Friday, 5 April 2013

Which licenses qualify for the pracitical experience?


As this post explained, the requirement to become eligible to be named as a QP is dependant on a number of conditions.  One of which is the 'practical experience' of 2 years within an authorised manufacturer of medicinal products. 

What does 'authorised manufacturer' actually mean?

Within the UK the following manufacturing licenses qualify for 'authorised manufacturer':
  • MIA
  • MIA(IMP)
  • ManA (veterinary products)
Other manufacturing licenses covering specials or unlicensed medicines such as MS, MeAT licences do not qualifiy.  Licences for wholesale dealing such as WL, WDL & WDA do not qualify either.

For those aspiring QPs from the NHS sector (like myself) you will need to have a MIA(IMP) license - the specials license that many NHS hospitals hold will not enable you to apply for QP eligibility.

Interestingly, there is no requirement for the license to be active within the 'practical experience' requirements of 2001/83/EC.  Therefore within your 2 year experience you may not actually witness a single batch being certified!  However, I would certainly not recommend this.  If your license is relatively inactive then you need to be going to industrial visits to shadow QPs during batch disposition.  I'll aim to cover a separate post on arranging industry visits as part of your QP training.

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