The regulatory entity seeks to increase solutions to the registration of generic or similar medications when the benchmark medication is out of stock in the Brazilian market. Interested companies and individuals will have until November 1st to make contributions to the bill.
The National Health Surveillance Agency (Agencia Nacional de Vigilancia Sanitaria or Anvisa) opened one of the entity’s decisions for public inquiry. The bill amends Resolution Nº 35, dated June 15, 2012, which establishes the steps to follow for an interested company to register or renew a license for a generic or similar medication to perform bioequivalence testing with a benchmark medication.
It should be noted that this procedure is exclusive to medications manufactured for hospitals and other health service establishments or to supply government programs.
The aforementioned legislation provides that if there is a shortage of this benchmark medication, the Anvisa can authorize its purchase abroad as long as the regulations established by this institution are followed.
Meanwhile, the proposed reform seeks to expand the possibilities of purchasing these benchmark medications using two approaches: one consists of asking the Anvisa to prioritize post-registration modifications to the benchmark medication if justified by the lack of stock within the market; and the other establishes the possibility of substituting the medication on the List of Benchmark Medications following a year of its absence in the national market.
The Anvisa will open a public inquiry until November 1st wherein interested parties and institutions can make their contributions before the proposal is analyzed by the institution’s Collegiate Leadership.