Law authorizes prescription of medicine in SUS with indication different from that provided by Anvisa – Notícias

03/22/2022 – 10:24


The efficacy and safety of the drug for the new use must be proven

This Tuesday (22) Law 14,313/22 came into force, which authorizes the prescription in the Unified Health System (SUS) of medicines and products with an indication of use different from that approved by the National Health Surveillance Agency (Anvisa) if that is the case. is recommended by the National Commission for the Incorporation of Technologies in the SUS (Conitec).

Conitec is an advisory body of the Ministry of Health that evaluates drugs and clinical protocols used in the SUS.

The new law was published this Tuesday in the Official Gazette. The rule comes from a proposal (PL 1613/21) by former senator Cássio Cunha Lima (PB). there was not vetoes to the text approved by the Chamber of Deputies and the Senate.

According to the law, scientific evidence on the effectiveness and safety of the drug for the new use must be demonstrated, with standardization in a protocol established by the Ministry of Health.

The use of medication or product recommended by the commission and purchased through international multilateral organizations, such as the Pan American Health Organization (PAHO), for use in the ministry’s public health programs is also allowed.

Reporting – Janary Junior
Editing – Marcia Becker

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