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 12 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?
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?
5. Do premixes need to be registered?
6. Are veterinary products for aquaculture use come under the purview of this regulation?
7. Are dietary/health supplements and herbal/natural products for veterinary use come under the purview of this regulation?
8. What is the category of my product if it is an old innovator product?
9. Can the registration be done manually?
10. Where can I find the application form for registration of veterinary product?
11. What are the requirements for registration of veterinary product?
12. What if I can’t provide latest data for Part III and Part IV as the product is an old innovator product?
13. What are the specific requirements for product used in food producing animals?
14. What is a Maximum Residue Limit (MRL)?
15. What information is required on the label of a veterinary drug?
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?
17. For an imported product, can the registration number be pasted on the product package?
18. What happens if the issuing body of the GMP/CFS/CPP certificates of my product is not listed in the Quest System?
19.Are CPPs mandatory for all imported products?
20. Can I apply Certificate of Free Sale (CFS) for “For Export Only” product?
21. Some manufacturers do not have stability data. Does NPRA accept applications without stability data?
22. Is Zone IVB stability requirements imposed on veterinary product?
23. Will NPRA accept stability data conducted at storage condition 30°C ± 2°C /65% RH ±5% RH?
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?
25. Can I make an appeal if my product application is rejected by the Drug Control Authority (DCA)?

National Pharmaceutical Regulatory Agency (NPRA)
Lot 36, Jalan Universiti, 46200 Petaling Jaya, Selangor, Malaysia.
  • Email: npra@npra.gov.my
  • Phone: +603-7883 5400
  • Fax: +603-7956 2924, +603-7956 7075

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