Frequently Asked Questions (FAQs) Veterinary Medicine
CLASSIFICATION
The Registration Guideline of Veterinary Products (REGOVP) lays the information on the regulation of the veterinary medicinal product regulated by the DCA.
Section A of the guideline describes the types and criteria of the veterinary medicinal products under the purview of the DCA. Applications for veterinary medicinal product classification may be submitted for further clarification on the veterinary medicinal product category.
Applicants may apply for veterinary medicinal product classification by completing the Product Classification Application NPRA 300.1 form and submitting it to NPRA for the classification/ categorization process.
For veterinary medicinal product classification application, the complete Product Classification Application NPRA 300.1 form shall be submitted to NPRA. The form can be downloaded from the Application Form page in the Veterinary section under the Industry page in the website www.npra.gov.my.
Applicants shall submit a product classification application by sending a completed form (instructions as stated on the front page of the form) together with the processing fee to Finance Unit, NPRA.
The processing of the veterinary medicinal product classification application will ensue once the product classification application form is deemed complete and the payment made is confirmed.
Only one (1) veterinary medicinal product is allowed per Product Classification Application NPRA 300.1 form. Applicants shall submit more than one (1) product classification application form if the veterinary medicinal product to be classified is more than one (1).
A fee of RM300 per veterinary medicinal product classification application is imposed for the processing of the veterinary medicinal product classification application.
A time frame of 14 working days is appointed for the processing of the veterinary medicinal product classification application.
A veterinary medicinal product registration application may be submitted if the product is intended to be authorized and marketed in Malaysia. The veterinary medicinal product category in the product registration application shall be selected in accordance with the veterinary medicinal product classification outcome received.
The veterinary medicinal product registration application requires an online submission and it can be accessed via the Quest3+ System Log In page from the website www.npra.gov.my.
Further information on the veterinary medicinal product registration requirements and procedures can be referred to the Registration Guideline of Veterinary Products (REGOVP) and relevant sections from the website www.npra.gov.my.
