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Thread: Amendment 60 to 2001/20/E

  1. #1

    Amendment 60 to 2001/20/E

    The proposed amendment 60 to the Clinical Trials Directive2001/20/E (proposal for a Regulation Article 55 - subparagraph 1) is to archive the TMF indefinitely.

    If this comes into force, when will it be implemented?

  2. #2
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    Nov 2011
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    Difficult to say as the Amendments published so far have already proposed both 15 and 20 Year periods. In fact, if the EU was to be consistent, then in compliance with 2003/63/EC for studies that result in a product license applications, many clinical records should be held for either ICH GCP criteria or 15 years (the choice seems to be the applicants). As there may be many amendments before it becomes EU law, it is difficult to say when it will come into force. The proposed Regulation does allow a period of time to implement the new Regulation and for quite a while, studies conducted under 2001/20/EC can continue to be compliant with that.

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