Rather than having to repeat the checks carried out by the EU QP, which would be bureaucratic and unnecessary, the MHRA created the role of Responsible Person (import) RPi, which enables UK companies to accept EU/EEA QP certification and to import and release under a Wholesale Distribution Authorisation (WDA).
We decided to kick off the New Year by talking to Nim Tarry our Associate Director, Consultant Responsible Person/Responsible Person for Import and our latest hire about the role of RPi and what it entails!
Hi Nim, so how did we end up in a situation where the UK has this different system? Why are there now two paths to approve using either a QP or an RPi?
Hi Charley, essentially due to Brexit (the UK chose to exit the European Union (EU) by vote) when the UK became a third country, the need for the RPi arose in the UK and this was defined by the MHRA via guidelines including The Human Medicines Act 2012. The QP is still very much needed to release batches that have not been manufactured or tested in the UK/ EU. However the RPi will release batches received from a country on the approved countries list which have EU QP certification providing all RPI checks are complete.
The RPi performs a release of product that is imported in to the UK, under a companies WDA(h) from countries on the approved list. The RPi ensures that QP certification is complete and in order, alongside ensuring all temperature data is available and within specification The RP cannot legally do this.
The RP is however needed for products sourced from NI for wholesale purposes. Products manufactured and released in the UK that are supplied under the WDA(h).
How did you end up becoming an RPi and what should the readers of this article know before considering training for this role?
Having worked in industry and being on a WDA(h) licence for some years, I felt that this was an area I would like to develop in to and work in. There are pre-requirements that an individual must fulfil prior to being added to the WDA(h) as an RPi, these are defined in a guidance document as follows https://www.gov.uk/guidance/acting-as-a-responsible-person-import. This document goes in to detail regarding experience needed, qualifications, professional bodies and eligibility and suitability.
What does a typical day look like for an RPi?
No day is the same, there are times when I will perform RP duties, as you mentioned Charley I am an RP and RPi and other times when a delivery requires RPi release all the required checks are completed. Some days there are a number of deliveries other there aren’t so many. But in between the deliveries there is the management of the QMS, ensuring training is up to date. All individuals working on GDP matters are adequately GDP trained. The management of any outsourced providers such as 3PLs, this all lies with the RPi also. Ensuring regular quality meetings are held to discuss new suppliers and customers. Occasionally there may be issues which require non-conformances, or complaints, or returns all of which need input from the RP/RPi.
I think the biggest thing was the flexibility it gives the client and also myself, and it was so interesting to see the various stages that each client was at in the process. There are clients that are at the initials stages of needing to submit an application and then there are clients that are fully established needing on-going support.
Also, when you are working full time with one company you don’t see all the other ways of working and the stages that companies may be at. As you are only on that companies journey.
I now have clients at all stages of the process and it makes it very interesting no client is the same. Each requires my support in different ways.
Depending on the business model and the expected volume of deliveries it may be necessary to have an individual full time. However if this isn’t the case the company will be paying for an RP/RPi that is not fully utilised and it may be more cost effective to use a consultant.
A consultant will also have the experience having worked with a number of companies, I feel this gives the consultant RPi/RP a wider breadth of knowledge that can be applied.
The downside is there will be days the consultant may not be available when the client may wish, however depending on the nature of the issue this could be worked around.
Thank you so much, Nim, for giving us your insights and for all the hard work you do for our clients!
If you wish to avail of our services and are interested in the leanest path to getting pharma products into and onto the UK market, please email us at charley@oriongxp.com or call the office at +44 (0)203 4750375.