SIDC Mission
SIDC mission is the ensuring and control of the quality, efficacy and safety of medicinal products and medical devices, issuing the decisions of the registration of human medicines and issuing licences for activities with specified substances, performing the state supervision in the field of pharmacy, executing of state administration in the matters of drug antecedents, the control of manufacture and wholesale distribution of medicinal products and medical devices and the cooperation with the EU organisations.
In addition to above mentioned activities, SIDC carries out inspections of compliance with the principles of good manufacturing practice, good clinical practice, good distributing practice and good pharmacy practice and to the observance of provisions of the Slovak Pharmacopoeia and the Slovak Pharmaceutical Codex in the process of preparation of the mass- and individually-prepared medicines. Furthermore, SIDC compiles the Slovak Pharmacopoeia and the Slovak Pharmaceutical Codex (§45), imposes fines for shortcoming being disclosed and keeps the list of registered medicinal products and approved medical devices.
International cooperation is focused on the activities following the membership of the SR in the EU as well as on the development of the cooperation and the exchange of information with the member states of OECD.
Another important activity is the cooperation with the European Directorate for the Quality of Medicines (EDQM), in the view of the unified implementation of the quality system in the laboratories in the framework of the mutual recognition of the results, as well as the cooperation and the participation in the periodical sessions of the EMA.
The nominated employees participated in the regular sessions of the working groups and committees according to the requirements of the above mentioned organisations and agencies (EMA, EDQM, OECD, and EC – Pharmacopoeia Committee).
Within the international cooperation the special importance has the representation of the SIDC and SR by the expert lectures in the various international and domestic conferences, seminars and workshops, which are performed by the expert employees of SIDC.
