30.06.2021.
The State Agency of Medicines has published its Annual Report of the year 2020 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 and medicines renewal procedures were carried out for 371 new medicines,
- issued 8779 authorisations for import, export, transit and distribution of medicines,
- 65 authorisations for conduct of clinical trials,
- 243 clinical trials took place in Latvia in 2020,
- 921 adverse drug reaction reports were received,
- Medicines Examination Laboratory tested 88 samples of medicines; 638 medicinal product quality parameters were tested, 39 samples of purified water produced in pharmacies were selected and tested, 210 volumetric solutions, indicators and reagents were prepared,
- 19 announcements of Latvian medical device manufacturers and their medical devices were analysed and information on them was entered in LATMED medical device database,
- identification of non-compliant medical devices in use in Latvia and vigilance or safety monitoring measures were ensured in 266 cases,
- 175 Certificates of Pharmaceutical Product and 8 Certificates of Free Sale for medicinal products were issued, as well as the Agency issued 23 Certificates of Free Sale for medical devices produced in Latvia,
- 34 opinions regarding therapeutic efficacy and cost-effectiveness assessment of medicines with new non-proprietary names or medicines containing new combinations of active substances provided,
- 32 decisions regarding approval of medical technologies,
- 315 licenses for the activity of pharmacies, 30 licenses for medicines wholesalers, 15 licenses for medicines manufacturing or import and 3 licenses for manufacturing of the active substances were issued,
- 9 inspections of Good Manufacturing Practice (GMP) and 22 Good Distribution Practice (GDP),
- compliance evaluation of 1 blood and blood component establishment, 14 inspections of hospital blood banks and 8 tissue centres and 1 organ transplantation centre.
The 2020 Annual Report of the State Agency of Medicines is available on the website of the Agency, in the section “About us > About the Agency > Annual Report”.
