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Gene Therapy Legislation in Poland

The Competent Authority for GMOs in Poland is the Minister of the Environment. In a publicly available register supervised by the Minister of the Environment there is information on competent authorities, legal acts (both Polish and EU), procedures and documents necessary to provide for any GMO trial, guidance notes for applicants, formats of application forms, submitted applications, decisions in place and other. According to the Act Pharmaceutical Law, the Competent Authority for clinical trials is the Minister of Health.

In case of clinical trials with GMOs it is necessary to obtain the Minister's of Health consent, the Ethics Committee's opinion and consent by the Minister of the Environment for the use of GMOs. All clinical trials with GMOs in Poland are treated as the contained use of GMOs. Therefore the EU legal regime, namely Directive 2009/41/EC is at stake in case of clinical trials with GMOs. All such decisions are available to the public at: gmo.mos.gov.pl. Currently there are registered clinical gene therapy trials in Poland.

(Last reviewed by the Competent Authority: 17 June 2011)