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There were 89 items found in the Articles section.
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Information for MAHs and CT sponsors on EV and SÚKL downtime and the transition to centralised ADR reporting - 4%

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)

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? - 4%

5.04.2013 14:34:18 Veronika Petláková

Appointment of the contact person for PV issues in the CZ who will be subordinated to the QPPV in accordance with Section 91a, Sub-section 3. Is the appointment of the contact person for PV issues required in the CZ? - 4%

5.04.2013 14:36:14 Veronika Petláková

Guidelines and Forms - 4%

19.01.2008 12:27:08 Veronika Petláková

Foreign Institutions - 4%

3.12.2007 11:25:59

Foreign Societies, Associations - 4%

3.12.2007 11:26:53

Guidelines EMA, EC, CMD and HMA - 4%

18.12.2007 13:08:25

Message to sponsors transitioning trials to CTR/CTIS - 4%

4.12.2023 15:49:04 Hana Hábová

Notice to applicants for placing of foreign language batch of a medicinal product on the market - 4%

30.10.2018 08:44:00 Antonín Faukner
Notice to applicants on requirements to permit the placing of foreign language batch of a medicinal product on the market in the Czech Republic.  
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