The 2015 Annual Report of the State Agency of Medicines

03.08.2016.

The State Agency of Medicines (SAM) has published its Annual Report of the year 2015 which summarizes information regarding the operation of the Agency during the previous year.

Svens Henkuzens, the Director of the State Agency of Medicines: “2015 has been a year filled with challenges for the State Agency of Medicines. Latvia assumed the responsibilities of the presiding member state of the Council of the European Union and the State Agency of Medicines organized seven events within the collaboration network of pharmaceutical regulatory authorities in Europe. The Latvian presidency was an opportunity to influence processes and priorities on the European Union agenda and to prove that the State Agency of Medicines is an equal partner within the collaboration network of European agencies.”

Some of the numbers that show Agency’s achievements last year:

Marketing authorisations were issued for 348 new medicines;
4594 authorisations were issued for distribution of unauthorized medicines in the Republic of Latvia;
More than 1684 authorisations were issued for import/export of narcotic, psychotropic medicines/substances and precursors;
124 authorisations were issued for distribution of parallel imported medicines;
78 new authorisations were issued for conduct of clinical trials;
286 clinical trials took place in Latvia in 2015;
314 adverse drug reaction reports were received;
The Medicines Examination Laboratory tested 104 samples of medicines, 104 samples of purified water and prepared 432 volumetric solutions, indicators and reagents upon requests from pharmacies;
249 announcements were registered regarding medical devices’ placement on the market of the Republic of Latvia;
137 Certificates of Free Sale and 22 Certificates of Pharmaceutical Product were issued;
330 licences for the activity of pharmacies, 44 licences for medicines wholesalers, 10 licences for medicines manufacturing or import and 2 licenses for manufacturing of the active substances were issued.

The 2015 Annual Report of the State Agency of Medicines is available in the section “Publications” of the SAM website www.zva.gov.lv.