Despite the MHRA’s guidance note 6 there is a lack of a clearly defined and standardised route into becoming a trained, experienced, and effective Responsible Person (RP), and consequently the MHRA are now placing a greater emphasis on the suitability of a licence holder’s RP, perhaps in an attempt to ensure that all roads eventually lead to the same destination or to gradually develop and define the necessary route, or maybe both.  Regardless of the aim the MHRA has stated the suitability of a licence holder’s RP will be under more scrutiny than before, along with focusing on the licence holder’s responsibility in ensuring their RP is equipped with sufficient knowledge and experience to function effectively in their role within the organisation and fulfil their responsibilities.

In a recent MHRA blog, the MHRA have listed and addressed a number of key areas that they view as being important in making a good RP which makes it a ‘must read’ for every RP if the required standard is to be demonstrated and evidenced during future inspections.

One of the ‘stand-out’ key factors discussed was in the uptake of good quality external training by the RP and the MHRA clearly placed an onus on the licence holder too by stating that every licence holder should consider providing this for their RP and if not, at least be in a position to justify not providing the training.

Whilst the increased attention could possibly be interpreted as bad news for RPs and licence holders alike, the good news is that the MHRA’s overall effect should be to push up standards, improve compliance, and in so doing provide greater assurance in terms of the safety, quality and efficacy of medicinal products through ‘making’ the RP good.