Veterinary Medicine
FAQ Vet - general
- General/Regulatory
- Classification
- Change Of Product Registration Holder(COH)
- Change Of Site (COS)
- Variation
- Renewal
GENERAL/REGULATORY
1.What are the types of veterinary products that are regulated by NPRA?
Paragraph 7(1)(a) of the Control of Drugs and Cosmetics Regulations 1984 requires all products to be registered with the DCA prior to being manufactured, sold, supplied, imported, possessed or administered, unless the product is exempted under the specific provisions of the Regulations.
A ‘product’ as defined in the Regulations means
- a drug in a dosage unit or otherwise, for use wholly or mainly by being administered to one or more human beings or animals for a medicinal purpose; or
- a drug to be used as an ingredient of a preparation for a medicinal purpose
Please refer to Appendix 14 Regulation of Veterinary Product in Malaysia, REGOVP.
2. If a product has been approved by other regulatory agencies such as the FDA, or has worldwide registration status , does it have to be registered with DCA again?
For all products to be marketed in Malaysia, they must be registered with DCA even though they have been registered in other countries.
3. Can a product be imported into this country and be exported again without being registered?
4.How do I search for a registered veterinary product on NPRA website?
User can search the registered veterinary product through NPRA website. Please click Home → Product search
5. Do premixes need to be registered?
6. Are veterinary products for aquaculture use come under the purview of this regulation?
Yes, if these products intended to be administered for medicinal purpose.
7. Are dietary/health supplements and herbal/natural products for veterinary use come under the purview of this regulation?
Yes, if the dietary/ health supplements and herbal/ natural products contain therapeutic claims/ indications. They are considered as Non-Poison (OTC) product. Scientific evidence and efficacy data will be required for the registration of any therapeutic claim.
8. What is the category of my product if it is an old innovator product?
The product is still classified as Innovator product even it exists in the markets for years because it is categorized as an innovator product in the country of origin.
9. Can the registration be done manually?
No. All applications for registration must be done online via Quest system .
10. Where can I find the application form for registration of veterinary product?
11. What are the requirements for registration of veterinary product?
The data required to support an application is divided into :
- Administrative documentation (Part I)
- Quality documentation (Part II)
- Safety and residues documentation (Part III) ; and
- Efficacy documentation (Part IV)
Please refer to NPRA official website www.npra.gov.my , Click Industry → Veterinary Medicines → Guidelines → Registration guideline of Veterinary products (REGOVP). The REGOVP provides detailed information on the registration of veterinary products.
12. What if I can’t provide latest data for Part III and Part IV as the product is an old innovator product?
NPRA will accept valid and old data for Part III and Part IV. If the data cannot fulfill the latest requirements, justification letter is required to be submitted.
13. What are the specific requirements for product used in food producing animals?
A specific withdrawal period and MRL need to be stated according to the target species.
14. What is a Maximum Residue Limit (MRL)?
A Maximum Residual Limit (MRL) is defined as the maximum concentration of residue resulting from the use of a veterinary medicinal product (expressed in mg/kg or g/kg on a fresh weight basis) which may be accepted to be legally permitted or recognised as acceptable in or on a food.
15. What information is required on the label of a veterinary drug?
Please refer to Appendix 5, Label (Mock-up) for Immediate Container and Outer Carton, REGOVP.
16. Can foreign languages be used on the labels of the products? For registered products to be exported to other countries, are we allowed to change the labels in order to comply with the requirements of the importing country?
Yes, provided there is also Bahasa Malaysia or English version on the labels.
For export products the labels can be changed based on the requirements of the importing countries.
17. For an imported product, can the registration number be pasted on the product package?
No. The registration number has to be imprinted on the labels.
18. What happens if the issuing body of the GMP/CFS/CPP certificates of my product is not listed in the Quest System?
A request for the listing of the issuing body shall be done through the Quest system (not listed).
19.Are CPPs mandatory for all imported products?
20. Can I apply Certificate of Free Sale (CFS) for “For Export Only” product?
No, NPRA will not issue CFS for “For Export Only” product since the product is not freely sold in Malaysia.
21. Some manufacturers do not have stability data. Does NPRA accept applications without stability data?
For more information on stability data, you may refer to Appendix 9 -Guideline For Stability Data, REGOVP
22. Is Zone IVB stability requirements imposed on veterinary product?
No. Zone IVB stability requirements are not imposed on veterinary product. The requirements for stability data are stated in Guideline for Stability Data, Registration Guideline of Veterinary Products (REGOVP).
23. Will NPRA accept stability data conducted at storage condition 30°C ± 2°C /65% RH ±5% RH?
Yes, NPRA will accept the stability data with the condition humidity condition reflected on the label.
24. As a manufacturer, if I do not have my own lab facility to carry out the tests on my products, can I contract out the tests to an external lab?
Yes, you can.