Ravimiamet

Ravimiamet, the State Agency of Medicines, is Estonia's regulatory authority for medicines and medical devices. Operating under the Ministry of Social Affairs, it is responsible for protecting public health by ensuring the safety, quality and efficacy of medicinal products available in Estonia.

Its duties include granting and supervising licenses for pharmaceutical manufacturers, importers, distributors and wholesalers; evaluating and authorising medicines for market access; monitoring clinical trials; and enforcing post-market surveillance through pharmacovigilance activities. The agency conducts inspections and audits to verify compliance with good manufacturing practice (GMP), good distribution practice (GDP) and other applicable standards. It also regulates medical devices and cosmetic products to reflect EU rules and national requirements.

Ravimiamet participates in European Union regulatory processes through cooperation with the European Medicines Agency and other national authorities. It implements EU directives and maintains national procedures for assessing new medicines, handling adverse drug reaction reports and issuing safety warnings and product recalls. The agency also provides information to healthcare professionals and the public, and maintains official registries and databases on authorised medicines and medical devices in Estonia.

By coordinating with other health authorities, Ravimiamet aims to support safe access to medicines, ensure supply chain integrity, and facilitate legitimate trade while upholding consumer protection and public health goals in Estonia.