MAPA Publishes Draft Regulation on the Registration of Generic and Interchangeable Similar Veterinary Medicines – Public Consultation

The Ministry of Agriculture and Livestock (“MAPA”) has submitted a draft Ordinance for public consultation regarding the technical regulation for the registration of generic and interchangeable similar veterinary medicines. The public consultation will remain open for 45 days for contributions from the sector, with the period beginning on April 15.

As this is a proposed regulation intended to establish the rules for registering generic and interchangeable similar veterinary medicines, its content is quite detailed and sets out how this administrative procedure will operate, in addition to addressing several highly relevant matters, summarized below.

There are important points that should be considered by the sector, such as rules concerning the public procurement of these products, as well as other provisions that may significantly impact competition among companies for the same medicine.

The regulation establishes measures to be taken before filing a registration application, with three steps to be completed: (i) requesting the designation of the reference medicine, which is essential for all comparability studies; (ii) notifying MAPA of the manufacture of the pilot batch; and (iii) submitting a schedule for the bioequivalence studies, including the dates of each stage and the locations where they will be conducted.

The regulation establishes strict deadlines for complying with these obligations: the study schedule must be submitted to MAPA at least 45 days in advance, and any changes must be communicated at least 20 days in advance, allowing MAPA to conduct on-site monitoring, if necessary.

In summary, the mandatory documents for the registration process are: technical report; pilot-batch data; specifications for the active pharmaceutical ingredient (API); stability studies; pharmaceutical equivalence; bioequivalence studies, when required; residue studies, when applicable; package leaflet for the reference medicine; labeling and packaging materials; and a declaration from the responsible technical professional (“RT”).

With regard to the technical criteria for equivalence, the regulation requires the studies to be conducted simultaneously, using both the test and reference medicines; validated methods evaluated by the laboratory conducting the studies; among other criteria. There are also specific labeling rules for generic medicines, including the use of DCB/INN nomenclature, a yellow band, and warnings identical to those of the reference medicine. For interchangeable similar medicines, the rules require identification by trade name, inclusion of the claim “interchangeable similar,” and warnings identical to those of the reference medicine.

There are also rules concerning pricing and dispensing: prescriptions and public procurement procedures must use DCB/INN nomenclature; generic medicines will have preference in public procurement; and substitution rules will vary depending on the form in which the medicine is prescribed.

With respect to reference medicines, the draft Ordinance establishes criteria for their designation, including active registration, proven efficacy and safety, and expiration of applicable protection periods. It also provides rules for exclusion and for situations involving unavailability, including the possibility of designating a substitute reference medicine.

Finally, the draft Ordinance requires studies to be conducted in laboratories accredited by the National Institute of Metrology, Quality and Technology, of the Ministry of Development, Industry, Foreign Trade and Services (“INMETRO”), provided that such laboratories do not belong to the same economic group as the holder of the registration application and have no direct involvement in the importation, manufacture, or commercialization of veterinary products, nor in representation or activities that could constitute a conflict of interest.

There is also a transition period: for up to three years following publication of the forthcoming regulation, comparability studies conducted in laboratories not accredited by INMETRO may be accepted, provided that they were performed in laboratories with metrological recognition for the corresponding scope and that all other requirements have been met.

When MAPA is unable to designate a reference medicine to be used in a comparability study, registration will be subject to the ordinary procedure established under specific legislation.

Another relevant point addressed in the draft Ordinance concerns incremental innovations: incremental innovations made to the reference medicine may only be incorporated into generic or interchangeable similar medicines registered on the basis of that reference medicine after expiration of the data protection period established under Law No. 10,603/2002.

This material is for informational purposes only and should not be used independently as a basis for decision-making. Specific legal advice may be provided by one of our attorneys. All copyrights are reserved by KESTENER VIEIRA TORRONTEGUY SPEGIORIN ADVOGADOS.