The 2013 Annual Report of the State Agency of Medicines provides insight in the operation of the Agency

The 2013 Annual Report of the State Agency of Medicines provides insight in the operation of the Agency

The State Agency of Medicines (SAM) has published its Annual Report of the year 2013 which summarises information regarding the operation of the Agency during the previous year.

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

• Marketing authorisations were issued for more than 300 new medicines;
• More than 9000 variations were made to marketing authorisations of medicines;
• More than 3500 authorisations were issued for distribution of unauthorised medicines in the Republic of Latvia;
• More than 1400 authorisations were issued for import/export of narcotic, psychotropic medicines/substances and precursors;
• More than 110 authorisations were issued for distribution of parallel imported medicines;
• 59 new authorisations for conduct of clinical trials were issued in 2013;
• A total number of 237 clinical trials in Latvia in 2013;
• 375 adverse drug reaction reports were received;
• The Medicines Examination Laboratory tested 130 samples of medicines, 103 samples of purified water and prepared 500 volumetric solutions, indicators and reagents upon requests from pharmacies in 2013;
• 353 announcements were registered regarding medical devices’ placement on the market of the Republic of Latvia;
• 47 Certificates of Free Sale and 51 Certificates of Pharmaceutical Product were issued;
• Licences were issued to 248 pharmacies and 27 medicines wholesalers.

Employees of the SAM will remember 2013 as a dynamic year filled with professional challenges. It was related to an active international cooperation, several changes in the normative acts on a national and European level, as well as increasing the quality and effectiveness of operation within the Agency.

Safety of medicines was one of the main messages that we conveyed to the public in 2013 by carrying out an informative campaign “REVEAL THE OTHER SIDE OF MEDICINES”. The respective therapeutic effect of any medicine is unquestionable issue; however, medicines can also cause adverse reactions. The Agency gathers and analyses adverse drug reaction reports received from doctors, pharmacists and since 2013 - also from patients.

In addition to the main activities the SAM has made a great investment in the development of the quality management system in 2013 – a surveillance audit of the Agency’s integrated management system was carried out in accordance with the ISO 9001:2008 and ISO/IEC 27001:2005 international standards and the Benchmarking of European Medicines Agencies was also conducted.

The 2013 Annual Report of the State Agency of Medicines is available in the section “Publications” of SAM website www.zva.gov.lv.