Ravimiametils

Ravimiametils refers to the Estonian State Agency of Medicines, often abbreviated as SAM. It is the national regulatory authority responsible for the supervision of medicinal products and medical devices in Estonia. The agency's primary mission is to ensure the quality, safety, and efficacy of medicines and medical devices available on the Estonian market. SAM operates under the Ministry of Social Affairs of Estonia and plays a crucial role in protecting public health.

The responsibilities of Ravimiametils include granting marketing authorizations for medicinal products, inspecting pharmaceutical manufacturers and wholesalers, and monitoring the pharmacovigilance of medicines. This involves collecting and assessing information on adverse drug reactions to ensure the safe use of pharmaceuticals. The agency also oversees the pricing and reimbursement of medicines, contributing to their accessibility for patients. Furthermore, Ravimiametils is involved in the regulation of clinical trials and the approval of their protocols. In its capacity, the agency contributes to the harmonization of medicinal product regulation within the European Union through its cooperation with the European Medicines Agency (EMA) and other national competent authorities.