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Supplies of medicines – with focus on active substances - 35%
31.05.2012 10:42:10Summary information on prices and quantities of distributed and supplied medicines with breakdown by the contained active substances.
Supplies of medicines – with focus on medicinal products - 34%
1.06.2012 14:02:57Summary information on prices and quantities of distributed medicines according to the code of SUKL according to the reports by distributors.
Human medicines - Czech Republic/EU - 28%
13.12.2007 12:25:45Competences of the Institute in the area of human medicines - appropriate standards of quality, safety and efficacy.
Notification of the commencement of distribution activities within the territory of the Czech Republic based upon distribution authorization for medicinal products issued by another EU member state - after Brexit - 18%
15.03.2021 10:00:54State Institute for Drug Control hereby informs UK WDL holders providing distribution activities within the territory of the Czech Republic upon distribution authorization for medicinal products issued by Medicines & Healthcare products Regulatory Agency, UK about changes of conditions after Brexit.
Amendment to the reimbursement decree – payments for marketing authorisation variations effective as of 15 October 2013 - 18%
11.10.2013 10:57:00On 15 October 2013, the amendment to decree no. 427/2008 Coll., on determination of the amount of costs to be reimbursed for specialised tasks performed by the State Institute for Drug Control and the Institute for State Control of Veterinary Biologicals and Medicines (the “reimbursement decree”), has come into effect.
Amendment to the Reimbursement Decree effective as of 1 June 2019 - 16%
27.05.2019 10:50:44On 1 June 2019, amendment to Decree No 427/2008 Coll., on determination of the amount of costs to be reimbursed for specialised tasks performed by the State Institute for Drug Control and the Institute for State Control of Veterinary Biologicals and Medicines, amending reimbursements of costs in the sphere of clinical trials.
International Activities - 15%
16.11.2007 12:36:55International 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 - 12%
16.11.2007 15:18:28Post-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.
Payments for variations submitted before the effective date of the reimbursement decree (effective as of 15 October 2013) - 12%
7.10.2013 08:59:59The State Institute for Drug Control hereby informs of the rules of reimbursement of costs of marketing authorisation variations applied for before the effective date of the amended Decree No. 427/2008 Coll., on determination of the amount of costs to be reimbursed for specialised tasks performed by the State Institute for Drug Control and the Institute for State Control of Veterinary Biologicals and Medicines (the “reimbursement decree”), i.e. until 14 October 2013.
Laboratory activities and pharmacopoeias - 12%
19.11.2007 09:28:39Analyses 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.
Pharmacopoeia - 12%
30.12.2010 09:32:00A pharmacopoeia is an essential pharmaceutical work of standardisation nature, which helps to ensure safe, effective, and quality pharmaceuticals. Responsibility for the accuracy of pharmacopoeia texts lies with the Pharmacopoeia Commission of the Ministry of Health of the Czech Republic, which cooperates with the European Pharmacopoeia Commission, whose member the Czech Republic has been since 1998. Pharmacopoeia The operation of the Pharmacopoeia Commission of the Ministry of Health of the Czech Republic and its expert sections is organised by the Technical Secretariat of the Pharmacopoeia Commission, which organisationally and materially forms part of the Department of Pharmacopoeia and Standardisation of Medicines of SÚKL (LKS).
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