UK Brexit Preparedness – Medicines (UK Brexit)

Exit day is 31st October (127 days)

Today, 26th June, sees the following :

(1) Ministerial Statement – here

(2) Letter to Suppliers re Medicines – here

Ministerial Statement – extracts

Guaranteeing the supply of critical ‘category 1’ goods, including medicines, medical products, veterinary medicines and chemicals remains an essential element of the Government’s No Deal contingency planning. The Government is therefore undertaking steps to secure freight capacity for suppliers of these goods in a No Deal scenario.

The Department of Health and Social Care is starting the process of setting up an express freight contingency arrangement to support continuity of supply of medicines and medical products. This will be an urgent contingency measure for products requiring urgent delivery, within a 24-48 hour timeframe, if the UK leaves the EU without a deal. This express freight contingency arrangement forms part of the Department’s multi-layered approach, which includes rerouting medical supplies from the short strait crossings, extra warehouse space, stockpiling, buffer stocks, clarifying regulatory requirements, supporting traders to have all necessary paperwork in place at the border, and strengthening the processes used to deal with shortages to ensure that patients have uninterrupted access to medicines and medical products if the UK leaves the EU without a deal. Government will only pay for capacity as and when it is needed and used. This will be designed to cover all of the UK. The Department will be writing to industry to set out further details of these preparations.

The Department for Transport is putting in place a freight capacity framework agreement that will provide government departments with the ability to secure freight capacity for our critical supply chains as and when required. This framework does not commit the Government to purchasing or reserving any freight capacity, but it does provide a flexible list of operators and options for the provision of the capacity that can be drawn upon if needed.

In the coming months, the Government will make further announcements on its preparations for a possible No Deal Exit on 31 October, including on trade continuity agreements to limit disruption to our trade with third countries after we leave the EU.

Letter to Suppliers re Medicines – extracts

All no-deal preparedness plans should contain a mix of the following, depending on each company’s specific situation:

–  Secured capacity for rerouting freight away from the short straits after no-deal exit day, in order to avoid the worst restrictions on flow outlined above.

–  Stockpiling product above and beyond business-as-usual inventory levels; as a default, this is recommended as six weeks’ stock above business as usual inventory, the same as last time.

–  Assurance on the readiness of a company’s logistics and supply chains to meet the new customs and border requirements for both import and export (sometimes referred to as “trader readiness”).

Where companies have not yet done so [made a plan] the Government asks that they build a plan which includes a stockpile of an additional six weeks’ supply in the UK, on top of operational buffer stocks, in addition to developing a robust re-routing plan away from the short straits. As before, for products with a short shelf life or where production constraints mean stockpiling is not possible, for example, medical radioisotopes, we ask for alternative air freight plans to be made.

In the coming days, companies will be asked to provide information at product level, focused on the minimum key data set necessary for assurance of the programme. This will build on information from the 29th March exercise, including stock levels expected to be held on 31st October and plans for re-routing away from the short straits.

HPRA Medicines (Ireland Brexit)

The Health Products Regulatory Authority (HPRA), formerly the Irish Medicines Board, has now published its September to December Newsletter with Brexit content.

This newsletter is here.

This newsletter covers human and veterinary medicines, and gives key links to other information sources.

Note : the content is wider than Brexit, and sets out new legislative changes, with some details on the other EU26.

Medicines (UK and EU Brexit Preparedness)

UPDATE : the UK is consulting on making the MHRA standalone in the event of No Deal. The consultation is here. The MHRA is the UK Medicines and Healthcare Regulatory Agency.

Companies are reminded to plan for the UK’s withdrawal from the EU on 29 March 2019 and are advised to regularly check EMA’s dedicated webpage on the consequences of the UK’s withdrawal from the EU. In particular, EMA encourages companies to refer to the updated questions and answers and practical guidance for industry published on 19 June 2018.

While the evaluation of the risk of supply and shortages of centrally authorised medicines is on-going, all marketing authorisation holders are reminded to inform the Agency of any change of plans which may affect medicine supply to patients in Europe.

In addition, applicants submitting new marketing authorisation applications to EMA are reminded to ensure that the arrangements they are proposing in their application remain valid after Brexit and likewise make the necessary changes by 29 March 2019.

Companies are also reminded that, if they foresee a product supply issue with a medicine, they have a legal obligation to inform EMA.

The text in italics is part of the European Medicines Agency (EMA) press release issued today that informs that companies are stepping up and that the focus is now on 39 centrally authorised Medicines down from 108. The Press Release is here.

Marketing authorisation holders for over half of the 108 medicines have either taken steps to transfer their marketing authorisation to an EU27 country, change their qualified person for pharmacovigilance (QPPV), relocate their pharmacovigilance system master file (PSMF), adapt their logistics, supply chains and contracts, or relocate some manufacturing sites. According to EU law, the marketing authorisation holder, the QPPV, the PSMF and certain manufacturing sites need to be based in the European Economic Area (EEA) in order for a company to be able to market a medicine in the EU.

UK exits the EU (third country status)

I posted several times regarding EU Notices and Notices from EU regulatory agencies. These remind that the UK will be a third country (as respects the EU) on exit at 12pm CET 29th March 2019. If you have not already done so, please read these Notices.

Any Transition Period that is agreed is in the context of the EU-UK Withdrawal Treaty, and will continue certain EU arrangements only.

One of the aspects is UK membership of EU regulatory agencies (third countries are not members of EU regulatory agencies).

On 11th April 2018, the European Medicines Agency (EMA) confirmed that the EU27 member states and the EMA had completed the task of redistribution of the UK portfolio of centrally authorised medicine and veterinary products. The UK will not be a member of the EMA on its exit. Arrangements were already in place to relocate the EMA (from the UK) to an EU27 member state.

Please read the information that is published about this redistribution here.

UK exits the EU (medicines and veterinary products)

On 2nd May 2017 the European Commission and the European Medicines Agency (currently based in London) issued a Q&A document. This first list of questions and answers addresses the establishment requirements (within the EEA), and will be updated.

The document is here. From 30th March 2019 00:00 hrs (CET) the UK will be a (EEA) third country, and the following provisions will apply :

(1) marketing authorisation holders must be established in the EEA (this includes Norway, Iceland and Liechtenstein),

(2) Qualified Persons for Pharmacovigilance (QPPV) must reside and carry out their tasks within the EEA,

(3) the Pharmacovigilance System Master File (PSMF) must be located within the EEA,

(4) active substances manufactured in the UK will be considered imported active substances, 

(5) medicinal products manufactured in the UK will be considered imported medicinal products, 

(6) batch release sites (for certification) must be located in the EEA.