VETERINARY PRODUCT REGISTRATION -...
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Biologics & Veterinary Drug Control Unit Department of Veterinary Services, Malaysia VETERINARY PRODUCT REGISTRATION
Transcript of VETERINARY PRODUCT REGISTRATION -...
Biologics & Veterinary Drug Control Unit
Department of Veterinary Services, Malaysia
VETERINARY PRODUCT REGISTRATION
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
DEFINITION OF VETERINARY BIOLOGICS
• Any viruses, serums, toxins, antitoxins,
vaccines, live microorganisms, killed micro-
organisms, 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
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
LEGISLATION
•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
VETERINARY BIOLOGICSBlood 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)
VETERINARY PRODUCT REGISTRATION
DVS
Biologics
NPRA
Scheduled Poison
Non poison/
OTC
DOA
Pesticide
Department of
Veterinary Service
National
Pharmaceutical
Regulatory Agency
Department of
Agriculture
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)
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 National
Pharmaceutical Regulatory
Agency (NPRA), MOH
Regulated under Department
of Veterinary Services (DVS),
MOA
VETERINARY PRODUCT REGISTRATION
DVS
DVS
NPRA
Biologic
Vaccine
Veterinary
Drug
CRITERIA FOR REGISTRATION OF VETERINARY BIOLOGICS
BIOLOGICS
Veterinary Biologics – Submission of 2 copies of dossier together with TACB 9 Form. Please
refer to www.dvs.gov.my
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
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 letter-status of application. Approved product-Veterinary Biologic Reg. Cert.
Importation;
- Apply license (for feed/ premix)
- Apply import permit
(MAQIS)
- Veterinary Health Cert.
www.dvs.gov.my Validity period of registration : 5 years
VACCINE REGISTRATION PROCEDURE
• TACB 6 FORM
• 1x only
LOCAL AGENT
• TACB 7 FORM
• 1x only
MANUFACTURER • TACB 1 FORM
• TACB 2 FORM
• Each type of vaccine
VACCINES
www.dvs.gov.my
3
3
32
1
VACCINE PLANT REGISTRATION
Application (2 sets dossiers)
Evaluation
Additional information (if required)
Plant Visit / Inspection
TACB meeting – decide to approve / reject
DOSSIER SUBMISSION(VETERINARY VACCINES)
Part I General Information
Part IISupporting documents
(i.e. COO, COA, Reg. Cert)
Part III Vaccination Regime
Part IV Packaging Information
Part VTechnical
Information
A. Starting
Material
B. Finished
Product
FEES
APPLICATION
RM 200
TECHNICAL EVALUATION
RM 800
APPROVAL
RM 500
RENEWAL
(5 YEARS)
RM 350
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
DEREGISTRATION OF BIOLOGIC/ TEST KIT
DEREGISTRATION OF 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.
DEREGISTRATION OF BIOLOGIC/ TEST KIT
PENALTIES
• 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.
TOTAL OF APPLICATION REGISTERED VS
APPROVED VETERINARY VACCINE
CURRENT STATUS -VACCINE
Avian
343 Porcine
57
Canine
23
Feline
13
Bovine
4
Ovine/ Caprine
1
Equine
6
Aquatic
2
Total of 449 approved Veterinary
Vaccines until 2016 (by species)
BIOLOGICS APPLICATION REGISTRERED 2013- 2016
YEAR APPLICATION REGISTERED
2013 365
2014 652
2015 476
2016 524
