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Latest Brexit update: How MedTech and Pharma businesses need to prepare

July 31 2018

The withdrawal negotiations between the European Union and the United Kingdom is still ongoing. Important issues such as the standards of the protection of personal data transmitted to the UK while it was a Member State, remain unsolved. According to plan, the withdrawal agreement should be finalised in October 2018, accompanied by the declaration of the future relationship between the EU and the UK. This month, the EU published a new communication on how to prepare for the withdrawal of the UK from the EU on 30 March 2019.  

Until the withdrawal agreement is finalised, there is still several possible scenarios, and nothing is set in stone yet. If the withdrawal agreement is settled as planned in October 2018, it will leave just enough time to ratify it before 30 March 2019. This would mean that there might be an agreement on a transition period of up to 21 months, where partners will have time to make the final preparations for the UK’s exit. However, if the agreement is not ratified by then, we risk what the EU refers to as a “cliff-edge” scenario, where there is no transition period, but instead an immediate end of the current EU rules in relation to the UK.  In any case, we strongly recommend that UK-based researchers and SMEs, as well as those who are collaborating with UK-based partners, make sure that they are prepared and follow the EU’s recommendations.  

How businesses needs to prepare 

The European Commission’s communication is accompanied by a factsheet with “Seven things businesses need to know in order to prepare for Brexit”, which you can find here.  

The seven things includes; Certificates, Licences, and Authorisations which may no longer be valid in the EU if issued by UK authorities, so you may have to seek new ones issued by an EU27-based authority. This is particularly relevant for goods in the medical devices sector. The UK will be classified as a ‘third country’, which also mean that Prohibitions and Restrictions for Import/export of Products to and from the UK will change, as well as Customs and VAT procedures when trading with companies in the UK.   

How the MedTech and Pharma sector need to prepare 

The European Commission has also issued a list of preparedness notices, where you can check the most relevant changes for your sector. Find for example a notice on “medical products for human and veterinary use within the framework of the centralised procedure”, where the European Commission briefly explains the consequences of the UK’s withdrawal on the medical sector: 

Since the UK will become a ‘third country’ in the eyes of the EU after 30 March 2019, the EU rules in the field of medicinal products will no longer apply to the UK. This has the following consequences in the different areas of EU law on medicinal products: 

  • EU law requires that marketing authorisation holders are established in the EU; 
  • Some activities must be performed in the EU, related for example to pharmacovigilance, batch releases etc.  

The European Medicines Agency (which is relocating from London to Amsterdam) is responsible for the scientific evaluation, supervision and safety of medicines in the EU, and they expect marketing authorisation holders to prepare and proactively screen authorisations they hold for the need for any changes. It is important that all business affected by this prepare now in order to avoid disruptions.  

The European Commission and the European Medicines Agency have also published a Q&A document with more details clarifying this matter, which can be found here.  

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