Call QPQuandary on: 07813 677741

UPDATE Transitional IMP QP – Important News

Updated Guest post by Kastur Patel – Transitional IMP QP

Many of you reading this will be aware that the new Clinical Trial Regulation No 536/2014 does not allow for transitional QPs.

There are 2 types of transitional QPs, those who were ‘grandfathered’ in the 1970’s and those (like me) who became transitional IMP QPs between 2004 and 2006, under Directive 2001/20/EC.

Latest news from the MHRA is that the ‘grandfathered QPs’ will not be affected, possibly because there will be very few still in service.

There are, however, many transitional IMP QPs working in the CRO and NHS sectors.  As there is not a public register available for this (the MHRA do have a register, apparently), I cannot give you any numbers, but I know a fair few.

IMP QPs will need to be ‘re-qualified’ and the process will be similar to when a QP moves from one licence to another.  The MHRA are working on a form [similar to the form that currently needs to completed in order to be named on an MIA or MIA(IMP)].  This form will be available sometime in April.

The form for assessment by the MHRA is now available on their website here.  You will need to scroll down quite a bit to find it.  You will need to submit a copy of your CV and “brief details of qualification, training and continued professional development … plus work experience … relevant to IMPs completed since your initial transitional QP assessment”  The MHRA also require brief details of licence number(s) of site(s) you have worked at.

Each transitional IMP QP will be required to complete this form, be assessed for suitability to remain on the licence. There will be no charge for this, but what is unclear is whether the MIA(IMP) will need to be updated (and therefore incur a cost), especially if some IMP QPs are no longer deemed ‘suitably qualified’.

There does not appear to be any requirement for a license update providing the QP is considered acceptable, I would imagine that any questions will be dealt with on a case by case basis.

The nomenclature will not change, and we will still be ‘transitional IMP QPs’, and the MHRA will look into whether this register should be publicly available.

Something else that may interest pharmacist QPs reading this, if you are working in the pharmaceutical of CRO sectors, and have no intention of working as a pharmacist, then you do not need to be registered with the GPhC.  You should be a member of the RPS to maintain your eligibility as a QP, or you could register with the RSC or RSB and save yourselves some money.  Of course, if you want to continue to do community locums, or work in hospital then you do have to keep up your registration.

I hope you found this useful and would be happy to hear your thoughts.  Please contact me via the Alex using the contact page of this website or via the QPQuandary Facebook or Twitter accounts.

Latest QP Question

What are the requirements for unlicensed medicinal products in the UK, do you need QP certification? Where would you find guidance?

Latest QP Scenario Practice

Iron Oxide - used as an excipient in many of your products. You find that the supplier has been irradiating the material without your knowledge. What implication does this have for your product? What does this mean for the effectiveness of your supplier oversight and PQS?


"The knowledge, guidance and advice provided by Alex was excellent. Alex has first hand knowledge of the requirements needed for candidates to be successful QPs and provides a level of training to meet these requirements. I can highly recommend QPQuandry as a service provider"
Alex Hern, Sanofi.


Contact Information

20 Playfield Close, Biggleswade, Bedfordshire, SG18 8JL
Phone: 07813 677741
Website: http://www.qpquandary.co.uk
Email: alex@qpquandary.com"