Brazil and Costa Rica Regulate Drug Registration: Brazilian Executive Extends Consultation on Intellectual Property
9 septiembre 2020

BRAZIL AND COSTA RICA

On August 27, the Brazilian National Health Surveillance Agency (Anvisa, in Spanish), issued Resolution No. 415 defining new criteria and extraordinary procedures regarding requests to register medicines and biological products in the framework of the pandemic. In addition, the Executive extended the deadline for participation in the public consultation on the National Intellectual Property Strategy for 14 days. Those interested in participating may do so until September 13. Meanwhile, the Costa Rican Ministry of Health extended the validity of drug registrations until June 2021.

Through the Resolution, Anvisa defined the criteria to be followed for registration requests and subsequent changes to drug registration. The products covered must be considered essential for the maintenance of life or intended for use in the event of a serious risk to health. Also included are those whose availability is threatened by the risk of shortages on the market due to reasons directly related to the coronavirus.

In addition, the agency, through Normative Instruction No. 65 regulated certain aspects of classification and registration for biological products. Also issued were Resolution No. 412 on stability studies for biological products and Resolution No. 413 specifically regulating the registration modifications of the products.

On the other hand, the Executive extended the consultation period on the National Intellectual Property Strategy (see here). While  the original plan  was for the consultation period for the proposal covering drug patents to be open until August 30, this period has now been extended until September 13. Those interested may send their comments through the electronic forms available on the Ministry of Economy’s Webpage.

In other news, the Decree issued by the Costa Rican Ministry of Health establishes that records due to expire between September and December 2020 will now be valid until the period between March and June 2021.

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