The experts of the Institute provide scientific expertise on quality, preclinical and clinical documents and issue opinions. The specialist experts of the division provide expertise on dossiers for medicinal products submitted under the national procedure (NP), the decentralised procedure (DCP), and variations to the terms of the marketing authorisation. The Institute provides the facilities for these activities, recruits and trains new specialist experts, provides development opportunities for the experts, and, where necessary, the experts participate in the work of European Medicines Agency (EMA) committees and other international activities.
The Institute may develop activities and competences dedicated to specific pharmacotherapeutic groups of medicines, herbal medicinal products, pharmacovigilance, etc. Specialists from other LSMU departments, including the Veterinary Academy and the Faculty of Pharmacy may be engaged in the activities where necessary.
Database development and the collection and analysis of data on the safety of medicinal products. Large-scale post-authorisation studies of medicinal products. Pharmacoepidemiology includes monitoring the safety and efficacy of authorised and marketed medicinal products and pharmacovigilance.
Conducting pharmacoeconomic analysis of the pharmaceutical market, formulating trends, and providing recommendations to the competent state authorities and pharmaceutical companies.
The main function is to share equipment, experience and orders, and to provide qualified and quality services.