With the uncertainty that comes with considering the impact of the “B” word, guidance has recently been published by the European Commission and the European Medicines Agency (EMA) with regard to centrally authorised medicinal products for human and veterinary use. The guidance has been issued in the form of questions and answers concerning information related to establishment requirements; it aims to assist in preparing the industry for the consequences of the UK’s withdrawal from the European Union and can be found here.
The guidance proceeds on the basis that the UK will become a “third country” from 30 March 2019. There have been rumblings of dissatisfaction about the Q&A and the EMA’s “worst case scenario” vision amongst the ABPI and the BIA and we understand they have made their thoughts known to the EMA. While it is of course important for manufacturers to prepare for changes in good time, we have concerns as to whether an “exit before Brexit” approach, and the enormous cost and upheaval that would entail, is immediately justifiable. It remains difficult to predict the outcome of Brexit negotiations, with certain commentators predicting a ‘softer’ Brexit as more likely after the unexpected result in the recent general election. Our Life Sciences and Brexit teams will be monitoring the position and the EMA is expected to publish further guidance in due course.
As to the EMA itself, we are closely following the bidding process for the location of the agency and expect the British government to publish its formal position on this shortly.
The first of the questions is “What if I am a marketing authorisation holder established in the UK?” The answer provided is that for centrally authorised medicinal products, the marketing authorisation holder will normally need to transfer its marketing authorisation to a holder established in the Union (extended to include the EEA members Norway, Iceland and Liechtenstein).
Similarly, for an orphan designation holder established in the UK (for medicines for human use - question 2), the sponsor of the orphan medicinal product designation must be established in the EEA. Accordingly, the holder will need to transfer its designation or it will need to change its place of establishment to a Member State of the Union (or EEA) and submit the corresponding documents through a change of name and/or address of the orphan designation holder procedure, provided the legal entity remains the same.
If the Qualified Person for Pharmacovigilance (QPPV) resides and carries out tasks in the UK (question 4), they will be required to change their place of residence and continue to carry out their tasks in the EEA, or alternatively a new QPPV already residing and carrying out the tasks in the EEA will need to be appointed.
The same goes for Pharmacovigilance System Master File (PSMF) (question 5). The PSMF must be located within the EEA and therefore the marketing authorisation holder will need to change the location of the PSMF to a Member State within the EEA.
What about manufacturing sites and batch control (questions 6 to 8)?
When the UK eventually withdraws from the European Union, medicinal products that are manufactured in the UK will be considered imported medicinal products. A manufacturing authorisation will need to be obtained, which will be subject to certain conditions such as the availability of a QPPV within the EEA and GMP compliance.
For centrally authorised medicinal products, the marketing authorisation holder will need to change the location of any current UK based site of batch control to a location established in the EEA and submit the corresponding variation.
We will be monitoring further developments in this area.