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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.
Applications for Transfers of Marketing Authorisations of Medicinal Products - 1%
25.08.2022 09:05:15SÚKL informs marketing authorisation holders about the aspects of submitting applications for transfers of the medicinal product marketing authorisations, including information on differences between marketing authorisation transfers effective as of the date when the decisions on the marketing authorisation transfers come into force or as of a future date. The provided information applies to medicinal products authorised via national procedures as well as MRP/DCP.
Surveillance over advertising for medicinal products for human use and other products - 1%
15.01.2008 23:00:37Pursuant to the Act on Advertising Regulation, surveillance over advertising is divided among individual surveillance authorities. The public, however, is not sufficiently aware of this. That is why in our practice we often face requirements for us to handle all reports of suspected defective advertising, but also defective information on the labelling of various products, which are not authorised medicinal products. SÚKL, however, is not entitled by law to conduct such activities.
Payment of costs for expert activities conducted upon request - 1%
28.12.2010 16:14:36The conditions and payment process for the reimbursement of costs for expert activities conducted upon request (Section 112 of Act No 378/2007 Coll., on Pharmaceuticals, as amended, and Section 27 of Act No 296/2008 Coll., on Safeguarding the Quality and Safety of Human Tissues and Cells Intended for Use in Man and on Amendments to Related Acts, and Section 94 of Act No 268/2014 Coll., on Medical Devices and on Amendments to Act No 634/2004 Coll., on Administrative Fees, as Amended) are stipulated in SÚKL guidelines UST-29 and UST-36. The currently effective versions of guidelines UST-29 and UST-36 specify the conditions and procedures applicable to the payment process for the reimbursement of costs for expert activities conducted upon request.
KLH-CTIS-01 - 1%
26.01.2022 11:44:40Version 2 of 15 May 2023 The Guideline SÚKL´s Ethics Committee and Multicentric Ethics Committees stipulates the requirements governing documents to be submitted with Part II of application for clinical trial authorisation :
Procedure for the Submission of Applications for Mutual Recognition of Marketing Authorisations with the Czech Republic Acting as the RMS - 1%
26.08.2019 09:54:20SÚKL hereby specifies the requirements governing the submission of applications for marketing authorisation mutual recognition procedures with the Czech Republic acting as the RMS (so called MRP/RUP-RMS).
Reminder of the method of provision of information upon suspension or termination of marketing of medicinal products - 1%
29.09.2015 15:29:48SÚKL hereby reminds marketing authorisation holders of the necessity to provide available information when reporting suspension or termination of marketing of a medicinal product in the Czech Republic.
Applications for Revocation of Marketing Authorisations of Medicinal Products - 1%
10.12.2021 06:00:00SÚKL hereby informs marketing authorisation holders about the aspects of submitting applications for revocation of the medicinal product marketing authorisations, including information on medicinal product recalls following the revocation of their marketing authorisations.
Applications for Changes of the Labelling or PIL Not Associated with SmPC (Type P Variations) - 1%
29.08.2022 10:31:34SÚKL informs marketing authorisation holders (MAH) about the aspects of submitting applications for changes of the labelling or PIL not associated with the SmPC (Notification under Article 61(3) of Directive 2001/83/EC and under Section 35(5) of the Act on Pharmaceuticals; so called Type P variations), incl. procedural differences between national and MRP variations and how to distinguish between them in specific cases.
Waiver of Reimbursement of Costs for Additional Strengths/Pharmaceutical Forms of a Particular Product upon Take-over of the Role of the RMS Due to Brexit - 1%
13.11.2018 06:00:00Upon request, SÚKL shall waive the payment of reimbursement of costs for additional strengths/pharmaceutical forms of a medicinal product in respect of which it will take over the role of the RMS from Great Britain in the period from 1 December 2018 to 29 March 2019.
Final Sale of Medicinal Products Following Approval of Variation to, Renewal and Transfer of Marketing Authorisation - 1%
10.12.2021 10:51:00With a view to frequent questions from marketing authorisation holders, SÚKL hereby provides more details on the final sale of medicinal products complying with the data and dossier valid prior to the implementation of a variation to marketing authorisation, prior to a marketing authorisation renewal or prior to the implementation of a marketing authorisation transfer. The information provided herein is applicable to medicinal products authorised via national procedures as well as MRP/DCP.
Field Safety Corrective Actions in 2015 - 1%
15.01.2015 15:40:34Field 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).
IMP with GMO for the treatment of COVID in CT 12.11.2020 - 1%
13.11.2020 09:49:00Information on documentation to be submitted for clinical trials on medicinal products for the treatment of COVID-19, 7.11.2020, updated 12.11.2020
Field Safety Corrective Actions in 2014 - 1%
7.01.2014 10:39:44Field 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).
May foodstuffs intended for particular nutritional uses contain also substances which are not listed in Annex 13 to Decree No 54/2004 Coll.? - 1%
16.04.2010 14:23:09Yes, but the assessment and authorisation of foodstuffs intended for particular nutritional uses is not within the powers of SÚKL and it is necessary to contact the Ministry of Health of the Czech Republic, department of Public Health Protection.
Most Frequent Deficiencies in Submission of Applications for Marketing Authorisation of Medicinal Products - 1%
4.02.2022 06:00:00SÚKL hereby notifies applicants for marketing authorisation that the marketing authorisation application dossier should contain data concerning only the strengths and pharmaceutical forms of medicinal products that are the subject of the respective applications and, furthermore, notifies about other frequent validation mistakes of marketing authorisation applicants.
Surveillance in the area of advertising - 1%
19.11.2007 09:15:04The 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).
Legislation of the Czech Republic - 1%
13.12.2007 12:26:35Acts and their implementing regulations governing the powers of SÚKL.
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