Brexit has started, so what next?

The UK formally left the EU on 31 January 2020, and it will be classed as a third country by the EMA.

A transition period began on 1 February 2020, during which EU pharmaceutical law remains applicable to the UK. This is due to end on 31 December 2020.

If you are based in the UK, hold an MA in the UK, or have your EU QPPV in the UK, you will be affected by the UK’s decision to leave the European Union.

We can offer a range of services to help you prepare for these impending changes and manage the transition from pre-Brexit to post-Brexit.

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We're ready to move...fast!

Whatever the final outcome, we can help you.
There are still many unknowns following the UK's decision to leave the EU. Nobody knows quite what the final impacts of Brexit will be, but you can be sure that we have all the support and services you will need to make a smooth transition to the new era of Anglo/EU pharmaceutical regulations.

The EMA (European Medicines Agency).

The final details of what happens next are still unclear, but the (European Medicines Agency) EMA has worked on the assumption that UK will be a third country from the 30th March 2019 and have relocated to the Netherlands. They have information on Brexit here and continuity of activities here. Whatever happens, Brexit will now create many challenges for companies who currently have their European hubs or EU Marketing Authorizations in the UK.

The possible options.

Great Repeal option

The UK converts current EU law into British law creating a no-change situation.

No EEA option

The UK will not now participate as non-EU member (European Economic Area, like e.g. Norway)

EFTA option

The UK develops agreements with the EU and joins or follows the European Free Trade Association like Switzerland.

Hard Brexit option

The UK develops its own laws and drug approval system.

How this could affect you.

Regulatory Affairs

  • MAH’s currently established in the UK with products in EEA markets, or established in the EEA with products on UK market, will need to be replaced with one already established in the corresponding region, through an MA transfer application.
  • For medicinal products authorized via MRP/DCP, where the Reference Member State (RMS) is the UK, a MAH will need to change the RMS to an agency of a member state of the EEA. A MA for the UK will be converted to a national procedure.
  • From the date of the UK’s withdrawal from the Union, medicinal products manufactured in either the UK or the EEA, will be considered imported medicinal products between the two states/regions.
  • For designated orphan medicinal products, the holder will need to transfer its designation to a holder in corresponding region.
  • If an EU batch release site is currently located in the UK, a MAH will need to transfer it to a location established in the EEA through variation submission.

Questions, answers and further information from the Heads of Medicines Agencies - Co-ordination Group for Mutual Recognition and Decentralised procedures - Human (CMDh) can be found here.

Pharmacovigilance

  • All EU QPPVs based in the UK should change their place of residence and carry out their tasks in the EEA.
    Alternatively, a new QPPV residing and carrying out their tasks in the EEA would need to be appointed.
  • If the PSMF is currently with a UK-based PV provider, it must be relocated within the EEA.

How we can help.

We offer a significant strategic advantage by providing an end-to-end service with Regulatory Affairs and Pharmacovigilance and have the legal and commercial infrastructures in place to ensure a seamless transition from pre-Brexit to post-Brexit, for both regions affected by Brexit (UK, EEA). We can reduce the risk and remove the pain by managing the entire process for you.

  • We can establish a Pharmacovigilance system both for an EU MAH located in EU, and or a UK MAH with a PSMF located in the UK at a point where the reports of suspected adverse reactions are accessible electronically or physically.
  • We can act as a MAH in the EEA and in the UK.
  • We can handle your RMS switching and prepare, publish and submit all the variations and transfers of MAs for your products.
  • We can handle all necessary PSMF & xEVMPD updates and adaptions to cover UK/EEA specific requirements.
  • We can establish a legal entity in the EEA and the UK on your behalf.

 


It is unfortunately inevitable that if you are based in the UK, hold an MA in the UK, or have your EU QPPV in the UK, you will be affected by the UK’s decision to leave the European Union. We also believe that companies or MAHs will need to be adapted to work with this situation.


 

Arriello is considered a go-to organization to handle these impending changes for Pharma companies and other Regulatory Affairs and Pharmacovigilance service providers based in the UK.

Download our full Overview and services brochure.

You'll find all about us, our services and what we can do for you in our Overview and services brochure, which you can download here.

Brexit has started!
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