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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.

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There were approximately 958 items found in the Articles section.

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List of reimbursed medicinal products valid as of 1.1.2022 - 3%

31.12.2021 12:14:21 PharmDr. Kamil Kalousek
Státní ústav pro kontrolu léčiv v souladu s § 39n odst. 1 zákona č. 48/1997 Sb. o veřejném zdravotním pojištění v platném znění (dále jen "zákon") zveřejňuje Seznam cen a úhrad léčivých přípravků a potravin pro zvláštní lékařské účely (dále jen "Seznam").

DCP Slots Allocation with SÚKL as the RMS - 1%

4.12.2017 13:52:23 Bc. Lucie Mrázková
SÚKL informs about a system of slots allocation within the scope of decentralised procedures (DCP) with SÚKL as the Reference Member State (RMS), effective as of 1 January 2018. DCP slots are allocated on a continuous basis for each half of a month.

New Method of SÚKL Code Notification for Centrally Authorised Medicinal Products - 1%

19.09.2018 09:13:54 Petra Špimrová
SÚKL hereby informs about a new method of SÚKL code notification, i.e. a change in the issuance of identification sheets for centrally authorised medicinal products as of 1 October 2018.

Information for MAHs and CT sponsors on EV and SÚKL downtime and the transition to centralised ADR reporting - 1%

16.10.2017 14:42:00 Lucie Šustková
MAHs and CT sponsors are informed that due to the transition to new EudraVigilance system SÚKL will stop receiving electronic ADR reports (ICSRs, SUSARs) from MAHs and CT sponsors as of 7 November 2017 (00.00 a.m. CET)

Publication activities - 1%

19.11.2007 10:22:43 vrana
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).

KLH-20 version 6 - 1%

7.01.2021 10:51:58 Pavel Trnka
This guideline supersedes guideline KLH-20 version 5 as of 10 April 2020.

Information for marketing authorisation holders concerning ways of introducing blue-box information on medicinal product labelling - 1%

10.06.2021 14:54:59 Bc. Lucie Mrázková
SÚKL hereby informs marketing authorisation holders about an update to the guidance laying down blue-box requirements for medicinal product labelling.

Czech State Institutions - 1%

3.12.2007 11:14:14

Pursuant to Act No 378/2007 Coll., on Pharmaceuticals and on Amendments to Some Related Acts (Act on Pharmaceuticals) - 1%

20.12.2007 14:04:35

Data mailbox information system - 1%

2.07.2009 12:46:43
Information on SÚKL's data mailbox communication.

Information for marketing authorisation holders concerning the declaration of general classification for supply on medicinal product labelling - 1%

10.06.2021 15:07:59 Bc. Lucie Mrázková
SÚKL hereby informs marketing authorisation holders on possible ways of showing the general classification for supply on medicinal product labelling.

Information from SÚKL - 1%

5.08.2008 08:50:30 Veronika Petláková
New the website contains a list of approved clinical trials.

Documentation to be submitted by the applicant for SÚKL opinion - 1%

26.11.2021 09:31:04 Veronika Petláková
The State institute for Drug Control publishes more detail information to the submitted documentation for applicants of Specific Therapeutic Programme (hereinafter “STP”).

Requirement for a MAH to be obliged to immediately provide information about changes in the PSMF in accordance with Section 91, Sub-section 2, Letter b). Does this mean that each change in the PSMF must be reported to SÚKL? - 1%

5.04.2013 14:34:18 Veronika Petláková

Reporting changes in contact details - 1%

19.11.2007 10:32:00 vrana
Details of reporting requirements regarding all changes in contact information.

SÚKL information – form updates - 1%

27.05.2008 12:38:54 Veronika Petláková
The State Institute for Drug Control hereby informs about the updates to interactive forms to be conducted on May 30 2008 from 8:00 a.m. to 5:00 p.m., which will require an outage.

SÚKL´s opinion on the inclusion of Ukrainian patients in clinical trials in the Czech Republic - 1%

10.03.2022 08:34:50 Iva Jelínková

Contacts - 1%

12.12.2007 14:22:33

Contacts - 1%

14.12.2007 09:18:03

Mandatory payment of annual maintenance fees - 1%

2.10.2015 15:28:32 Bc. Lucie Mrázková
SÚKL informs marketing authorisation holders about their obligation to reimburse compensation of costs for SÚKL activities associated with the maintenance of medicinal product marketing authorisations by means of annual maintenance fees.