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Gene Therapy Legislation in Estonia

So far no clinical gene therapy trials have been conducted in Estonia. The clinical trials are regulated by the Medicinal Products Act. Authorization for the conduct of a clinical trial of a medicinal product is granted by the State Agency of Medicines (SAM). The SAM is the National Drug Regulatory Authority for Human and Veterinary Products and Competent Authority for Medical Devices in Estonia. SAM has the following obligations: marketing authorization and quality control of medicinal products including biological products, evaluation and approval of applications for clinical trials, import and export authorization of medicinal products, control of licit use of psychotropic and narcotic substances, control over precursors, drug information, advertising and promotion control and pharmaceutical inspection.

The competent authority involved in regulating the use of genetically modified organisms (GMOs) is the Ministry of Environment (MoE, Nature Protection Department). Under MoE an advisory body – Gene Technology Committee – is established that consults governmental institutions in regard of GMOs and gene tehnology. The Labour Inspectorate under Ministry of Social Affairs is responsible for issuing licences for use of genetically modified micro-organisms in contained use.

(Last reviewed by the Competent Authority: 22 June 2011)