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The 2022 Annual Report of the State Agency of Medicines

04.07.2023.

The State Agency of Medicines has published its Annual Report of the year 2022 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 410 medicines,
  • issued more than 10 thousand authorisations for distribution of medicines,
  • 40 authorisations for conduct of clinical trials; 221 clinical trials took place in Latvia in 2022,
  • 802 adverse drug reaction reports were received,
  • Medicines Examination Laboratory tested 78 samples of medicines and 517 medicinal product quality parameters;
  • vigilance or safety monitoring measures for medical devices in use in Latvia were ensured in 168 cases,
  • 192 licenses for the activity of pharmacies, 36 licenses for medicines wholesalers, 14 licenses for medicines manufacturing or import and 3 licenses for manufacturing of the active substances were issued,
  • 14 inspections of Good Manufacturing Practice (GMP) and 29 Good Distribution Practice (GDP),
  • compliance evaluation of 1 blood and blood component establishment, 17 inspections of hospital blood banks and 8 tissue centres,
  • 49 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,
  • 14 decisions regarding approval of medical technologies,
  • 2 Certificates of Free Sale and 238 Certificates of Pharmaceutical Product for medicinal products were issued, as well as the Agency issued 37 Certificates of Free Sale for medical devices manufactured in Latvia.

 

The 2022 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”.