28.06.2024.
The State Agency of Medicines has published its Annual Report of the year 2023 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 378 medicines,
- issued more than 9 thousand (9907) authorisations for distribution of medicines,
- 49 authorisations for conduct of clinical trials; 210 clinical trials took place in Latvia in 2023,
- 362 adverse drug reaction reports were received,
- Medicines Examination Laboratory tested 55 samples of medicines and 359 medicinal product quality parameters,
- vigilance or safety monitoring measures for medical devices in use in Latvia were ensured in 201 cases,
- 193 licenses for the activity of pharmacies, 26 licenses for medicines wholesalers, 9 licenses for medicines manufacturing or import and 2 licenses for manufacturing of the active substances were issued or renewed,
- 13 inspections of Good Manufacturing Practice (GMP) and 25 Good Distribution Practice (GDP),
- compliance evaluations of 2 blood and blood component establishments, 2 inspections of hospital blood banks and 11 inspections of tissue centres and 1 inspection of an organ transplantation centre,
- 47 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,
- 11 decisions regarding approval of medical technologies,
- 4 Certificates of Free Sale and 265 Certificates of Pharmaceutical Products for medicinal products were issued, as well as the Agency issued 32 Certificates of Free Sale for medical devices manufactured in Latvia, thus, promoting export of medicinal products authorised in Latvia and of medical devices,
- in 7 cases, the Agency made a decision to pay compensation for severe and moderate health damage caused by the adverse drug reactions of vaccines against COVID-19 infection.
Previous Annual Reports of the State Agency of Medicines are available on the website of the Agency, in the section “About us > About the Agency > Annual Report”.
