The 2019 Annual Report of the State Agency of Medicines

The State Agency of Medicines (hereinafter – Agency) has published its Annual Report of the year 2019 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 209 new medicines,
• Agency carried out a total of 168 medicines renewal procedures,
• issued 7910 authorisations for import, export, transit and distribution of medicines,
• 42 authorisations for conduct of clinical trials,
• 259 clinical trials took place in Latvia in 2019,
• 543 adverse drug reaction reports were received,
• Medicines Examination Laboratory tested 94 samples of medicines; 94 samples of purified water produced in pharmacies were selected and tested, 223 volumetric solutions, indicators and reagents were prepared,
• identification of non-compliant medical devices in use in Latvia and vigilance or safety monitoring measures were ensured in 263 cases,
• 180 Certificates of Pharmaceutical Product and 8 Certificates of Free Sale for medicinal products were issued, as well as the Agency issued 19 Certificates of Free Sale for medical devices produced in Latvia,
• received 16 applications for cost-effectiveness analysis of medicines with new non-proprietary names or medicines containing new combinations of active substances; received 15 applications for approval or re-assessment of new medical technologies,
• 220 licenses for the activity of pharmacies, 35 licenses for medicines wholesalers, 16 licenses for medicines manufacturing or import and 2 licenses for manufacturing of the active substances were issued,
• 20 inspections of Good Manufacturing Practice (GMP) and 40 Good Distribution Practice (GDP),
• compliance evaluation of 5 blood and blood component establishments, 14 inspections of hospital blood banks and 16 centres for procurement of tissues and cells, as well as tissue centres.

Fom 1 June 2019, the Agency started to carry out new functions after taking them over from the National Health Service. The Agency took over the approval and evaluation of medical technologies utilised in healthcare and assessment of cost-effectiveness of medicinal products, medical devices and medical technologies utilised in healthcare.

By emphasizing the achievements of the last year, we would like to point out also:

• In 2019 the Agency was recognised as the leader of the “Consult First” initiative and was also the winner in the nomination “Merchant’s Choice”.
• Last year important pilot project was launched – assembly and processing of information regarding remaining stock of medicinal products available to wholesalers.
• Significant step towards the era of modern technology was the transfer of information regarding marketing authorisation and renewal of medicinal products, as well as annulment of marketing authorisation to the Agency’s website. Now this information is easily available online.
• Since last year marketing authorisation holders can submit an electronic report regarding disruptions in the supply of medicinal products via the Agency’s website.
• The Agency has invited pharmaceutical companies to submit their license documents electronically. Last year, the number of documents received electronically has increased by 50%.
• Improvements were made also to the Medicinal Product Register of Latvia – a new icon “KZS R” was introduced to denote reference medicinal products or the cheapest medicinal product with equivalent efficacy included in the List of Reimbursable Medicinal Products. Also the Register was supplemented with information regarding use of active substances in elderly patients.
• Last year the Agency started working on a project of state significance – amendments to prescription of reimbursable medicinal products, thus, allowing to decrease patient co‑payments for medicinal products. The Agency was designated as a collaboration partner of the Ministry of Health in the informative campaign.
• The Director of the Agency was elected as a member of the Management Group for the Heads of Medicines Agencies (HMA).
• 2019 will go down in history as the year for initiation of medicinal product verification both in Latvia and in Europe.
• Last year increased Agency’s participation in European medicines registration procedures: Latvia ensured marketing authorisation and renewal of 25 medicinal products via mutual recognition procedures (MRP) and decentralised procedures (DCP) as a Reference Member State.
• Latvia was the leading member state in European single assessment procedures of Periodic Safety Update Reports (PSUSA) for 11 active substances and the lead member state for signal monitoring for 30 active substances.
• Last year, Agency’s experts had the opportunity to participate in training cycles for raising qualification and exchange programs as part of the international collaboration program. 
• LEAN approach was also implemented in the work organisation and process management of the Agency.

The 2019 Annual Report is available on the website of the Agency, in the section “About us > About the Agency > Annual Report”.