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News

25/09/2017

Submission of the marketing authorisation application via DCP, MRP

25/09/2017

Submission of the marketing authorisation application via national procedure

23/05/2017

Corrigendum to Commision Delegated Regulation (EU) 2015/1011 of 24 April 2015 supplementig Regulation (EC) No 273/2004 of the European Parliament and of the Coucil on drug precursors and Coun

08/12/2016

Slovak human and veterinary medicines agencies hosted the second meeting of the Heads of Medicines Agencies

10/11/2016

SIDC as RMS

09/11/2016

In October, the SIDC presidency meetings focused on medical devices issues and public relations

23/09/2016

Announcement of a maintenance of the information system of SIDC

12/09/2016

The Heads of Medicines Agencies was held in Bratislava

01/08/2016

Notification about the possibility to submit authorisation applications and related documents through the CESP Portal

06/04/2016

Submission of ASMF to SIDC

13/10/2015

European Commission launches a new mandatory logo for online sale of medicines to protect patients from falsified medicines

02/10/2015

State Institute for Drug Control have joined the CESP system for a pilot phase

18/06/2015

[C]COMMISSION REGULATION (EU) No 225/2011 of 7 March 2011 amending Commission Regulation (EC) No 1277/2005 (drug precursors)

01/10/2012

Fees for drug registrations connected to the amendment of the Act on Administrative fees

17/09/2012

Changes in the registration processes connected to the amendment of the Act on Administrative Fees

29/12/2011

Electronically submitted applications regarding marketing authorisation in Slovak Republic - Information on status and national requirements

10/11/2011

Clinical Trials Procedures

10/10/2011

Withdrawal of the marketing authorization only for the certain strength of the product

22/06/2011

PROCESSING OF ELECTRONIC SUBMISSION ECTD – ONGOING ISSUES

09/03/2011

COMMISSION REGULATION (EU) No 225/2011 of 7 March 2011 amending Commission Regulation (EC) No 1277/2005 (drug precursors)

03/02/2010

Announcement for applicants/marketing authorization holders - procedure in relation to Commisiion Regulation (EC) No. 1234/2008 concerning the variation to the terms of MA

27/01/2010

SIDC as RMS for 2011

04/09/2009

Phase I: eApplication submission launch September 7th, 2009

21/08/2009

Phase I: eApplication submission planned launch from September 7, 2009

10/06/2009

Annual report 2008

17/11/2008

Annex No. 23 to the marketing authorization application

24/04/2008

SIDC Guidance on the Processing of Type IA and IB Notifications

15/01/2008

Comments to Commision Regulation proposal concerning the examination of

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