Competences of the Institute in the area of human medicines - appropriate standards of quality, safety and efficacy.
International Activities - 16%16.11.2007 12:36:55
International activities of the State Institute for Drug Control consist in co-operation with EU institutions, EU Member states and international organizations active in the field of pharmaceuticals. The employees of the State Institute for Drug Control actively participate in the work of more than 40 committees and working groups of the European Medicines Agency (EMEA), European Commission (EC), European Directorate for the Quality of Medicines and Healthcare), Council of Europe, World Health Organization (WHO), Organization for Economic Co-operation and Development (OECD) and working initiatives of the network of EU medicines regulatory authorities. Given the regular attendance of experts the State Institute for Drug Control co-operates actively on the processes within EU and EEA and simultaneously joins many projects within the centralized network.
Pharmacovigilance - 13%16.11.2007 15:18:28
Post-authorisation surveillance over medicinal products aimed at ensuring a maximum safety and as beneficial a risk/benefit ratio of the medicinal product as practicable. These activities include the detection, evaluation, understanding, and prevention of adverse drug reactions or problems, such as misuse or abuse of medicines, drug interactions, effects on foetus, breast-fed babies, etc.
Analyses of pharmaceuticals required by law (e.g. from random controls of pharmaceuticals on the market, batch release), requested by other sections of the Institute or where applicable, by state administration bodies or within the framework of international cooperation. The laboratories are members of the international General Network of Official Medicines Control Laboratories. The laboratories do not perform analyses upon request from any commercial entity (except for batch release as stipulated by the Act on Pharmaceuticals). The pharmacopoeial section is involved in the publication of Czech Pharmacopoeia and in the preparation of European Pharmacopoeia.
Guidelines and Forms - 7%16.11.2007 14:40:51
General questions - 7%29.01.2008 15:45:49
Guidelines and Forms - 7%16.11.2007 14:59:47
History and Present - 7%21.11.2007 15:16:49
Guidelines and forms - 6%14.12.2007 13:47:10
Guidelines and Forms - 6%16.11.2007 15:42:43
SÚKL Information for Marketing Authorisation Holders on the EU Synchronisation of PSUR submission schemes of medicinal products authorised through national, mutual recognition and decentralised procedures.
Related webpages - 5%16.11.2007 15:34:55
SUKL Bulletin - 5%19.11.2007 10:24:33
SUKL Bulletin has been published on a monthly basis by the State Institute for Drug Control in cooperation with Prof. Skarnitzl’s Foundation since 1994. It provides information on pharmaceuticals and on medical devices to healthcare professionals and pursuant to Act No 79/1997 Coll., on Pharmaceuticals, as amended, serves for the publication of issued decisions on marketing authorisations of medicinal products.