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Transitional QPs for Investigational Medicinal Products (IMPs) - Update

Posted by: , Posted on: - Categories: Compliance matters, Good clinical practice, Good manufacturing practice

We are aware there is some concern for UK business and personal careers, over the status of transitional QPs that were recognised under the transitional arrangements provided in SI 2004/1031, when the Clinical Trials Directive was implemented in 2004. The background to this and plans on how we intended to address the situation in the UK were outlined in my earlier blog on this topic.

The purpose of this blog is to confirm that the GMDP Inspectorate has now launched the reassessment process to give transitional QPs for IMP the opportunity to demonstrate how they now meet Article 49(2) & (3) of Directive 2001/83/EC, in line with the requirements of EU Regulation 536/2014.

Further information about the reassessment process is available on the MHRA website. There is no charge for the application and completed forms should be emailed to for assessment. Following assessment, eligibility certificates will be issued to those meeting the requirements set out in set out in Article 49(2) and (3) of Directive 2001/83/EC.

The reassessment process only applies to applicants who were assessed and acknowledged as transitional QPs under the SI 2004/1031 arrangements, which means transitional QPs that have been named as a QP in a valid application for a manufacturing authorisation for IMPs made prior to 1st May 2006 under the Medicines for Human Use (Clinical Trials) Regulations 2004 (SI 2004/1031).

This scheme is not open to any new trainee QPs wanting to specialise in the IMP sector, who would need to apply for eligibility assessment through the Joint Professional Bodies category A assessment route.

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