NLClinicalTrialsIMP object

Applicable national regulations

Transposition of (CT) Directive 2001/20/EC
Other

Transposition of (CT) Directive 2001/20/EC (or comparable national legal framework)

Legislative Decree n. 211 of 24 June 2003 / Decreto legislativo n. 211. Available in Italian and English (unofficial translation)

Other applicable regulations/ implementing provisions (Acts, laws, decrees, ordinances, circulars, etc)

(1) Decreto Ministeriale 21 Dec 2007 (it)/ Ministerial Decree 21 December 2007 (en_non official translate): As stated in Article 3 of this Decree, the local CA (section 1) may, completely or partially, appoint the EC concerned to the assessment of documentation as of attachment 1 to this decree; anyway, the application form, properly filled in compliance with appendix 5 to this decree, must be always forwarded to the Competent Authority.

(2) Decreto Ministeriale 12 Maggio 2006/ Ministerial Decree 12 May 2006 (only available in Italian): This decree regulates the responsibility and role of the independent ECs.

Additional Information

ad: Legislative decree 211/2003: The Decree issues additional provisions in order to better regulate the responsibility and the role of the ECs and to give instructions a.and to give instructions about the type of information to be submitted through the national database.

This project (ECRIN Integrating Activity/ECRIN-IA) has received funding from the European Union’s Seventh Framework Programme for research, technological development and demonstration under grant agreement no 284395
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