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    Brexit and the EU regulatory framework for medicinal products

    The European Medicines Agency (EMA) and the European Commission have published guidance to help pharmaceutical companies to prepare for the United Kingdom's withdrawal from the European Union. The guidance relates to both human and veterinary medicines.

    The UK submitted on 29 March 2017 the notification of its intention to withdraw from the European Union. This means that - in the context of EU primary and secondary law - the UK will as of 30 March 2019 become a "third country". This may have consequences for marketing authorisation holders of centrally authorised medicinal products for human and veterinary use, because:

    • EU law requires that marketing authorisation holders are established in the EU (or the EEA including Norway, Iceland and Liechtenstein);
    • Some activities must be performed in the EU (or EEA), related for example to pharmacovigilance, qualified persons for pharmacovigilance (QPPVs) and companies' manufacturing and batch release sites.

    Preparing for the withdrawal of the UK is therefore not just a matter for European and national administrations, but also for private parties. Marketing authorisation holders need to proactively screen authorisations they hold and consider necessary changes to the terms of the marketing authorisation in order to ensure its continuous validity and exploitation, once the UK has left the Union.

    On 31 May 2017, EMA and the European Commission published a questions-and-answers (Q&A) document dealing with these implications and required changes. The guidance sees to, inter alia, the following issues:

    For centrally authorised medicinal products, the marketing authorisation holder established in the UK will need to transfer its marketing authorisation to a holder established in the Union (EEA). This means that the addressee of the marketing authorisation decision changes to the new addressee.

    The qualified person responsible for pharmacovigilance (QPPV) must reside and carry out his/her tasks in the Member State of the Union (EEA). A QPPV residing and carrying out his/her tasks in the UK will therefore need to change his/her place of residence and carry out his/her tasks in the Union (EEA) or a new QPPV residing and carrying out his/her tasks in the Union (EEA) will need to be appointed. Also the Pharmacovigilance System Master File (PSMF) must be located within the Union (EEA). The marketing authorisation holder may therefore need to change the location of the PSMF to a Member State within the Union (EEA).

    As of the date of the withdrawal, active substances and finished medicinal products manufactured in the UK will be considered imported active substances.  Active substances for medicinal products for human use shall only be imported in the Union (EEA) if, inter alia, the active substances are accompanied by a written confirmation from the competent authority of the exporting third country which, as regards the plant manufacturing the exported active substance, confirms that the standards of good manufacturing practice and control of the plant are equivalent to those in the Union (EEA). With respect to finished medicinal products manufactured in the UK, the import of such medicinal products into the Union (EEA) is subject to an authorisation by the competent authorities. The authorisation is granted when a number of conditions are fulfilled (e.g. availability of a qualified person within the Union (EEA), GMP inspection). For centrally authorised medicinal products the marketing authorisation holder will therefore need to specify an authorised importer established in the Union (EEA).

    In addition, the marketing authorisation holder will need to specify a site of batch control in the Union (EEA) where each production batch can undergo upon importation all required analysis and checks necessary to ensure the quality of medicinal products in accordance with the requirements of the marketing authorisation.  For centrally authorised medicinal products the marketing authorisation holder will need to change the location of its current UK based site of batch control to a location established in the Union (EEA) while a UK based site of batch release also need to be relocated to a location established in the Union (EEA).

    EMA is preparing a series of further guidance documents which will be published on its website in due course. Companies are advised to regularly check EMA’s dedicated webpage on the consequences of Brexit.