“It is expected that the proposal presented will bring greater rationalization of processes, with no major impacts on the operations of animal health industries.”
Marcos Vinícius de Santana Leandro Júnior is the general coordinator of products for veterinary use in the Department of Animal Health, of the Ministry of Agriculture.
Leandro Júnior has a degree in veterinary medicine from the Federal University of Lavras and a master’s degree in experimental physiopathology from the University of São Paulo.
AgriBrasilis – How long does it take to register pharmaceutical and biological veterinary products? Is there a priority for analysis according to the type of product?
Leandro Júnior – The requests for registration of products for veterinary use, whether biological or pharmaceutical, are distributed for analysis within 45 days after protocol through Ministry of Agriculture’s system.
Ministry of Agriculture published SDA Ordinance 72, with the priority criteria for requesting analysis, being the criteria based on product innovation, and not on therapeutic categories.
AgriBrasilis – What is the generic product registration based on and how does it differ from a new active ingredient registration?
Leandro Júnior – The registration of a generic veterinary product is based on the composition with the same active ingredients of the reference veterinary drug, with the same concentration, pharmaceutical form, route of administration, dosage and therapeutic indication, allowing differences only in characteristics relating to size, shape, shelf life, packaging, labeling, excipients and product vehicles.
Registration of a generic product requires proof of bioequivalence, efficacy, and safety through pharmaceutical studies.
AgriBrasilis – What types of products are exempt from registration by the Ministry of Agriculture? What guarantees the quality of these products?
Leandro Júnior – The Ministry of Agriculture currently exempts from registration the following categories:
- Product of veterinary use that is imported, intended exclusively to the official or private entity for the purpose of research and scientific experimentation, under the control of a veterinarian; or for the purpose of official sanitary programs.
- Products for veterinary use without therapeutic action, intended exclusively for the hygiene and beautification of animals.
- Pharmaceutical product and biological product semi-finished (in bulk) that are imported, when intended for the manufacture of a product already registered.
- Product imported by individuals, not submitted to special control regime, in quantity for individual use and not intended for commercialization.
- Biological material, infectious agent and seed, destined for experimentation or manufacture of products.
- Product to be applied on surfaces such as carpet, curtain, wall, furniture, cushion and similars, destined exclusively to keep animals away from the place where it was applied.
- Homeopathic product for veterinary use.
- Product for veterinary use prepared by manipulation in registered establishments.
- Autogenous vaccines.
- Commodities intended exclusively for commercialization to manufacturers of products for veterinary use registered with the Ministry of Agriculture.
The fact that the product is exempt from registration does not mean that it also is exempt from following the regulations in force in Brazil, including those of quality and safety. The evaluation and quality assurance are the responsibility of the manufacturer of the product, and the Ministry of Agriculture is responsible for supervising the sector.
AgriBrasilis – In which cases is the participation of agencies other than the Ministry of Agriculture necessary, such as CTNBio or Anvisa, in the registration process?
Leandro Júnior – The registration and inspection of products for veterinary use are the responsibility of the Ministry of Agriculture, with no direct interference of other agencies in the process.
To perform the registration and inspection activities of products that contain Genetically Modified Organisms, the Ministry of Agriculture requires the presentation of certificates issued by CTNBio, which is the agency that regulates the subject.
For the registration of products for veterinary use intended for use in food-producing animals, the Ministry of Agriculture relies on the regulations published by Anvisa.
The Ministry of Agriculture also articulates with health agencies regarding the efficacy parameters of products for veterinary use that are used in health campaigns of these agencies.
AgriBrasilis – Why is it necessary to modify Decree No. 5.053/2004, which addresses the Regulation for Registration of Veterinary Products? What are the main proposed changes and for what reasons?
Leandro Júnior – The proposal for updating the regulation was published for discussion with society about the incorporation of concepts that are not contemplated today, such as the registration of products for veterinary use in phases, the expansion of the Responsible Technicians’ responsibility in the companies and products, the administration of off label products, the supervision of the use of products, the regulation of establishments that conduct clinical studies, among others.
The proposed text seeks to initiate a debate with society, aiming to publish a regulation that allows debureaucratizing processes, improving analysis times and Ministry of Agriculture’s timely response to inspection and registration demands of products for veterinary use.
It is expected that the proposal presented will bring greater rationalization of processes, with no major impacts on the operations of animal health industries.
AgriBrasilis – Are there any plans to mitigate the problem of the shortage of Contract Research Organizations, known as CROs? What are the reasons for this shortage?
Leandro Júnior – The proposal under discussion includes establishments that conduct clinical research in the list of those that are part of the inspection procedures of the Ministry of Agriculture. With this inclusion, the Ministry will now make available guides, procedures, and guidelines for the operation of these establishments. In this way, the Ministry believes that entrepreneurs who are interested in investing in this type of facility will have more predictability of investments and operating costs, increasing the number of available establishments.