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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.
The recommended procedures – update 12.2.2020 - 1%
13.02.2020 11:19:19The 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)
The recommended procedures - 1%
4.01.2018 15:13:57The 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).
Q&A for labelling - 1%
24.09.2021 08:57:59The requirements for labelling of Investigational medicinal products are given in European Commission guideline: The Rules Governing Medicinal Products in the European Union, Volume 4, EU Guidelines to Good Manufacturing Practice, Annex 13, Investigational Medicinal Products. This guideline is translated to the Czech and listed as VYR-32 Appendix 13.
Pharmacopoeial publications - 1%
22.11.2007 13:35:21A 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.
Update of requirements for Marketing Authorisation Holders to Evaluate the Risk of the Presence of Nitrosamines - 1%
6.04.2020 13:04:14In compliance with the procedure outlined under Art. 5(3) of Regulation (EC) no. 726/2004, holders of marketing authorisations of human medicinal products containing chemically synthesised active substances and biological active substances are hereby invited to review the manufacture of their medicinal products in view of potential presence of nitrosamines. The updated conclusions dated 18.2.2021 can be found on the EMA website.
Notification of launch, suspension, renewal or withdrawal from the market of a medicinal product - 1%
29.10.2009 10:00:06A marketing authorisation holder has a statutory duty to report the placement of a medicinal product onto the market in the Czech Republic and its suspended or terminated and subsequently resumed marketing.
KLH-EC-01 - 1%
25.06.2009 11:18:18Application for Ethics Committee Opinion on the Conduct of a Clinical Trial in the Czech Republic – requirements governing the documentation to be submitted
Update of the PHV-4 Guideline - 1%
21.12.2016 08:15:12Information on SUKL’s update of the PHV-4 Guideline
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