The 2016 Annual Report of the State Agency of Medicines

The 2016 Annual Report of the State Agency of Medicines

The State Agency of Medicines (SAM) has published its Annual Report of the year 2016 which summarizes 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 272 new medicines,
• SAM carried out a total of 214 medicines renewal procedures,
• issued 6854 authorisations for import, export, transit and distribution of medicines (including authorisations for distribution of unauthorized medicines and authorisations for distribution of parallel imported medicines),
• 76 new authorisations issued for conduct of clinical trials,
• 288 clinical trials took place in Latvia in 2016,
• 341 adverse drug reaction reports were received,
• the Laboratory tested 107 samples of medicines; 96 samples of purified water produced in pharmacies were selected and tested, 431 volumetric solutions, indicators and reagents were prepared,
• 269 announcements of medical devices placement on the market were received and information on them was entered in LATMED medical device database,
• 147 Certificates of Pharmaceutical Product and 29 Certificates of Free Sale were issued,
• 310 licences for the activity of pharmacies, 52 licences for medicines wholesalers, 19 licences for medicines manufacturing or import and 4 licenses for manufacturing of the active substances were issued.

Svens Henkuzens, the Director of the State Agency of Medicines: “Alongside with the performance of basic activities, the following priorities were set for 2016: firstly, minimising the impact of risks created by disruptions in the supply of medicines in Latvia, secondly, resources were allocated for strengthening communication with the stakeholders representing pharmaceutical companies and general public, thirdly, attention was brought to the improvement of information technologies and their effective use.”

It should also be mentioned that continuous development of the quality management system was performed, and at the end of 2016 quality management system was assessed as compliant with the new 2015 ISO 9001 standard and the ISO/IEC 27001:13 information security standard by Bureau Veritas Latvia.

In 2016 the State Agency of Medicines also celebrated 20th anniversary of the foundation of the Agency.

The 2016 Annual Report of the State Agency of Medicines is available in the section “Publications” on the SAM website.