30.06.2022.
The State Agency of Medicines has published its Annual Report of the year 2021 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 383 new medicines,
- issued 9117 authorisations for import, export, transit and distribution of medicines,
- 53 authorisations for conduct of clinical trials,
- 226 clinical trials took place in Latvia in 2021,
- 3929 adverse drug reaction reports were received,
- Medicines Examination Laboratory tested 81 samples of medicines; 548 medicinal product quality parameters, 228 volumetric solutions, indicators and reagents were prepared, 73 samples of purified water produced in pharmacies were selected and tested;
- vigilance or safety monitoring measures for medical devices in use in Latvia were ensured in 296 cases,
- 157 Certificates of Pharmaceutical Product and 14 Certificates of Free Sale for medicinal products were issued, as well as the Agency issued 28 Certificates of Free Sale for medical devices produced in Latvia,
- 363 licenses for the activity of pharmacies, 35 licenses for medicines wholesalers, 12 licenses for medicines manufacturing or import and 4 licenses for manufacturing of the active substances were issued,
- 14 inspections of Good Manufacturing Practice (GMP) and 27 Good Distribution Practice (GDP),
- compliance evaluation of 4 blood and blood component establishment, 10 inspections of hospital blood banks and 8 tissue centres,
- 44 opinions regarding therapeutic efficacy and cost-effectiveness assessment of medicines with new non-proprietary names or medicines containing new combinations of active substances were provided,
- 30 decisions regarding approval of medical technologies.
The 2021 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”.
