VETERINARY PRODUCT REGISTRATION

Transcription

1 VETERINARY PRODUCT REGISTRATION Biologics & Veterinary Drug Control Unit Department of Veterinary Services, Malaysia

2 PURPOSE OF REGISTRATION To regulate the sale and use of biologics for animal use in the country. To ensure the safety of all biologics that comes into the country

3 DEFINITION OF VETERINARY BIOLOGICS Any viruses, serums, toxins, antitoxins, vaccines, live microorganisms, killed microorganisms, and the antigenic or immunizing component of micro-organisms intended for use in the diagnosis, treatment, or prevention of diseases of animals, for the purpose of research in animals

4 LEGISLATION Animal Act 1953 (Revised 2006) Section 30 Possession The Director General may issue licenses permitting the holder of such license to possess live cultures or vaccines and to inoculate animals or birds with such culture or vaccine

5 Section 84 Importation Importation of any living noxious insect, or any living pest, or any living disease germ or virus or any bacterial culture, of a nature harmful or dangerous to animals or birds

6 VETERINARY BIOLOGICS Blood or blood component (serum, plasma, antibody, antigen, etc) Microorganism (probiotic/ yeast/ vaccines/ test kit) Enzymes (sourced from animals/ bacteria) Hormones Tissue/ cell Animal feed (which contain microorganism/ enzyme/ hormone)

7 VETERINARY PRODUCT REGISTRATION DVS Department of Veterinary Service Biologics NPRA National Pharmaceutical Regulatory Agency Scheduled Poison Non poison/ OTC DOA Department of Agriculture Pesticide

8 REGISTRATION OF VETERINARY PRODUCTS Products containing; 1) Scheduled Poison (as in First Scheduled of Poison Act 1952) 2) Non Poison/ OTC 3) Health/ Dietary Supplement e.g. Vitamins, minerals, amino acids 4) Herbal/ Natural Ingredients 5) Herbal/ Natural Pesticides for External use (not listed under Pesticides as listed under First Schedule of Pesticide Act 1974) Regulated under National Pharmaceutical Regulatory Agency (NPRA), MOH Biologic products; 1) Vaccines 2) Enzymes 3) Probiotics 4) Yeasts 5) Hormones (Natural/ Synthetic) 6) Animal Feed/ Feed Additives/ Premixes (containing enzymes, beneficial bacteria, yeast) Regulated under Department of Veterinary Services (DVS), MOA

9 VETERINARY PRODUCT REGISTRATION DVS Biologic DVS Vaccine NPRA Veterinary Drug

10 CRITERIA FOR REGISTRATION OF VETERINARY BIOLOGICS BIOLOGICS Veterinary Biologics Submission of 2 copies of dossier together with TACB 9 Form. Please refer to a) General information( eg : Name of biologic/ test kit (Trade / Generic Name) b) Technical Information/Data on Biologic/ Test kit production : c) Description of the products (eg:efficacy claim, target species) a) Clinical particulars (eg: indication use,precautions for use,contra-indications) b) Product particulars (eg: pack sizes, shelf life) c) Other Information and Supporting Documents (eg: COA) Registration application by sole local agent company & be authorized in writing by manufacturer to be the holder of registration Validity period of registration: 5 years Renewal: Done not later than 3 months prior to expiry date Application type a) Vaccines b) Other biologics (i.e. enzymes, hormones, probiotics, feed additive,plasma etc.)/test kit Registration of vaccine is subject to prior approval of manufacturer and local importer/distributor. Registration of other biologics must be accompanied with copy of Establishment license

11 BIOLOGIC REGISTRATION PROCEDURE 2 set of dossiers with data on; i) efficacy ii) safety and iii) other supporting documents TACB 9 form: submit together with the dossier Each certificate requested; i) must be valid at the time of the application ii) shall be accompanied by a valid English translation. DVS will issue a letterstatus of application. Approved product- Veterinary Biologic Reg. Cert. Validity period of registration : 5 years Importation; - Apply license (for feed/ premix) - Apply import permit (MAQIS) - Veterinary Health Cert.

12 VACCINE REGISTRATION PROCEDURE TACB 6 FORM 1x only LOCAL AGENT MANUFACTURER TACB 7 FORM 1x only TACB 1 FORM TACB 2 FORM Each type of vaccine VACCINES

13 VACCINE PLANT REGISTRATION Application (2 sets dossiers) Evaluation Additional information (if required) Plant Visit / Inspection TACB meeting decide to approve / reject

14 DOSSIER SUBMISSION (VETERINARY VACCINES) Part I Part II Part III General Information Supporting documents (i.e. COO, COA, Reg. Cert) Vaccination Regime Part IV Packaging Information Part V Technical Information A. Starting Material B. Finished Product

15 FEES APPLICATION RM 200 TECHNICAL EVALUATION RM 800 APPROVAL RM 500 RENEWAL (5 YEARS) RM 350

16 IMPORTATION OF VETERINARY BIOLOGICS FOR RESEARCH USE Application to import veterinary biologics for research purpose may not be subjected to registration procedures but shall include the following details for DVS evaluation prior to importation; Covering letter from the researcher/ institution explaining briefly and clearly the purpose of importing the product and the name of the farms/ clinics/ institutions/ company where the product will be used. A brief description of research work may be attached if necessary. Brief description of the product including species of animals of origin or cell cultures involved Certificate of analysis (COA) with details on methods of sterilization/inactivation (if any) and/or purification of the products Copy of the purchase order (PO) from the Government, Universities or Research Institutes Applicant must apply for an import permit from MAQIS

17 DEREGISTRATION OF DEREGISTRATION OF BIOLOGIC/ TEST KIT BIOLOGIC/ TEST KIT Biologic and Veterinary Drug Control Unit may from time to time advice the Director General on the need for deregistration of any animal biologic/ diagnostic test kit; In the event that there is non-compliance of the biologic to safety, potency, efficacy and purity standards or Adverse reactions or health hazard to human or animals.

18 DEREGISTRATION OF PENALTIES BIOLOGIC/ TEST KIT In the event that the company has brought in unregistered biologic/ diagnostic test kit, the registration of the company will be cancelled. Failure to inform DVS of any serious contamination of the product by the importer may result in the cancellation of the registration of the importer.

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20 TOTAL OF APPLICATION REGISTERED VS APPROVED VETERINARY VACCINE

21 CURRENT STATUS -VACCINE Total of 449 approved Veterinary Vaccines until 2016 (by species) Avian 343 Porcine 57 Canine 23 Feline 13 Bovine 4 Ovine/ Caprine 1 Equine 6 Aquatic 2

22 BIOLOGICS APPLICATION REGISTRERED YEAR APPLICATION REGISTERED

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