As we look to 2021 we are in uncharted territory as the UK leaves both the EU and the EMA. The UK will continue to be an important market to help pharmaceutical companies launch products and grow their business. There will be new opportunities such as the recent announcement that the MHRA will be joining the newly formed global country ACCESS Consortium.
The UK market in the next 12 months – a checklist for MAHs
There will also be risks to consider – companies should assess existing ways of working for UK licenses granted using European procedures in order to continue to operate effectively in the UK for their medicines portfolio. For pan European products authorised centrally, grandfathering should mean UK licences remain valid in the UK. However, each Marketing Authorisation Holder (MAH) has obligations to share data with the MHRA as they may not have access to all of the supporting data required to facilitate the grandfathering process. This is the first separation of its kind and the potential data volumes involved are huge, which creates both challenges and opportunities, and so we have considered some questions you might want to reflect on.
Q1. Are you withdrawing a product from the UK?
All centrally authorised EU products currently in the UK market will see their licences automatically grandfathered across to the MHRA post-Brexit on 1st January 2021. If you do not wish to hold a UK license then the MHRA will need to be notified to withdraw a product from the UK market, otherwise your licence will continue under grandfathering. Nationally granted UK licenses (including those from decentralised procedure (DCP) and mutual recognition procedure (MRP)) will continue to be valid after Brexit as the MHRA already holds a copy of the information in their systems.
If you intend to withdraw a product from the UK, we recommend you proactively give the MHRA notice well in advance.
Q2. Do you have products you want to continue to sell in the UK?
Nationally granted UK licenses (including those from DCP/MRP procedures) will continue to be valid after Brexit as the MHRA already holds a copy of the information in their systems. Centrally authorised European products currently in the UK market will see their licences automatically grandfathered across to MHRA. The MHRA does not currently hold the data for these licenses in its systems and companies will need to supply a ‘baseline sequence’ as a foundation for future lifecycle activities.
In our view companies should contact the MHRA in Q1 2021, or earlier, if they hold centrally granted EU licenses. It is prudent to send the latest data sequences behind each current licence (even if there are no plans at the moment for variations or extensions) to ensure they are ready for any unexpected changes to their licenses. For national applications it is important to check the lifecycle status and future ways of working with a suitable expert publishing team for submissions going forward. For all licenses it is important to ensure relevant UK contact points are considered if there is no UK local company established.
Q3. What happens if I have a planned UK launch that will be ‘in flight’ on 1 January 2021?
Those with products that are in the process of being assessed, termed ‘in flight’, would be well advised to seek specialist advice as there are both known and emerging grey areas here that are situation specific.
Check with regulatory experts who know the UK well, so you can ascertain issues and devise a plan for each product currently ‘in flight’.
Q4. Have you checked you will still have an acceptable MAH for the UK?
A consequence of the MHRA becoming a fully sovereign regulator is that post September 2023 a holding entity can no longer be based outside the UK. Each authorisation must be held by an acceptable UK-based entity or other pre-agreed point of contact (such as Diamond Pharma Services).
If your holding entity is currently based outside of the UK, it would be prudent to check with suitable UK regulatory experts that your planned new UK holding arrangement will be acceptable.
Q5. Have you thought through your pharmacovigilance responsibilities after Brexit?
Drug safety is an essential part of all medicines. After the UK leaves Europe on 1st January companies will have up to 12 months to appoint a local UK contact person if their Drug Safety Team is based in Europe rather than in the UK.
After Brexit, clearly report your UK drug safety responsibility plans to the MHRA.
Q6. What about future variations or extensions ?
The UK will continue to follow European ways of working for post-approval lifecycle changes in the main, with some subtle differences that will require input from UK regulatory experts prior to submission.
If you are planning to apply for a licence extension or approval of a variation, we do strongly recommend proactive submission of the baseline data sequence for centralised products, not simply assuming grandfathering of the current licence and access to its supporting data will proceed fully and perfectly. For national applications it is important to check the lifecycle status and future ways of working with a suitable expert publishing team.. Diamond Pharma Services can help companies navigate these changes.
We believe UK variation and extension processes post-Brexit to be among the many aspects of MHRA workings that almost mirror those currently in place with the EMA, though this might change at some point after January. If there are substantive changes, we will publish further guidance.
As we look across the regulatory landscape from our offices in the UK, Ireland and the Netherlands it is clear that post Brexit, the UK and its MHRA will continue to be an important market to help pharma and medical companies launch products and grow their business. There will be opportunities for the MHRA to innovate as a global regulatory authority. The recent announcement that the regulator will be joining the newly formed global country submission ACCESS Consortium is testament to this.
There is inherent risk in assuming ‘all will be well’ with UK licences through the Brexit transition and grandfathering. Take the time to check the situation for your products, especially those ‘in flight’, and act directly with the MHRA where needed. Taking specialist advice is prudent.
The Brexit negotiations are ongoing, but the deadline of 1st January 2021 is close. Diamond can provide the services and the agile response to ensure that your portfolio remains in compliance, and that opportunities are realised.
For more details and to speak to our team - contact James Wisely using the form below or call +44 (0)7876 664 543.