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The 2018 Annual Report of the State Agency of Medicines


The State Agency of Medicines has published its Annual Report of the year 2018 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 189 new medicines,
  • Agency carried out a total of 241 medicines renewal procedures,
  • issued 7153 authorisations for import, export, transit and distribution of medicines,
  • 67 authorisations for conduct of clinical trials,
  • 285 clinical trials took place in Latvia in 2018,
  • 659 adverse drug reaction reports were received,
  • Medicines Examination Laboratory tested 103 samples of medicines; 91 samples of purified water produced in pharmacies were selected and tested, 302 volumetric solutions, indicators and reagents were prepared,
  • 777 notifications regarding release of medical devices on the market were received and evaluated,  
  • 185 Certificates of Pharmaceutical Product and Certificates of Free Sale for medicinal products were issued, as well as the Agency issued 19 Certificates of Free Sale for medical devices,
  • 239 licenses for the activity of pharmacies, 33 licenses for medicines wholesalers, 13 licenses for medicines manufacturing or import and 1 license for manufacturing of the active substances were issued,
  • 18 inspections of Good Manufacturing Practice (GMP) and 44 Good Distribution Practice (GDP),
  • compliance evaluation of 2 blood and blood component establishments, 25 inspections of hospital blood banks and 19 centres for procurement of tissues and cells, as well as tissue centres.

The 2018 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”.