NLClinicalTrialsIMP object
Applicable national regulations
Transposition of (CT) Directive 2001/20/EC
Transposition of (GCP) Directive 2005/28/EC
Other
Transposition of (CT) Directive 2001/20/EC (or comparable national legal framework)
Act No. 378/2007 Coll., on Pharmaceuticals and on Amendments to Some Related Acts (Act on Pharmaceuticals), as amended.
Applicable to ATMP/ GMO trials
Yes
Transposition of (GCP) Directive 2005/28/EC
Incorporated in transposition act(s) of Directive 2001/20/EC
Other applicable regulations/ implementing provisions (Acts, laws, decrees, ordinances, circulars, etc)
- Decree No. 226/2008 Coll., on good clinical practice and detailed conditions of clinical trials on medicinal products (“Decree on GCP”): implementing provisions of Act on Pharmaceuticals (available in English)
- Decree No. 228/2008 Coll., on marketing authorisation of medicinal products
Additional Information
A complete list of implementing regulations and decrees is provided on the SÚKL website in "Legislation and guidelines".
