How to Regularize Veterinary Vaccines?

Before starting the regularization process, it is essential to understand the specific regulations governing the production and commercialization of veterinary vaccines in the country. In Brazil, the Ministry of Agriculture, Livestock, and Supply (MAPA) is responsible for regulating and inspecting these products, through the General Coordination of Agrochemicals and Related Products (CGAA) and the Coordination of Veterinary Products (CPV).

The next step is the preparation of the technical dossier, which includes detailed information about the vaccine, such as its composition, production method, safety and efficacy studies, among others. This dossier must comply with the standards established by MAPA and be submitted for evaluation.

Before being registered, veterinary vaccines usually undergo pre-clinical and clinical trials to assess their safety and efficacy in animals. These studies are conducted according to international standards and must be carried out by accredited laboratories.

With the complete technical dossier and trials conducted, the next step is to request the registration of the vaccine with MAPA. This process involves filling out specific forms, paying fees, and presenting all necessary documentation.

After submitting the registration request, MAPA will conduct a detailed evaluation of the technical dossier and may inspect the vaccine production site to verify compliance with good manufacturing practices and other regulatory requirements.

If all requirements are met and the vaccine is deemed safe and effective, MAPA will issue the product registration, allowing its commercialization in the Brazilian veterinary market.

The regularization of veterinary vaccines is a complex process, but essential to ensure the quality and safety of these products. By following the steps and requirements established by MAPA, manufacturers of veterinary vaccines contribute to the protection of animal health and the development of the veterinary products sector in Brazil.

Stone Okamont provides specialized support to companies in registering veterinary vaccines with MAPA, offering consultancy, documentation preparation, assistance in the registration process, and regulatory updates. They assist clients at every step, ensuring compliance with regulations.

Through a highly qualified team, Stone Okamont offers specialized consultancy, guiding clients through the complex regulatory requirements set by MAPA. Additionally, they assist in the thorough preparation of the necessary documentation for registration, ensuring that all forms are correctly filled out and the documents comply with current regulations.