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Gene Therapy Legislation in Portugal

Permits for clinical trials are to be applied for at Infarmed the National Institute of Pharmacy and Medicines. The beginning of a clinical trial in Portugal is dependent on authorisation from Infarmed and a favourable opinion of the National Ethics Committee for Clinical Research (CEIC). Data related to the evaluation of clinical trials by CEIC are available at CEIC's webpage. If gene therapy trial includes a GMO, the AgĂȘncia Portuguesa do Ambiente (APA) of the Ministry of Environment in Portugal is the competent authority for GMO deliberate release or contained use authorisations. Positive opinion by APA is required for the clinical trial authorisation by Infarmed.
No specific guidelines available for clinical gene therapy trials. Currently no applications for gene therapy trials have been received.

(Last reviewed by the Competent Authority: 1 October 2010)