brexit

Are you conducting, or planning to conduct, a clinical trial in the UK/EU? Do you know what the impact will be on your submissions and clinical trials with a ‘no-deal’ Brexit? For a long time, we have heard about Brexit, and now the D-Day is fast approaching: 31st January 2020! Have you taken all the necessary measures to continue or start your clinical trial in the UK and EU?

If Brexit is ‘no-deal’, the Medicines & Healthcare products Regulatory Agency (MHRA) has put in place new rules that will need to be complied with for clinical trials in the United Kingdom. Also, a no-deal Brexit would impact clinical trials conducted in the EU. For example:

New submission portal: the MHRA has launched their new portal for Clinical Trials submissions. Besides, in this portal, you can perform other applications for medicinal products such as Paediatric Investigation Plans (PIPs) and some vigilance activities, as well as applications for e-cigarettes. If you are not registered yet, we recommend to do it now, following the MHRA reference guide that you can find here. Note, submission of Individual Case Safety Reports (ICSRs) will require using a different portal also set up by the MHRA.

  • Logistics with Investigational Medicinal Products (IMPs): Arrangements need to be in place to ensure continuity of the supply chains for IMPs (including placebos), but also for medical devices/in-vitro diagnostics devices, advanced therapy medicinal products, radioisotopes, and other clinical consumables. Two scenarios are depending on where your trial is ongoing:
  1. Importing IMPs from the UK to the European Union (EU): If the IMP Manufacturer License (MIA) holder is based in the UK and your trial is ongoing in other EU countries, you need to add an import and release (QP) site in the EU. This requires the submission of a substantial amendment to the EU competent authorities.
  2. Importing IMPs from the EU to the UK:  EU and EEA countries will be part of the ‘approved country for import’ list. If the IMP importer/QP is based in the EU, you will require a UK Manufacturing and Import Authorisation (MIA(IMP)) holder to put in place an assurance system to check these IMPs have been certified by a QP in a listed country, before releasing to the trial. However, IMPs that have been QP certified in a listed country will not require recertification in the UK.

Note: For both scenarios, don’t forget that the Manufacturers License (MIA) number for the manufacturing site to which the QP belong to should be listed on the QP declaration

  • Legal Representation: if your legal representative is based in the UK and the clinical trial is ongoing in the UK and the EU, you need to assign a new legal representative based in the EU for the European sites. Nevertheless, if your legal representative is in the EU, the UK will continue to accept European legal representation and no UK contact point will be necessary.

For additional questions, refer to the New UK regulation after the Brexit: “The Human Medicines (Amendment, etc.) (EU Exit) Regulations 2019”, and don’t forget to visit the MHRA website which is regularly updated.

Keywords: Brexit, UK, no-deal, European Union, MHRA, submissions, applications, clinical trials, Investigational Medicinal Products (IMPs), Qualified Person (QP), EU legal representative

Jannette_Hernandez

 

Jannette Mabelly Hernandez Olvera, Regulatory Scientist, Clinical Trial Submission and Operations