The MHRA GDP Symposium heralds the end of the year and the opportunity to mull over any advice on Regulatory changes and Inspectorate trends. The chance for clarity and what will be expected for (very) near future changes to trading laws and status –  especially this year, with the prospect of FMD and Brexit hanging over the whole proceedings.

There were, of course, plenty of other topics to deal with. Changes within the Inspectorate and Preparing for a potential changing world to begin with. The GDP Inspectorate are split into 3 main Operational groups and some details of these groups were presented. Currently there are 14 GDP Inspectors, with 2 leaving within the last year to go into Industry. The MHRA are still looking to recruit for at least one more GDP Inspector. The costs of Inspections will change, with those that are subject to Inspectorate Action Group (IAG) consideration being increased in price. It is intended that more desk-based inspections will be carried out for lower risk cases, and therefore reducing the costs of related inspections. More details can be obtained in another PCL log specifically on Inspection costs.

A Changing World. It was re-iterated that we are facing a very changeable social and political climate, so therefore there will be a changeable Business climate, and in turn changeable expectations with GDP compliance. Sourcing from and supplying to the EEA will require additional knowledge and experience. Goods sourced from (other) 3rd Countries and received through a supply route that includes mainland Europe could well be classified as “Introduced” products by these countries – meaning that a QP release will be required for its release in the UK.

To aid the potential minefields of importing and exporting (and Introduction), a new role will be created and recognised – The Responsible Person Import (RP-I). Full definitions of this role are still a little unclear, but we were told that they would be expected to be Qualified, Experienced, A member of a recognised body and an Eligibility Register and should provide evidence of EEA QP Batch Certification. A vital role, by the looks of it – of which we await further details. The intricacies of Customs Documentation and practices are to be considered as well.

Change Management featured prominently – the need for assessing each component and the inherent risks of a change in processes, and the effective review of mitigating measures. A case study of Great Northern Rail’s (GNR) changes to their time-table was presented, and how this had a negative and damaging impact on service. We moved on to the cost(s) of non-compliance. The very reasonable point was put forward that the cost of an effective, bespoke and relevant Quality Management System (QMS) will work out the same as an ineffective one. It will always be worth ensuring, through research and professional experience and advice, that the QMS is specific to an Organisation’s business model and intentions.

Trends and latest news on Enforcement investigations were presented. This included an update on “Z drugs” – which seem to be reducing in their overall activity. The number of investigations on rogue pharmacies seem to be increasing but the number of GPHC licence revocations (8) and MHRA successful convictions (2) still appear surprisingly low.

To the main topics of Brexit and FMD. Brexit is, as at the time of writing, at a point where nobody is sure what it will look like, The MHRA Inspectors know as little about this as the rest of us. Advice, I’m sure, will be available on Importing/Exporting and where Marketing Authorisations will now be required. There will be, it is presumed, a transition period (between March 2019 – December 2020) to inform on any trading with Europe and on the appointment of an RP-I (as mentioned above). Please note – this is quite possible a new level of consultancy. Overall, not much more can be advised at this stage.

ON FMD, it seems the same – “Not much is clear”. The confirmation that Manufacturers have not considered downstream Wholesale activities aside, the questions on the operational practicalities remain. For example, it was repeatedly mentioned that, where it is necessary (and that much also remains unclear) each packet will need to be scanned as verified. However, previous advice is that this can be undertaken on a “Risk Based Approach” basis. Who is responsible for verifying and decommissioning if you never physically handle the stock? Is it acceptable to outline this in a Technical Agreement? These, among other questions, are being interpreted in different ways but at PCL we will continue to find out and provide definitive answers and solutions.