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Published aricles: 86


Guidelines EMA, EC, CMD and HMA


Ethic Committies


Central contacts


Mail room – cash desk


Organisational Structure

Organisational Structure  


Information on SUKL


Bank Account

   


Guideline for Administrative Fees


List of holders of GLP Certificate

   


List of holders of GMP Certificate


List of distributors of medicinal products

   


Clinical trials database

   


Database of Non-intervention post-marketing study


Related webpages


Distribution of pharmaceuticals

Control over compliance with legislative requirements in the area of distribution of pharmaceuticals, focusing upon the principles of Good Distribution Practice (GDP) and, furthermore, issuance of distribution authorisations.  


Pharmacovigilance

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.  


Pharmaceuticals - supply, sales and preparation

This area includes supervision over compliance with legal requirements. The supervised entities are pharmacies, vendors of selected pharmaceuticals, and specialised workplaces of healthcare facilities. The control of handling medicinal products is also conducted in all healthcare facilities. Controls are provided for by the concerned regional offices of SÚKL.  


Contacts

   


FAQ


Related information


Clinical trial on pharmaceuticals

Assessment of applications for authorisation/notification of clinical trials, surveillance over the conduct of clinical trials, issuance of opinions for project assessment, unless clinical trials regulated by SUKL are concerned, and registration of use of non-authorised medicinal products.  


Manufacture of pharmaceuticals


Good laboratory practices


Guidelines and Forms


Surveillance over the manufacture of pharmaceuticals

Surveillance activities in the area of manufacture of pharmaceuticals, good clinical and laboratory practices. It includes the activities in the area of addressing quality defects of pharmaceuticals and excipients available on the Czech market,   the issuance of binding opinions on the import and export of medicinal products, incl. cooperation with customs authorities  


Contacts


FAQ


Basic information


Quality defects and enforcement

Department solves quality defects of active or secondary substance s and perform es safety precautions for human health prevention . Departement identif ies illegal conduct and gives sanction s for such conduct and enforce s law in cases where an illegal situation has been identified. Unauthorised handling of pharmaceuticals includes manufactur ing , import, distribution, supply ing or sale, preparation and parallel import of medicinal products without an effective authorisation or licence, incl. the conduct of the clinical trial and the conduct of activities of the control laboratory without appropriate authorisations or notifications. In its enforcement activities the Institute cooperates with other institutions in the Czech Republic and abroad (in particular with the Czech Police, Customs Administration, Czech Agriculture and Food Inspection Authority (CAFIA), and control authorities of the EU Member States).  


Forbidden plants or other substances


Related information


Guidelines and Forms


Declaration


Surveillance in the area of advertising

The conduct of surveillance over compliance with Act No 40/1995 Coll., on Advertising Regulation, as amended (the Act) in the area of advertising for medicinal products for human use and sponsoring in this area (with the exception of radio and television broadcasting). Investigation of reports of defective advertisements for medicinal products for human use, issuance of expert opinions on advertising materials and advertising   regulation issues. The Act is binding for the sponsors, producers and distributors of advertising, but also for healthcare professionals, e.g. in the cases where they participate in sponsored or advertising events (e.g. expert meetings, scientific conferences, etc.), where promotion samples are used, and advertising materials for medicinal products are provided to patients. SÚKL does not perform surveillance over the area of advertising for foodstuffs (dietary supplements).  


Related information


Related webpages

   


Guidelines and forms


Pharmacopoeial publications

A 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.  


Borderline products

The issuance of opinions/decisions in cases where doubts arise as to whether a product is a medicinal product subject to marketing authorisation or an active substance or another product or, where applicable, a homeopathic product.  


Laboratory activities and pharmacopoeias

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.  


Related information


Regulation of prices and reimbursements for pharmaceuticals

Decision-making in the area of maximum prices of medicinal products and the amounts and conditions of reimbursements for medicinal products. The process of determining the maximum prices and amounts and conditions of reimbursements is individual and may be re-visited, it is conducted in the mode of an administrative procedure with fixed timelines and fully complies with the European transparency directive. Applications and initiatives will be reviewed in particular on the basis of efficacy, safety, and cost efficiency assessments. The parties to the administrative procedure are, pursuant to the law, health insurance companies and marketing authorisation holders. Initiatives may be submitted also by patient organisations or professional associations.  


Publication activities

SÚKL Bulletin is published on a monthly basis and it provides information on the activities of SÚKL and on the development of regulatory measures in the area of pharmaceuticals and medical devices. In July and August, a special edition of SÚKL Bulletin is published providing a list of pharmacies, manufacturers, distributors of medicinal products, and a list of OTC products   and products containing addictive substances. The Annual Report is published early in the year and contains an overview of all information about the activities of SÚKL. The bulletin “Farmakoterapeutické informace” (Pharmacotherapeutic information) is published on a monthly basis and as an independent drug bulletin it is a member of the International Society of Drug Bulletins (ISDB).  


Administrative activities

The mail-room serves for the receipt of any documentation within the scope of administrative procedures and data messages.  


Legislation and guidelines

Legislation for regulation of pharmaceuticals from the view of quality, safety and efficacy.      


Contacts


Information on Marketing Authorisation


Marketing authorisation of pharmaceuticals

Any proprietary medicinal product is subject to marketing authorisation prior to its placement on the market in the Czech Republic. The marketing authorisation procedure includes an assessment of a dossier, in which the future marketing authorisation holder (MAH) evidences the safety, efficacy, and quality of the product. Furthermore, the indications, contraindications, dosage of the product, general classification for supply, as well as the package leaflet for the patient and proposed texts on the labelling of the medicinal products are assessed. The Summary of Product Characteristics (SPC) forms part of the marketing Authorisation. It serves as the key source of information about the medicinal product for doctors and healthcare professionals.  


Related Information


RSS

RSS channel for delivery the News from this website.  


Sitemap


Contacts


Accessibility


Webmaster


Paticka/eng


Information Service


Supplies of medicinal products


Reports to SUKL


Reviews and lists


Important Information


SUKL Activities


Career


Learning Centre


Public Procurement


International Activities

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.  


External Cooperatin

Within the scope of its operation, the State Institute for Drug Control actively collaborates with external partners who are members of workgroups or who prepare expert opinions, expert analyses, provide positions, consultations and reports for regulatory sections of the Institute.  


Fees


SUKL Notice Board

The mission of the State Institute for Drug Control is to ensure, for public health protection purposes, that only those pharmaceuticals which are of good pharmaceutical quality, efficacy, and safety, be applied in practice and during clinical trials, that quality and safe raw materials be used in the manufacture and preparation of pharmaceuticals, and that safe and functional medical devices with information describing objectively established properties be used and that data from the research of pharmaceuticals, raw materials, and devices be credible and obtained in an ethical manner.  


Pharmaceutical Industry


Public


Annual Reports


History and Present


Quality Policy of the Institute


Contact Persons


Contacts


Contents 2006


Contents 2005


SUKL Bulletin

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.  


Contents 2007


Guidelines and Forms

   


Guidelines and Forms


Guidelines and Forms