The European Medicines Agency has had to dedicate considerable resources in dealing with the complex issues related to the UK’s decision to leave the European Union. In this article we look at one of the main questions highlighted by the EMA relating to UK Marketing Authorisation Holders and provide additional resources to assist you in better understanding how Brexit might impact on your business.
What if I am a marketing authorisation holder established in the UK?
The UK Marketing Authorisation Holders question is perhaps the most frequently asked question that we have fielded in our Brexit work. The agency says:
According to Article 2 of Regulation (EC) No 726/2004 the marketing authorisation holder must be established in the Union. Through the EEA Agreement this is extended to include also Norway, Iceland and Liechtenstein. For centrally authorised medicinal products the marketing authorisation holder will therefore normally need to transfer its marketing authorisation to a holder established in the Union (EEA)(see Commission Regulation (EC) 2141/96 and EMA human and veterinary Q&A on transfer). This means that the addressee of the marketing authorisation decision changes to the new addressee.
In May 2017 the European Medicines Agency issued a notice stating:
Preparing for the withdrawal is therefore not just a matter for European and national administrations, but also for private parties. 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.
Marketing authorisation holders will need to act sufficiently in advance to avoid any impact on the continuous supply of medicines for human and veterinary use within the European Union.
In particular, the Commission and the European Medicines Agency expect marketing authorisation holders to prepare and proactively screen authorisations they hold for the need for any changes. The necessary transfer or variation requests will need to be submitted in due time considering the procedural timelines foreseen in the regulatory framework.
An update to original Q & A document was issued on December 1st 2017 and covered the issue of applicants established in the UK. The document stated:
Any marketing authorisation applicant must be established in the Union (EEA). Therefore, for marketing authorisation applications (MAAs) that are expected to receive a Commission Decision after 29 March 2019, applicants established in the UK will need to change to a non-UK applicant established in the Union (EEA) before 30 March 2019.
Here are some handpicked articles from our website that we hope will help you when considering moving a marketing authorisation.
The UK has acted as Rapporteur or Co-Rapporteur for significant number of centralised procedures over the years. What effect will the relocation of the EMA to another EU member state have on such medicinal products? In this extract from the first of our regular Brexit whitepapers (from July 2016) we looked at the implications of Brexit on existing marketing authorisation holders.
The role of the UK as the Rapporteur or Co-Rapporteur is one of pivotal importance in this endeavour. If your company has used the UK as Rapporteur or Co-Rapporteur then you need to start preparing to move your marketing authorisation(s). As referenced below in the EMA notice, marketing authorisation holders will need to act in sufficient time to ensure continuous validity and exploitation of marketing authorisations.
The UK’s decision to leave the EU has cast a shadow of uncertainty over many sectors but none more so than the sector that is charged with ensuring patient safety. The article listed above looks at the pharmacovigilance concerns along with the possibility of skills shortages in the sector post Brexit.
In a pharmacovigilance context, the EU QPPV will need to be based in an EU member state. Again, we can help and we are helping many companies with this service at the moment.
For companies moving a marketing authorisation the next two years will be a difficult time. Marketing authorisations will have to be managed while the uncertainty of the outcome of the overall Brexit negotiations are being carried out.
In this blog we look at the initial steps that need to be taken when applying for a marketing authorisation for a pharmaceutical product within the EEA.
Right now, we are working with a significant amount of companies and helping them in moving their marketing authorisations to other EU member states. Our team of regulatory consultants and strategists is one of the largest in Europe and we are working on behalf of companies all Europe that are seeking to manage the issue in a timely manner in an effort to ensure that their product will remain on the market and available to patients throughout the period of Brexit negotiations and afterwards.
We can help you in moving a marketing authorisation. If you would like to have an initial discussion with us about moving a marketing authorisation/authorisations and the steps that you might need to take, then get in touch with us today by calling us on 00353 52 61 76 706 or simply complete you details below and we will get back to you as soon as possible.