Turmoil for the UK healthcare markets continues to be unsettled, with the latest resignations within the UK government. 400 centrally authorized medicines have the UK as the licenceholder. The UK is a net exporter of patient packs to the EU27: 45 million/month exported; cf. 37 million/month imported.

European View

The European Commission in January 2018 stated:
‘In view of the considerable uncertainties, in particular concerning the content of a possible withdrawal agreement, marketing authorisation holders of centrally authorised medicinal products for human and veterinary use are reminded of legal repercussions,which need to be considered when the United Kingdom becomes a third country. Subject to any transitional arrangement that may be contained in a possible withdrawal agreement, as of the withdrawal date, the EU rules in the field of medicinal products for human and veterinary use no longer apply to the United Kingdom. This has, in particular, the following consequences in the different areas of EU law on medicinal products:

  • EU law requires that marketing authorisation holders are established in the EU (or EEA);
  • Some activities must be performed in the EU (or EEA), related for example to pharmacovigilance, batch release etc.

Marketing authorisation holders may be required to adapt processes and to consider changes to the terms of the marketing authorisation in order to ensure its continuous validity and exploitation, once the United Kingdom has left the Union.’

The facts that are in place are that the European Medicines Agency (EMA) expects UK-based MA holders to take steps before 30 March 2019 to make any necessary changes to their existing marketing authorisations or applications and/or transfer them to holders located in the EU. In addition, UK based pharma companies without an alternative EU base will need to transfer some or all of their operations to an EU member state.

The EMA practical guidance notes can be accessed via this link.

Questions and Answers related to the United Kingdom’s withdrawal from the European Union with regard to the medicinal products for human and veterinary use within the framework of the Centralised Procedure can be accessed via this link.

Republic of Ireland View

The UK agency – the Medicines and Healthcare products Regulatory Agency (MHRA) acted as the reference Member State for more than 3400 procedures. Many of which were with the Irish Republic where a language common pack could be shared. The Health Products Regulatory Authority (HPRA)has said that it plans to continue to work with the UK after Brexit to help to maintain dual labelling for products sold on both the UK and Irish markets, where possible. The updated EMA guidance confirms that the use of multi-country packs will only be possible in circumstances where the product labelling and package leaflet are fully in line with EU requirements, as EU law requires the summary of product characteristics to be the same in all markets.

The latest guidance from the HPRA can be found in this document.

Our Opinion

The UK agency has yet to issue further guidance since its January 2018 statement. Many medicines will be affected by the impact of the UK leaving the European Union in 2019. Several OTC medicines will be affected as they are either joint packs with Eire or part of a process linked to an agency no longer in European Union. Regulatory strategies need to be in place now to maintain product on both the UK or European markets to ensure these brands remain on the market.

OTCExperts can help formulate and execute these plans, please get in touch via Consultancy@otcexperts.co.uk

Expect more from us on the impact of Brexit for medical devices and food supplements later in the year.