Brexit preparation.

Following the UK’s decision to leave the EU, it will be classed as a third country by the EMA
from March 29th, 2019.

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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Whatever the final outcome, we can help you.
There is a huge amount of ambiguity following the UK’s Brexit referendum in June 2016 and its intent to leave the EU. Nobody knows quite what the 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).

Whilst what will happen next is still unclear, what is clear are the implications and planning underway on the part of the EMA (European Medicines Agency). The EMA is working on the assumption that UK will be a third country as of 30th March 2019 and they are relocating to the Netherlands. They have information on Brexit here and continuity of activities here. Whatever happens, Brexit will create many challenges for companies who currently have their European hubs or EU Marketing Authorizations in the UK.

The likely options.

Great Repeal option

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

EEA option

The UK participates as non-EU member (European Economic Area, like e.g. Norway)

EFTA option

The UK develops agreements with the EU and joins 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

  • A MAH currently established in the UK will need to be replaced with one already established in the EEA, requiring an application for an MA transfer.
  • For medicinal products authorized via MRP/DCP, where the Reference Member State (RMS) is the UK, an MAH will need to change the base of the RMS to an agency of a member state of the EEA.
  • From the date of the UK’s withdrawal from the Union, medicinal products manufactured in the UK will be considered imported medicinal products.
  • For designated orphan medicinal products, the holder will need to transfer its designation to a holder established in the EEA.
  • If an EU batch release site is currently located in the UK, the MAH will need to transfer it to a location established in the EEA and perform a 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 PHV 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 infrastructure in place to ensure a seamless transition from pre-Brexit to post-Brexit. We can reduce the risk and remove the pain by managing the entire process for you.

  • We have an EEA based system and EU QPPV based outside the UK in the EEA.
  • We can act as your MAH in the EEA.
  • 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 updates & xEVMPD.
  • 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.


 

Many concerned companies have already contacted us to help them ahead of these impending changes, including other Regulatory Affairs and Pharmacovigilance service providers based in the UK.
We are considered by many as being a go-to organization to handle this impending issue.

Brexit becomes a reality on March 29th, 2019.
Make sure you’re ready by speaking to us now!

Whatever lies ahead, talk to us about your situation and what we can offer before it becomes an emergency.
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