State Agency of Medicines – National Drug Regulatory Authority for Human and Veterinary Products in Estonia
Estonian Centre on Medicines (ECM) was set up by the Ministry of Health in May 1991, before Estonian independence was restored. The initiative was supported by the Nordic Council on Medicines (Nordiska Läkemedelsnämnden - NLN), an umbrella organisation for the Nordic national drug regulatory authorities these days. Through NLN a small educational project supported by the Nordic Council of Ministers was launched to educate the ECM staff during 1991-1992. By creating the State Agency of Medicines (SAM) in 1993 the Government finalized the structure of the drug regulatory authorities in Estonia.
Estonian State Agency of Medicines was actively participating in the CADREAC collaboration before joining the EU. One of the aims of the Collaboration Agreement between Drug Regulatory Authorities in European Union Associated Countries was to facilitate the implementation of the EU standards and professional obligations to drug regulation practice prior to the accession. This gave valuable experience for the following waves of EU enlargement.
Currently the SAM is an agency under the Ministry of Social Affairs as during the governmental reform the former Ministry of Health was joined with the Ministry of Social Affairs. SAM has the following obligations: marketing authorisation and quality control of medicinal products including biological products, evaluation and approval of applications for clinical trials, import and export authorisation of medicinal products, control of licit use of psychotropic and narcotic substances, control over precursors, drug information, advertising and promotion control and pharmaceutical inspection. Drug utilisation data are collected by SAM and reports generated on the country level. In 2000, the control of medical devices and veterinary medicines was added to the Agency’s responsibilities. Since 2010 the area of medical devices was added to the responsibilities of the newly formed Health Board.
The requirements for medicinal products in Estonia are based on the respective EU legislative acts. The control over narcotic and psychotropic substances and precursors is carried out according to the UN Single Convention on Narcotic Drugs of 1961, UN Convention on Psychotropic Substances of 1971 and UN Convention against Illicit Traffic in Narcotic Drugs and Psychotropic Substances. In addition, precursors are regulated in Estonia according to the EU legislation.
Today, the SAM is an active member of the EU drug regulatory network, contributing to the decentralised, mutual recognition and centralised marketing authorisation procedures and other functions. The SAM also provides technical support to the Ministry in preparation of the positions on the national and EU legislative initiatives.