MAPA inspector clarifies about product registration steps
Brazil is the largest exporter of animal protein in the world, where its herd is estimated in 237 million heads of cattle, spread over 162.3 million hectares intended only for livestock, and corresponding to approximately 19% of the entire Brazilian territory. Poultry farming, in 2019, produced 13.9 million tons of chicken and pork production reaches 3.9 million tons per year.
The animal health inputs are proportional to the animal production, with revenues of approximately US$ 1.3 billion in 2019. Among the therapeutic classes, a highlight for biological animal health products that
correspond to more than 20% of the market, while antiparasitic products, have represented almost 30%.
AgriBrasilis interviewed the veterinarian José Ricardo Lôbo, responsible for the General Coordination of
Veterinary Products of the Brazilian Ministry of Agriculture, Livestock and Supply (MAPA). José Ricardo Lôbo gave an overview about animal health product registration process and addressed future perspectives on new updates in this process.
AgriBrasilis – How are veterinary products classified for MAPA registration purposes?
José Ricardo Lôbo – Animal health products are all chemical, biological, biotechnological substances or manufactured preparation which administration whether applied individually or collectively, direct or mixed with food, for the prevention, diagnosis, cure or treatment of animal diseases, including additives, promoter supplies, animal production improvers, medicines, vaccines, antiseptics, disinfectants
for environmental use or equipment, pesticides and all products that, used in animals or in their habitat,
protect, restore or modify their organic functions and physiological, as well as products intended for the
beautification of animals.
As a rule, these products are classified into pharmaceuticals and biologicals. A product classification proposal is being evaluated based on risk / impact, with differentiated requirements depending on that risk.
AgriBrasilis – What tests are required for registration of these products?
José Ricardo Lôbo – The registration applicant needs to perform tests of efficacy, safety and stability. In the case of food-producing animals, safety studies include residue studies and product safety interval.
AgriBrasilis – Besides MAPA, that is in charge of registration, are there other ministries involved in animal health product registration?
José Ricardo Lôbo – MAPA is the only agency in charge of animal health product registrations. In some situations, it is possible that MAPA seeks for assistance to CTNBio (National Technical Commission on Biosafety), ANVISA or environmental agencies’. ANVISA is responsible for establishing the maximum limits of residues of animal health products for veterinary use, when related to species for human consumption.
AgriBrasilis – How long does it take for registration approval in recent months?
José Ricardo Lôbo – In the case of animal health pharmaceutical products, the average is four to five
years until the conclusion of the analysis. In the case of biological products, the average term is one and a half to two years. It is worth mentioning that the long term for evaluation is being substantially reduced. Since April 2019, MAPA has taken from three to fourteen the number of Federal Agricultural Inspectors analysts for registration process evaluation.
Adding the expectation of improving the quality of dossiers submitted by the regulated sector, this due to
the leveling carried out in 2016, as well as the entry into force of the new tacit approval rule, which for
these products establishes a maximum of 720 days. There is also the possibility of priority analysis, supported by Ordinance 72, of June 2nd, 2017, granting a license in less than one year
AgriBrasilis – Is there any change in legislation regarding product registration under discussion?
José Ricardo Lôbo – A discussion will begin to update Decree 5053, of April 22nd, 2004. In addition, a Normative Instruction is being elaborated for the classification of animal health products based on their risk and impact, and correlated with prioritizing the analysis to approve a registration. Other smaller rules are also under review, three of them in public consultation. Videlicet:
– Normative Instruction Project that aims to update the Technical Regulation for Requirements and
Procedures, evaluation of the efficacy, safety and labeling of antiparasitic products for veterinary use, produced in the country or imported, for registration, change of registration and renewal of registration – Ordinance No. 86, of April 8th, 2020;
– Normative Instruction of Technical Regulation Project, containing requirements for simplified animal
health veterinary product registration – Ordinance No. 71, of April 8th, 2020;
– Normative Ruling Project that changes the text of Normative Ruling No. 26, of September 7th, 2009,
which approves TECHNICAL REGULATION FOR MANUFACTURING, QUALITY CONTROL, MARKETING AND EMPLOYMENT OF ANTIMICROBIAL PRODUCTS FOR VETERINARY USE – Ordinance No. 70, of April 8th, 2020.
AgriBrasilis – What difficulties do you consider most prevalent in the product registration process?
José Ricardo Lôbo – Until the beginning of 2019, certainly the lack of personnel to analyze the registration processes was the greatest difficulty. Currently the complexity of the analysis, since there are several studies that require high technical knowledge and knowledge of the legislation, besides the constant improvement of technicians.
AgriBrasilis – After the registration is approved, are there any other legal requirement to sell the products?
José Ricardo Lôbo – After registration approval, sales are immediately allowed. A pharmacovigilance normative is in progress; products will continue to be released for sale after registration is approved, but MAPA will monitor the adverse effects that may be caused by these products. Today it is carried out by the companies (registration holders), but without MAPA guidelines.