Brazil: The ANVISA open public consultation on the convenience only authorize import of drugs, without registering



The national sanitary vigilance agency (ANVISA) has published, in theOfficial journal of the european (D.O.U) of the past 28 januarythePublic Consultation 775/2020with the aim of collecting information before making the change of theResolution RDC 203/2017, which establishes criteria and procedures for the import - exceptionally - circumstances of the product subject to a health check, which are not registered in the agency. The objective of the consultation is to collect critical assessments and informed of the parties concerned on the draft resolution at the debate.

The consultation will be open for 15 days, starting the account seven days after its publication in the D.O.U., so that interested parties to participate in consultation with written comments until 18 february 2020, through the following link: id _ aplicacao = 53445

The adoption of this proposal, would extend the scope of the previous resolution, including, in addition to the inmunobiologicos, insecticides, medicines and other strategic inputs acquired through multilateral organizations, for use in public health programmes of the ministry of health and related entities.

If the proposal was adopted, the statement that it gives a scenario of scarcity, which is one of the criteria for import goods without registration, passed to the ministry of health, and it would also be of this ministry who had the responsibility to ensure the quality of products, instead of ANVISA, as is currently.