2/26/2019

The United Kingdom (UK) notified the European Union (EU) of its intent to withdraw effective March 30, 2019, a process commonly known as Brexit. At that point, it will become a “third country” and will not follow the EU regulations for pharmaceuticals. Negotiations are underway for a withdrawal agreement. The European Medicines Agency (EMA) and the European Commission have released guidance related to pharmaceutical companies’ distribution of drugs due to the uncertainty of authorization of a withdrawal agreement.

One guidance document is a list of questions and answers for what to do if the UK withdraws without an agreement. Questions focus on different scenarios such as:

If the marketing authorization holder is in the UK.
If the Qualified Person for Pharmacovigilance is UK based.
How inspection outcomes by the UK Competent Authority are affected.
If the Pharmacovigilance System Master File is located in the UK.
If the local representative mentioned in the product information is in the UK.
How to market a multi-country pack (labeling that is universal for a number of countries) that includes the UK.
If an Official Batch Protocol Review evaluation can be done by a UK Competent Authority.
How CE certification of medical devices by UK Notified Bodies is affected.

Another document provides practical guidance for procedures in submitting changes related to the UK withdrawal without an agreement. Key topics include:

How to transfer marketing authorization.
How to transfer orphan designation.
How to submit changes to the Qualified Person for Pharmacovigilance or Pharmacovigilance System Master File location.
Who the responsible party for a product released from the UK and supplied to the EU before withdrawal would be.
How submission of information to the EMA database will change.
- This includes how to report suspected unexpected serious adverse reactions (SUSARs) related to clinical trials conducted in the UK.
How Good Clinical Practice (GCP) inspections, Good Manufacturing Practice (GMP) certificates, and Good Laboratory Practice (GLP) status by UK authorities will be affected.

EU law states that marketing authorization holders must be established in the EU and that certain activities related to medicinal products must be conducted in the EU. It will be interesting to see how UK’s withdrawal from the EU affects efficiency of conducting clinical trials due to the complex nature of negotiating new regulations and restructuring processes and procedures in Europe.

- The Clinical Pathways Team

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