The State Agency of Medicines of Latvia (hereafter SAMLV) is a State institution under the supervision of the Ministry of Health of the Republic of Latvia. The operational objective of SAMLV is to implement local and international pharmaceutical legislation in order to ensure that the products (medicines, medical devices, blood, cells, tissues and organs) used in health care, as well as the involved companies and their activities comply with certain requirements; and in addition to provide objective and analytical information for the purposes of state administration, to the public, health care specialists, cooperation partners, as well as international and EU institutions.
Since 1st January 2013 SAMLV is operating in accordance with the Law on Public Agencies and the Law On Budget and Financial Management as an institution non-financed from the budget ensuring its operation only with the revenue from the provided paid services without receiving grants from the state budget. The SAMLV budget is approved by the Cabinet of Ministers in accordance with the Law On Public Agencies.
The operation of SAMLV is regulated by the State Administration Structure Law, Pharmaceutical Law, Law on Public Agencies, Cabinet of Ministers Regulation No. 537 "Statutes of the State Agency of Medicines" adopted on July 31st 2012 and other normative acts.
Functions of SAMLV:
- ensure that only effective, safe and qualitative medicinal products are included in the Drug Register by performing expertise on marketing authorisation/renewal and variations documentation;
- ensure inspection of compliance, certification and licensing of companies manufacturing and distributing medicinal products;
- monitor the safety of medicines consumption, control the quality of medicines and ensure risk minimisation measures;
- monitor import, export, transit and distribution of medicines in the state by issuing permits and gathering data on consumption of medicines;
- ensure evaluation of clinical trial projects for medicines, issue authorisation for conduct of clinical trials in Latvia and monitor their compliance;
- ensure evaluation of compliance, registration and monitoring of safety of medicinal devices, issue authorisation for conduct of clinical trials;
- carry out evaluation of compliance of procurement and storage organisations of human tissues, cells and organs, blood establishments and hospital blood banks;
- evaluate cost-effectiveness of medical technology;
- approve medical technology intended for use in healthcare, register approved medical technology, create and maintain record of approved medical technology and database of medical technology reimbursed from state budget;
- provide the public and specialists with objective and thorough information regarding medicines, their use and ensure data exchange;
- operate in the European medicines network by participating in work-sharing and complying with the collective standards and procedures, cooperate with other European and international organisations.
