Guidance for marketing authorisation holders in the event of a no-deal Brexit.
The Department of Health and Social Care (DHSC) has undertaken an analysis of the supply chain for medicines, including radioisotopes and vaccines, which identified those products that are imported from the EU and the European Economic Area (EEA). Without a deal, the supply chains for these products may be affected by changes to border processes and procedures.
To address this issue DHSC is working with the relevant marketing authorisation holders to ensure that UK stockpiles of medicines are adequate to cope with any potential delays at the border that may arise in the short term.
In the event we leave the EU without a deal, based on the current cross-government planning scenario we will ensure the UK has an additional 6 weeks’ supply of medicines in case imports from the EU through certain routes are affected. This is the current planning assumption but will of course be subject to revision in light of future developments.
We are therefore asking pharmaceutical companies that supply medicines for NHS patients from, or via, the EU or EEA, to ensure they have a minimum of 6 weeks’ additional supply in the UK, over and above their business as usual operational buffer stocks, by 31 October 2019.
2. The Medicines Supply Contingency Planning Programme
To support this request DHSC has launched the Medicines Supply Contingency Planning Programme.
Through this programme we are seeking information about contingency plans put in place in respect of medicines that meet the relevant criteria. We will consider how the department may support suppliers in making arrangements following receipt of this information.
Separately, we recognise that there are some products that have short shelf lives and cannot be stockpiled. Where such products are at present imported to the UK from the EU/EEA via road haulage and roll-on, roll-off sea, road and rail routes, DHSC is asking suppliers to ensure they have plans in place to air freight those products to avoid any border delays that may arise in the event of a no-deal exit from the EU. We will consider here too how the department may support suppliers in making arrangements to meet this expectation.
3. What the Medicines Supply Contingency Planning Programme covers
The programme covers products that are prescription-only medicines and pharmacy-only medicines that come from or via the EU/EEA via road haulage and roll-on, roll-off sea, road and rail routes.
This programme does not cover:
- general sales list (GSL) products
- medicines directly entering the UK from outside of the EU/EEA
- medicines entering the UK from the Republic of Ireland
- counter-measures and those vaccines which form part of the national vaccination programme – as these are centrally procured they will not form part of the Medicines Supply Contingency Planning Programme
- medical devices and clinical consumables – the government is also developing contingency plans for these products
- investigational medicinal products
- products that have recently been discontinued, or will be prior to 31 October 2019
- products that are not marketed in the UK
- unlicensed medicines
- raw materials for medicines
4. Actions required from marketing authorisation holders
A letter from DHSC’s Chief Commercial Officer, Steve Oldfield, has been sent via email to:
- marketing authorisation holders for medicines that come to the UK from or via the EU or EEA
- UK medicine manufacturers that may be dependent on raw materials or components from or via the EU or EEA
This letter has been sent to a point of contact at your organisation. There is no requirement to respond to this letter. If you have not received the letter and believe you have medicines that fall within the scope of the programme, please email firstname.lastname@example.org.
In early July 2019, marketing authorisation holders supplying prescription-only or pharmacy medicines to the UK from or via the EU or EEA will be sent a password-protected response template. This will be sent to the point of contact at your organisation. The template has been pre-populated with:
- the medicines that DHSC considers are in scope of this programme and supplied by your organisation
- your preparedness to stockpile and re-route products as you described to us in the lead-up to a possible no-deal exit earlier this year
DHSC is requesting any updates or changes to that information to understand the status of your supply contingency plans.
DHSC will follow up separately through different channels about contingency plans for:
- suppliers of other licensed or unlicensed medicines to the UK with an EU or EEA touchpoint
- UK manufacturers that import raw materials or components from or via the EU or EEA
5. Where to find further information
As well as the template and the accompanying guidance, the email will include details of webinars that DHSC will be hosting for marketing authorisation holders. These will include the opportunity to ask questions. There will be several dates offered to ensure that all marketing authorisation holders have the opportunity to attend one of them.
The programme team can also be contacted at email@example.com and will aim to respond to all queries. We ask that companies wait until they have seen the guidance and attended a webinar before sending in any further queries to this email address.