Following the amendment made to the National Health Technology Assessment System (SiNATS) by the Decree-Law No. 115/2017, on the 24th October 2017 the Deliberation No. 80/CD/2017 which approves the new version of the Regulation for the Program of Early Access to Medicines (EAP) was published.
This Regulation defines the new authorization terms and procedures for the EAP’s, namely:
- Timelines for approval of EAPs by INFARMED;
- Validity period of the authorization of the EAPs;
- Communication to SPMS – “Serviços Partilhados do Ministério da Saúde, E.P.E”;
- Duty of transparency by INFARMED.
This Deliberation comes into force on November 6, 2017 and replaces the Deliberation No. 139/CD/2014.