Veterinary Product Registration in Malaysia
Introduction
Ensuring Compliance with NPRA & DVS
Bringing veterinary products into the Malaysian market requires compliance with regulatory frameworks set by two key agencies: the National Pharmaceutical Regulatory Agency (NPRA) and the Department of Veterinary Services (DVS). These regulatory bodies ensure that veterinary medicines, feed additives, and related products are safe, effective, and meet all legal requirements before they are marketed and distributed.
At Victory Pharma Consultancy, we provide end-to-end regulatory support for veterinary product registration, handling all documentation and submission processes to help businesses navigate Malaysia’s stringent requirements with ease.
Understanding Veterinary Product Registration in Malaysia
NPRA (National Pharmaceutical Regulatory Agency)
NPRA regulates veterinary pharmaceuticals, biologics, and medicated feed additives under the Control of Drugs and Cosmetics Regulations 1984. Registration is done via the QUEST3+ system, ensuring that veterinary products meet stringent safety, efficacy, and quality standards.
Key NPRA Requirements:
- Product Classification: Determining if the product is a veterinary drug, biological product, or supplement.
- Good Manufacturing Practice (GMP) compliance: Mandatory for manufacturers.
- Stability and Safety Data: Ensuring the product meets local climate and regulatory conditions.
- Dossier Preparation: Compiling required documentation for submission.
DVS (Department of Veterinary Services)
DVS oversees the registration and importation of non-pharmaceutical veterinary products, including feed additives, vaccines, animal health supplements, and pet food. Approval from DVS is essential for compliance under the Animal Feed Act 2009 and the Veterinary Surgeons Act 1974.
Key DVS Requirements:
- Import Permit Application: Required for foreign veterinary products.
- DVS Product Evaluation: Ensuring compliance with Malaysia’s veterinary health standards.
- Labelling and Packaging Compliance: Aligning with regulatory guidelines for proper product identification.
Who Needs to Register Their Veterinary Products?
- Veterinary pharmaceutical manufacturers
- Importers and distributors of animal health products
- Companies supplying medicated feed additives
- Producers of veterinary vaccines and biologics
If you are a foreign company, you are required to appoint a local authorized agent to manage the registration process in compliance with NPRA and DVS regulations. Victory Pharma Consultancy acts as your trusted regulatory partner to facilitate seamless approval and market entry.
Registration Process Overview
Why Choose Victory Pharma Consultancy
- Expertise in NPRA & DVS regulations
- Hassle-free document preparation and submission
- 100% track record in obtaining approvals
- Trusted local representative for foreign brands
- End-to-end regulatory support
Our team is highly experienced in navigating bureaucratic complexities and ensuring that your veterinary products are approved quickly and efficiently.