About SIDC
- Quality Policy
- Leadership of SIDC
- Mission
- Organigramme
- Advisory Bodies
- Committee for Medicinal Products
- Subcommitee for Generic Medicines
- Subcommittee for Phytotherapeutics and Homeopathics
- Committee for Drug Safety
- Pharmacopoeia Committee
- Annual Reports
- Annual Report 2016
- Annual Report 2015
- Key Performace Indicators in 2014
- Key Performace Indicators in 2013
- Key Performace Indicators in 2012
- Key Performace Indicators in 2011
- Key Performace Indicators in 2010
- Annual Report 2009
- Annual report 2008
- Annual report 2007
- Annual report 2006
- Annual report 2005
- Annual report 2004
- Annual report 2003
- Links
Registration of Medicinal Product
- Scope of activities
- Instructions
- Submission of the marketing authorisation application via DCP, MRP
- Submission of the marketing authorisation application via national procedure
- SIDC as RMS
- Sunset clause
- Announcement of a maintenance of the information system of SIDC
- Notification about the possibility to submit authorisation applications and related documents through the CESP Portal
- Submission of ASMF to SIDC
- Electronic Application Forms (eAFs) mandatory for all precedures from January 2016
- State Institute for Drug Control have joined the CESP system for a pilot phase
- Fees for drug registrations connected to the amendment of the Act on Administrative fees
- Changes in the registration processes connected to the amendment of the Act on Administrative Fees
- Submission of registration documentation concerning the new Marketing Authorisation Applications in the eCTD format from 1. June 2012
- Electronically submitted applications regarding marketing authorisation in Slovak Republic - Information on status and national requirements
- Withdrawal of the marketing authorization only for the certain strength of the product
- PROCESSING OF ELECTRONIC SUBMISSION ECTD – ONGOING ISSUES
- Submission of an application for a marketing authorization, variation or renewal on electronic media (CDs)
- Announcement for applicants/marketing authorization holders - procedure in relation to Commisiion Regulation (EC) No. 1234/2008 concerning the variation to the terms of MA
- SIDC as RMS for 2011
- Phase I: eApplication submission launch September 7th, 2009
- Phase I: eApplication submission planned launch from September 7, 2009
- Annex No. 23 to the marketing authorization application
- SIDC Guidance on the Processing of Type IA and IB Notifications
- Scientific Advice
- Contact
- Forms
Laboratory Control
- Scope of activities
- Instructions
- Administrative batch release of vaccines and medicinal products derived from human blood or plasma
- Internationally Harmonized Requirements for Batch Certification
- Contact
Inspection
- Scope of activities
- Instructions
- Drug manufacture
- Pharmacy
- Distribution
- Transfusiology
- Post-authorisation quality control
- Export of medicinal products
- Introducing, suspensions and cancellations of supplies of medicinal products in Slovak Republic
- Contact
Drug Precursors
- Scope of activities
- Legislation on Drug Precursors
- 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
- COMMISSION DELEGATED REGULATION (EU)
- Corrigendum to the Commission Delegated Regulation (EU) 2015/1011 of 24 April 2015 supplementing Regulation (EC) of the European Parliament and of the Council on drug precursors
- COUNCIL REGULATION (EC) No 111/2005 of 22 December 2004 laying down rules for the monitoring of trade between the M1 Union and third countries in drug precursors
- REGULATION (EC) No 273/2004 OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL of 11 February 2004 on drug precursors
- COMMISSION IMPLEMENTING REGULATION (EU) 2015/1013 of 25 June 2015 laying down rules in respect of Regulation (EC) No 273/2004 of the European Parliament and of the Council on drug precursors and of Council Regulation (EC) No 111/2005 (drug precursors)
- COMMISSION DELEGATED REGULATION (EU) 2015/1011 of 24 April 2015 supplementing Regulation (EC) No 273/2004 of the European Parliament and of the Council on drug precursors and Council Regulation (EC) No 111/2005 (drug precursors)
- COMMISSION REGULATION (EC) No 1277/2005 of 27 July 2005 laying down implementing rules for Regulation (EC) No 273/2004 of the European Parliament and of the Council on drug precursors
- COMMISSION REGULATION (EC) No 297/2009 amending Regulation (EC) No 1277/2005
- COMMISSION REGULATION (EU) No 225/2011 of 7 March 2011 amending Commission Regulation (EC) No 1277/2005 (drug precursors)
- № 331 ACT of 23 June 2005 on state administration authorities in matters of drug precursors, and on amendments and additions to some laws
- REGULATION (EU) No 1258/2013 OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL of 20 November 2013 amending Regulation (EC) No 273/2004 on drug precursors
- REGULATION (EU) No 1259/2013 OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL of 20 November 2013 amending Council Regulation (EC) No 111/2005 laying down rules for the monitoring of trade between the Community and third countries in drug precursors
- Contact
Pharmacovigilance
- Scope of activities
- Instructions
- New or changed procedures related to the new pharmacovigilance legislation in transitional period
- Reporting requirements of ICSR
- Form for Details of MaH or Sponson for electronic reporting of ICSR
- Contact
Clinical Trials
Pharmacopoeia
Medical Devices
- Scope of activities
- News
- Instructions
- List of registered / announced medical devices, codes and economic operators from 1.3.2018
- Contact
- Links
Media
- News
- Slovak human and veterinary medicines agencies hosted the second meeting of the Heads of Medicines Agencies
- In October, the SIDC presidency meetings focused on medical devices issues and public relations
- The Heads of Medicines Agencies was held in Bratislava
- European Commission launches a new mandatory logo for online sale of medicines to protect patients from falsified medicines
- Contact
Databases and Services
Contact
