News

• 01/10/2020
  SK as RMS
• 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 Council Regulation (EC) No 111/2005 laying down rules for the monitoring of trade between the Union and third countries in drug precursors, and repealing Commision Regulation (EC) No 1277/2005
• 08/12/2016
  Slovak human and veterinary medicines agencies hosted the second meeting of the Heads of Medicines Agencies
• 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
• 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
  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
• 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 variations in marketing authorisation and registration dossier