NLClinicalTrialsIMP object

EU Directives have been transposed into the Irish Statute Book as the European Communities (Clinical Trials on Medicinal Products for Human Use) Regulations 2004 to 2009, comprised of:
- The European Communities (Clinical Trials on Medicinal Products for Human Use) Regulations 2004 to 2009, transposing (A) the EU Directive (S.I No. 190 of 2004), (B) the GCP Directive (S.I No. 374 of 2006) and (C) giving effect to the ATMP Regulation (S.I No. 1 of 2009).
- And, Regulation 16(2) of the Medicinal Products (Control of Manufacture) Regulations 2007 ( S.I. No. 539 of 2007),
- And, Regulation 27 of the Medicinal Products (Control of Placing on the Market) Regulations 2007 (S.I No. 540 of 2007).

Yes

Incorporated in transposition act(s) of Directive 2001/20/EC

Clinical trials are governed by EU Directives, including the Clinical Trial and GCP Directive, and associated guidance including in particular, the International Conference on Harmonisation Guidance and Eudralex, Volume 10 Notice to Applicants.