The European Commission and European Medicines Agency (EMA) have published a Q&A document (the EMA Q&A) concerning the legal consequences for marketing authorisation holders (MAHs) of centrally authorised medicines if the UK becomes a ‘third country’ after Brexit. The EMA Q&A provides further detail following the European Commission and EMA notice of 2 May 2017.
Although the EMA recognises on its Brexit webpage, that the future relationship between the UK and the EU is unknown at present, the EMA Q&A nevertheless assumes the worst-case scenario where no transitional agreement or deal is reached and the UK becomes isolated from the system when it exits from the EU (currently expected to be 31 March 2019).
The EMA states in the Q&A that it expects that MAHs will act sufficiently in advance to avoid any impact on the continuous supply of medicines within the EU. In particular the EMA expects that that necessary transfer and variation requests are submitted in due time. The EMA Q&A sets out guidance including the following:
- What if I am a marketing authorisation holder established in the UK? MAH must be established in the European Economic Area (EEA). Need to transfer the marketing authorisation to a MAH established in the EEA.
- What if I am an orphan designation holder established in the UK? The sponsor of an orphan medicinal product designation must be established in the EEA. Need to transfer designation to a holder established in the EEA or you will need to change its place of establishment to a Member State of the EEA.
- What if my Qualified Person for Pharmacovigilance (QPPV) resides and carries out his/her tasks in the UK? The QPPV must reside and carry out his/her tasks in a Member State of the EEA. QPPV needs to change place of residence and carry out tasks in the EEA or a new QPPV residing and carrying out tasks in the EEA will need to be appointed.
- What if my Pharmacovigilance System Master File (PSMF) is located in the UK? The PSMF must be located within the EEA. Need to change the location of the PSMF to a Member State within the EEA.
- What if my manufacturing site of the active substance is located in the UK? Active substances manufactured in the UK will be considered imported active substances. Active substances will only be permitted to be imported into the EEA if, inter alia, the active substances are accompanied by a written confirmation from the Medicines and Healthcare Products Regulatory Agency that the standards of good manufacturing practice and control applied are equivalent to those in the EEA.
- What if my manufacturing site of the finished product is located in the UK? Medicines manufactured in the UK will be considered imported medicines. Import will be subject an authorisation by the competent authorities of the EEA. Need to vary (see B.II.b.2) the marketing authorisation terms to specify an authorised importer established in the EEA and a site of batch control in the EEA whereupon importation batches can undergo qualitative and quantitative analysis to ensure quality.
- What if my batch release site is located in the UK? Need to transfer current UK based site of batch release to a location established in the EEA and submit the corresponding variation
The Coordination Group for Mutual Recognition and Decentralised Procedures – human (CMDh), has also published a corresponding Q&A document and notice for marketing authorisation holders of nationally authorised products for human use. Where applicable, similar answers were given to each of these questions. In addition the following question was answered:
- What if my Reference Member State (RMS) for a Mutual Recognition (MRP) or Decentralised Procedure (DCP) is the UK? RMS must be established in a member state of the EEA. Need to change the RMS to a competent authority of a Member State of the EEA.
Although the EMA expects MAHs to act in advance to ensure the continuous supply of medicines in the EU, we still do not know what the UK’s future relationship with the EU will be. Setting up new operations as above may be a significant exercise for some MAHs; the Association of the British Pharmaceutical Industry points out this could take a MAH several years.