequate
to warrant further clinical pharmacology studies (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 in experimental design.
4.7.1.3 The clinical investigator who shall undertake the study is
competent and reliable and the facilities and control used for the study are adequate.
4.7.2 A New Veterinary Drug and Product Application shall be approved for
post-marketing surveillance when the following are met.
4.7.2.1 The results of prior laboratory animal studies are found adequate
and the clinical pharmacology Phase I, II and III show that the New Veterinary Drug
and Product are safe and efficacious when used for their therapeutic indication.
4.8 Grounds for Approval
The two (2) types of approval actions (4.5.5 and 4.5.6) shall be taken on the following
grounds.
4.8.1 Review of submitted data and testing of submitted samples indicate that
the application is supported by substantial evidence showing the veterinary drug and
product to be safe, efficacious and good quality.
4.8.2 Applicant demonstrated that the methods used in as well as the facilities
and controls used for, manufacture of the veterinary drug 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 correct representation of
such veterinary drug and product and conforms with current labeling requirements.
Section 5. RENEWAL OF REGISTRATION
5.1 Only veterinary drugs and products registered for general and restricted use
are eligible for renewal of registration.
5.2 Application for renewal of registration shall be made on a form
promulgated by BFAD/BAI.
5.3 Renewal application shall be reviewed and evaluated on the basis of the
veterinary drug and product and the applicant meeting the current BFAD/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 selected period of registration, shall be
charged:
6.1 Initial Registration
6.1.1 Investigational – P 1,000 per year or any fraction thereof
veterinary drug and
product application
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
Veterinary Drug or
Product
6.1.6 Branded Generic – P 2,000 for 2 years or P 5,000 for 5 years + cost of
laboratory analysis
Product
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 contrary to law or
unconstitutional, other provisions which are not affected hereby shall continue to be in
force in effect.
Section 9. REPEALING CLAUSE
All administrative orders, rules and regulations and other administrative
issuance or parts thereof inconsistent with the provisions of this Administrative Order
are hereby repealed or modified accordingly.
Section 10. EFFECTIVITY
This regulation shall take effect fifteen (15) days after its publication in a
newspaper of general circulation.
(Sgd.) SENEN C. BACANI (Sgd.)
ALFRED R. A. BENGZON, M.D.
Secretary of
Health Secretary of Health
ANNEX A
(LIST A)
LIST OF PHARMACEUTICAL PRODUCTS CLASSIFIED AS PROHIBITED
DRUGS OR REGULATED DRUGS BY THE DANGEROUS DRUGS BOARD
I. Prohibited Drugs
1. ALFENTANIL - Rapifen Injectable
2. CODEINE (as sulfate) - Codeine Sulfate H.T.
- Codeine Sulfate T.T.
3. CODEINE (as phosphate) - Dolo-Adamon Suppository
- Dolo-Adamon Tablet
4. DIHYDROCODEINE - NOT AVAILABLE IN THE
MARKET
5. FENTANYL (as citrate) - Sublimaze Injectable
6. FENTANYL (as citrate) /
Droperidol - Innovar
7. HYDROCODONE
(DIHYDROCODEINONE) - Deka Syrup
(as bitartrate) - Raminon Syrup
8. HYDROCODONE
(DIHYDROCODEINONE) - Tussinex Suspension
9. HYDROCODONE
(DIHYDROCODEINONE) -Codevite Syrup
(as bitartrate) plus Pyrilamine (as
maleate) /
Sodium Citrate / Ammonium
Chloride / Potassium
Guaiacolsulfonate
10. HYDROCODONE
(DIHYDROCODEINONE) / - Endotussin Syrup
(as bitartrate) plus Pyrilamine (as
maleate) /
Homatropine (as methylbromide)
/
Phenylephrine (as hydrochloride)
/
Ammonium Chloride
11. MORPHINE (as sulfate) - Morphine Sulfate H.T.
- Morphine Sulfate Ampul
- Morphine Sulfate Tablet
12. MORPHINE (as sulfate) /
Atropine - Morphine with Atropine
13. OPIUM - Brown Mixture Tablet
- Brown Mixture Liquid
14. OPIUM / ALCOHOL - Elixir Paregoric
15. PETHIDINE (MEPERIDINE) - Demerol Ampul
- Demerol Tablet
- Demerol Vial
II. Regulated Drugs
A. Available in the Market
1. AMOBARBITAL (as sodium) - Amytal Sodium
Ampul
- Amytal Sodium
Capsule
- Amytal Sodium
Tablet
2. AMPHETAMINE - Benzedrine Tablet
- Daprisal Tablet
3. APROBARBITAL, BARBITAL, AND - Plexonal
PHENOBARBITAL
4. CHLORAL HYDRATE - Noctec
5. DEXAMPHETAMINE - Dexedrine Spansule
6. EPHEDRINE (excluding exempt
preparations)
7. ETHINAMATE - Valamin Tablet
8. FLUNITRAZEPAM - Rohypnol
9. NITRAZEPAM - Mogadon
10. PARALDEHYDE - Paraldehyde
Ampule
11. PENTAZOCINE (as hydrochloride) - Sosegon Tablet
12. PENTAZOCINE (as base) - Sosegon Ampule
13. PENTHOTAL (as sodium) - Penthotal Sodium
Vial
- Thiopental Sodium
Vial
14. PROPOXYPHENE (as hydrochloride) - Doloxene Palin
Tablet
15. PROPOXYPHENE (as napsylate), - Doloxene
Compound-65
Aspirin, and Caffeine
16. PROPOXYPHENE (as napsylate) - Dologesic - 32
/ Paracetamol
17. PSEUDOEPHEDRINE (excluding
exempt preparations)
Local suppliers no longer carry these drugs but are still available in some drugstores
and hospital pharmacies.
B. Not Available in the Market
1. AMOBARBITAL /
DEXAMPHETAMINE
- Dexamyl Spansule
No.1
2. BUTABARBITAL - Butisol Sodium
Tablet
- Circuline Forte
Tablet
3. ETHCHLORVYNOL - Placidyl Capsule
4. HYDROCODONE
(DIHYDROCODEINONE) / - Calcidrine Syrup
PENTOBARBITAL
5. MECLOQUALONE - Nubarene Tablet
6. METHAMPHETAMINE - Desoxyn Tablet
7. METHAQUALONE /
Diphenhydramine - Mandrax Tablet
(as hydrochloride)
8. METHYLPRYLON - Noludar Tablet
9. PENTOBARBITAL (as sodium) - Nembutal Sodium
Vial
10.PIPRADROL - Gadexyl Tablet
11.SECOBARBITAL - Seconal Sodium
Capsule
Local suppliers no longer carry these drugs but are still available in some drugstores
and hospital pharmacies.
ANNEX B
(LIST B)
LIST OF VETERINARY DRUGS AND PRODUCTS REQUIRING STRICT
PRECAUTION IN PRESCRIBING, DISPENSING AND USE
1. ACEPROMAZINE : TABLET / INJECTABLE
2. AMINOPHYLLINE : SUPPOSITORY / TABLET
3. AMITRAZ : POUR ON
4. AMPHOTERICIN B : INJECTABLE
5. AZAPERONE : INJECTABLE
6. BETAMETHASONE : TABLET
7. BUNAMIDINE : TABLET
8. CARBADOX : PREMIX
9. CHLORAMBUCIL : TABLET
10. CHLORAMPHENICOL : CAPSULE / INJECTABLE
11. CHLORPROPAMIDE : TABLET
12. COLISTIN : INJECTABLE
13. CYCLOPHOSPHAMIDE : TABLET
14. DEXAMETHASONE : TABLET
15. DEXAMETHASONE ACETATE: INJECTABLE
16. DIAZEPAM : TABLET
17. DICHLORVOS : CAPSULE / GRANULES
18. DIETHYLESTILBESTROL
(DES) : INJECTABLE
:
19. DIGITOXIN : TABLET
20. DIGOXIN : TABLET
21. DIHYDROSTREPTOMYCIN : INJECTABLE
22. DIMETRIDAZOLE : INJECTABLE
23. DIMINAZINE : INJECTABLE
24. EPINEPHRINE : INJECTABLE
25. ERYTHROMYCIN : INJECTABLE
26. ESTROGENS, CONJUGATED : INJECTABLE
27. ETHINYLESTRADIOL : TABLET
28. ETHOSUXIMIDE : CAPSULE
29. FURAZOLIDONE : SUSPENSION / TABLET
30. FUROSEMIDE : TABLET / INJECTABLE
31. GENTAMACIN : INJECTABLE
32. HALQUINOL : PREMIX
33. HYDROCHLOROTHIAZIDE : TABLET
34. HYDROCORTISONE : INJECTABLE
35. IMIDOCARB : INJECTABLE
36. INSULIN : INJECTABLE
37. IVERMECTIN : TABLET / INJECTABLE
38. KETAMINE : INJECTABLE
39. LASALOCID : PREMIX
40. LEVAMISOLE : INJECTABLE
41. LINDANE : POUR ON
42. LORAZEPAM : ORAL
43. MELARSONYL : INJECTABLE
44. MENADIONE : TABLET
45. MENADIONE SODIUM
BISULFATE : TABLET
46. MEPHENYTOIN : TABLET
47. METHDILAZINE
HYDROCHLORIDE : TABLET
48. METHOTREXATE : TABLET
49. METHYLERGOMETRINE
(METHYLERGONOVINE)
MALEATE : TABLET
50. METRONIDAZOLE : TABLET
51. MONENSIN : PREMIX
52. NEOMYCIN : INJECTABLE
53. NICLOSAMIDE : TABLET
54. NITROFURANTOIN : CAPSULE/SUSPENSION
TABLET
55. OLAQUINDOX : PREMIX
56. OUABAIN : INJECTABLE
57. OXYTETRACYCLINE (LONG-
ACTING) : INJECTABLE
58. OXYTOCIN : INJECTABLE
59. PANCURONIUM : INJECTABLE
60. PERPHENAZINE : SUPPOSITORY / SYRUP / TABLET /
CR TABLET
61. PHENYLBUTAZONE : CAPSULE / TABLET
62. PHENYTOIN : SUSPENSION
63. PHENYTOIN SODIUM,
EXTENDED : CAPSULE
64. PHENYTOIN SODIUM,
PROMPT : CAPSULE
65. PRAZIQUANTEL : TABLET
66. PROBENECID : TABLET
67. PROCAINAMIDE
HYDROCHLORIDE : CAPSULE/TABLET/CR TABLET
68. PROPIONYL
PHENOTHIAZINE : INJECTABLE
69. PROSTAGLANDIN F2 ALPHA : INJECTABLE POWDER
70. PYRAZINAMIDE : TABLET
71. QUINIDINE SULFATE : CAPSULE/TABLET/CR TABLET
72. SALINOMYCIN : PREMIX
73. SPIRONOLACTONE : TABLET
74. STREPTOMYCIN : INJECTABLE
75. SUCCINYLCHOLINE : INJECTABLE
76. SULFADIAZINE;
SULFAMERAZINE
SULFAMETHAZINE : TABLET
77. SULFAMETHIZOLE : SUSPENSION / TABLET
78. SULFISOXAZOLE : SUSPENSION / TABLET
79. SURAMIN : INJECTABLE
ANNEX C
REQUIREMENTS FOR REGISTRATION
A. General Requirements
1. License To Operate of the veterinary drug and product manufacturer, trader,
distributor / importer, distributor / exporter.
2. Technical data which shall include:
2.1 Physical description of the veterinary drug and product.
2.2 Complete formulation and technical specifications for the raw materials 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 stability including 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 active ingredient(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 other labeling
materials such as inserts brochures, etc.
5. Relevant literature and/or scientific evidence based on local or foreign studies to
show safety, efficacy, potency, and therapeutic value of the veterinary drug and
product. Local studies must be based on protocols acceptable to BFAD / BAI.
B. Specific Requirements
1. Investigational Veterinary Drug and Product
1.1 Veterinary Medical Director / Officer registered with BFAD / BAI.
1.2 Laboratory Animal Studies
1.2.1 Acute toxicity
1.2.2 Sub-chronic toxicity
1.2.3 Teratogenicity
1.2.4 Other studies, e.g. carcinogenecity
1.3 Clinical Pharmacology Studies
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. New Veterinary Drug and Product
2.1 Veterinary Medical Director / Officer registered with BFAD / BAI.
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 (EIA) when
applicable.
2.4 Phase IV Clinical Use
2.4.1 Post-marketing surveillance
3. Tried and Tested Veterinary Drug and Product
3.1 Dissolution test for solid oral dosage forms when applicable.
3.2 Bioavailability / bioequivalence study for certain veterinary drugs and products
determined by BFAD /
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 when applicable.
5. Pharmaceutical and Therapeutic innovation of Tried and Tested or Established
Veterinary Drug and Product.
5.1 Veterinary Medical Director / Officer registered with BFAD / BAI.
5.2 Dissolution test for solid dosage forms when applicable.
5.3 Bioavailability / bioequivalence for certain drugs as determined by BFAD/BAI
when applicable.
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. Dangerous Drugs
1.1 Certificate of clearance from the Dangerous Drug Board.
2. Branded Drugs
2.1 Certificate of trademark from the Bureau of Patents
2.2 Certificate of brand name clearance issued by BFAD/BAI
3. Imported Finished Products
3.1 Certificate of Free Sale of Veterinary Drug and Product in country of origin
authenticated by the territorial Philippine Consulate and/or
3.2 Certification from FAO/WHO International Certification Scheme for
manufacturers or equivalent.
4. Locally-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 the FAO/WHO.
4.2 License To Operate of the manufacturer, if different from applicant.
4.3 Copy of the contract between applicant and manufacturer, when applicable.
4.4 Certificate of Fee Sale for registration of any veterinary drug and product
containing said ingredient or raw material in country 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 material(s).
5.2 License To Operate of the manufacturer of the finished product, if different from
applicant.
5.3 Copy of contract between applicant and manufacturer of the finished products,
when applicable.
Copyright © 2007 Philippine Veterinary Medical Association.
www.pvma.com.ph