About SIDC
- Quality Policy
- Management
- Mission
- Co-operation International
- Quality Management
- Organigramme
- Advisory Bodies
- Committee for Medicinal Products
- Subcommittee for Phytotherapeutics and Homeopathics
- Committee for Drug Safety
- Assembly for Drug Quality
- Pharmacopoeia Committee
- Ethics Committee for Animal Testing
- Seminars & Presentations
- Annual Reports
Registration of Medicinal Product
- News
- Instructions
- Electronically submitted applications regarding marketing authorisation in Slovak Republic - Information on status and national requirements
- SIDC as RMS
- Withdrawal of the marketing authorization only for the certain strength of the product
- PROCESSING OF ELECTRONIC SUBMISSION ECTD – ONGOING ISSUES
- Additional requirements for submission of the MRP and DCP dossier in the Slovak republic
- 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
- Forms
- Scientific Advice
- Payment
- Contact
- Links
Quality Assessement of Medical Products
Inspection
Drug Precursors
- News
- COMMISSION REGULATION (EU) No 225/2011 of 7 March 2011 amending Commission Regulation (EC) No 1277/2005 (drug precursors)
- COMMISSION REGULATION (EC) No 297/2009 amending Regulation (EC) No 1277/2005
- Commission regulation (EC) No 1277/2005
- Council regulation (EC) No 111/2005
- Regulation (EC) No 273/2004 of the European parlament and of the council
- Contact
Drug Safety
Clinical Trials
- Procedure for Submitting of Clinical Trials Application
- News
- Instructions
- Duration of approval process
- Duration of approval process 2010
- Duration of approval proces 2009
- Duration of approval process in 2008
- Duration of approval process in 2007
- List of approved clinical trials in 2007
- Number of Clinical Trials in 2006
- List of approved Clinical Trials in 2006
- Duration of approval process in 2006
- Contact
- Links
Medical Devices
Media
Databases and Services
- Searching on the Database of Medicinal Products and Medical Devices
- Other lists
- List of registered Medicinal Products
- List of registered Medical Devices
- List of Medicine Manufacturing Authorization Holders
- List of medicines wholesalers
- List of pharmacies
- List of Authorised Laboratories
- Contact Form
- Sitemap
- A - Z index
- Abbreviations
- Links
- FAQ
Contact
