BREXIT – Important Notice to Sponsors of Clinical Trials on Pharmaceuticals

Sponsors are hereby notified and reminded of the fact that due to the announcement of the United Kingdom (hereinafter referred to as the “UK”) of 29 March 2017 of their intention to leave the EU, from the perspective of effective legislation of the European Union (hereinafter referred to as the “EU ” ), as of 30 March 2019, the UK will become a “third country” and it is necessary to consider the legal consequences and impacts arising from the aforementioned in the sphere of clinical trials on medicinal products. The conditions which will be negotiated between the UK and the EU by that time shall be applicable also to the sphere of clinical trials.  

Consequences of the UK leaving the EU affecting the sphere of clinical trials:

  1. Investigational medicinal products
  • Please note that the site responsible for final batch release of medicinal products must be within the territory of the EU. With regard to the UK leaving the EU it may be anticipated that after the timeline of 30 March 2019 it will not be possible to conduct any final batch release of an investigational medicinal product to the EU by a qualified person from a site in the UK. Please be notified that no later than by March 2019 it is necessary to inform SÚKL on how continuity of supplies of the investigational medicinal products to patients is going to be safeguarded following the aforementioned timeline with regard to the conditions of Brexit. The change to the site responsible for final release must be submitted as a substantial amendment to the clinical trial, taking into account the 30-day timeline available to SÚKL for assessment.

     2. Sponsor / legal representative

  • If the sponsor of the clinical trial is from the UK, they will have to establish and authorise a “legal representative”, who will meet the condition of being established within the territory of the EU.
  • If a sponsor from a third country has a “legal representative” from the UK, they will have to appoint and authorise a new legal representative, who will meet the condition of being established within the territory of the EU.
  • The new “legal representative” or change to the “legal representative” shall be notified to SÚKL as a substantial amendment to the clinical trial, taking into account the 30-day timeline available to SÚKL for assessment.

18th October 2018

Clinical Trials of Medicinal Products Department