Transcription of EXPLANATORY MEMORANDUM TO THE …
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EXPLANATORY MEMORANDUM TO THE MEDICINES FOR HUMAN USE (CLINICAL TRIALS) AMENDMENT REGULATIONS 2006 2006 No. 1928 1. This EXPLANATORY MEMORANDUM has been prepared by the Medicines and Healthcare products Regulatory Agency/Department of Health and is laid before Parliament by Command of Her Majesty. This MEMORANDUM contains information for the Joint Committee on Statutory Instruments. 2. Description These Regulations principally implement Commission Directive 2005/28/EC of 8 April 2005 laying down principles and detailed guidelines for good clinical practice as regards investigational medicinal products for human use, as well as the requirements for authorisation of the manufacturing or importation of such products (the GCP Directive) through amendment to the Medicines for Human Use (Clinical Trials) Regulations 2004 [ 2004/1031] (the Clinical Trials Regulations).
EXPLANATORY MEMORANDUM TO THE MEDICINES FOR HUMAN USE (CLINICAL TRIALS) AMENDMENT REGULATIONS 2006 2006 No. 1928 1. This explanatory memorandum has been prepared by the Medicines and
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