Search form
Search results
Search for: St%C3%A1tn%C3%AD %C3%BAstav pro kontrolu l%C3%A9%C4%8Div %28S%C3%9AKL%29 uv%C3%A1d%C3%AD na pravou m%C3%ADru myln%C3%A9 a zav%C3%A1d%C4%9Bj%C3%ADc%C3%AD informace%2C kter%C3%A9 uvedla v %C4%8Dl%C3%A1nku %E2%80%9EKmenov%C3%A9 bu%C5%88ky pro diabetiky%3A propl%C3%A1cen%C3%AD se odkl%C3%A1d%C3%A1%E2%80%9C redaktorka Lenka Petr%C3%A1%C5%A1ov%C3%A1.
SÚKL information – form updates - 1%
27.05.2008 12:38:54The 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.
List of reimbursed medicinal products valid as of 1.1.2022 - 1%
31.12.2021 12:14:21Státní 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").
Administrative Procedure Regarding Permission of Distribution, Dispensing, Placement on the market or Use of a Medicinal Product - 1%
3.08.2021 09:44:13General information and requirements for the possibility to initiate an administrative procedure regarding permission to distribute, dispense, place on the market, or use of a medicinal product in compliance with Section 13(2)(m) and Section 23(2)(b) of the Act on Pharmaceuticals, as amended.
Information for MAHs and CT sponsors on EV and SÚKL downtime and the transition to centralised ADR reporting - 1%
16.10.2017 14:42:00MAHs 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)
Field Safety Corrective Actions in 2013 - 1%
3.01.2013 08:46:11Field 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 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 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).
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).
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).
Publication activities - 1%
19.11.2007 10:22:43SÚKL 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).
DCP Slots Allocation with SÚKL as the RMS - 1%
4.12.2017 13:52:23SÚKL 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.
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
Amendment to the reimbursement decree – payments for marketing authorisation variations effective as of 15 October 2013 - 1%
11.10.2013 10:57:00On 15 October 2013, the amendment to decree no. 427/2008 Coll., on determination of the amount of costs to be reimbursed for specialised tasks performed by the State Institute for Drug Control and the Institute for State Control of Veterinary Biologicals and Medicines (the “reimbursement decree”), has come into effect.
cz