This year’s MHRA GDP Symposium seemed to focus on ‘contract’ RP’s with numerous references being made to them, and the services they offer, throughout the day.  The MHRA recommended that  prospective RP’s should be reference checked, prior to engagement, to ensure experience and knowledge appropriate to the licence holder’s business model.  Of notes is the MHRA’s reference to their preference for the appointment of RP’s trained to the Cogent Gold Standard.

It is interesting to note that the MHRA has plans in the pipe-line, in the case of a ‘no deal’ Brexit, for a new WDA with an MIA element. In order to meet the requirements of this authorisation, the licence holder will be required to either employ or retain the services of an RPI (Responsible Person for Import) who will be required to be registered with a professional body, such as the GpHC.

The question you may now be asking yourself is “Where will this leave RP’s who don’t fit into this category?”  That is unclear at the moment but it may be a good idea to consider undertaking a Cogent Gold Standard Training qualification in order to get ahead of the game.  Uncertain times ahead for RP’s it would seem.

On a different subject, the MHRA have made the point, at this year’s symposium, that concerns around bona-fide deficiencies have shifted from suppliers to customers.  The implication is that the MHRA are unhappy with the depth of due diligence checks that are currently being carried out.  With this in mind, it would be prudent to review your bona-fide checks process to ensure that it is fit for purpose.

On a final note, make sure to be vigilant with regard to transactions which may be suspicious i.e. unusual sales patterns.  Times are hard at the moment and the diversion of legitimate medicinal products is on the increase.

DT Burns