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. 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.