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Search for: Státní ústav pro kontrolu léčiv (SÚKL) uvádí na pravou míru mylné a zavádějící informace, které uvedla v článku „Kmenové buňky pro diabetiky: proplácení se odkládá“ redaktorka Lenka Petrášová.
Implementation of Variations to, Renewals and Transfers of Marketing Authorisations - 1%
10.12.2021 12:04:00With a view to frequent questions from marketing authorisation holders, SÚKL hereby provides more details on the implementation of variations to marketing authorisations, including the specifics of individual types of variations, as well as information regarding the implementation of marketing authorisation renewals and transfers. The information provided herein is applicable to medicinal products authorised via national procedures as well as MRP/DCP.
Change concerning the submitting of applications for renewal of marketing authorisation - 1%
21.03.2013 13:06:20The State Institute for Drug Control (SÚKL) hereby informs of a change concerning the submitting of applications for renewal of marketing authorisation introduced by the amended Act on Pharmaceuticals.
Information on the EU Synchronisation of PSUR submission - 1%
11.04.2007 14:59:07SÚKL Information for Marketing Authorisation Holders on the EU Synchronisation of PSUR submission schemes of medicinal products authorised through national, mutual recognition and decentralised procedures.
Pharmaceuticals - supply, sales and preparation - 1%
16.11.2007 14:20:42This 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.
Pharmacopoeia - 1%
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).
Field Safety Corrective Actions in 2012 - 1%
20.03.2012 17:32:29Field Safety Corrective Actions (FSCAs) are actions taken by manufacturers to reduce a risk of death or serious deterioration in the state of health associated with the use of a medical device. The FSCAs may include e.g. withdrawal of medical devices (hereinafter referred as the „MDs“) or supplementary information for use of MD. The manufacturer informs about Field safety Corrective Action via a Field Safety Notice (FSN).
Field Safety Corrective Actions in 2011 - 1%
20.03.2012 17:29:21Field Safety Corrective Actions (FSCAs) are actions taken by manufacturers to reduce a risk of death or serious deterioration in the state of health associated with the use of a medical device. The FSCAs may include e.g. withdrawal of medical devices (hereinafter referred as the „MDs“) or supplementary information for use of MD. The manufacturer informs about Field safety Corrective Action via a Field Safety Notice (FSN).
Application for approval to import a medicinal product from a third country - 1%
2.11.2022 15:14:08The distributor has a legal obligation to import a non-authorised medicinal product from a third country, based on the prescription of this product by a physician, only after the approval of the State Institute for Drug Control.
Application Form for Approval of Placing a Foreign-Language Batch of Medicinal Product on the Market - 1%
1.11.2022 09:00:00An electronic form is used to submit an application to enable the introduction of individual batches of a medicinal products on the market when the packaging information is in a language other than Czech.
Obligations Applicable to Holders of Centralised Marketing Authorisations - 1%
10.05.2013 14:36:40Obligations applicable to Marketing Authorisation Holders of Products Authorised via the Centralised Procedure in relation to State Institute for Drug Control.
Ethics Committees for Multicentric Clinical Trials - 1%
5.12.2018 15:04:00In compliance with Section 54 of Act No 378/2007 Coll. on Amendment to the Act on Pharmaceuticals and on Amendments to Other Acts, applications for opinions on multicentric clinical trials are also submitted to the following Multicentric Ethics Committees.
The recommended procedures – update 9.10.2018 - 1%
15.10.2018 06:07:00The recommended procedures for submitting correct and complete reporting of marketing authorization holders on the volume of supplies of human medicinal products placed on the market in the Czech Republic (REG-13)
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