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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