Brexit is approaching: Regulations for Pharmaceuticals defined
The end of the transition period is approaching and no agreement is in sight. The European Commission has published a Communication to prepare for the end of the transition period. Although it is still the Commission's objective to conclude an "ambitious partnership covering all areas agreed with the United Kingdom" by the end of 2020, "negotiations so far have shown little progress". The document is appropriately entitled "Getting ready for changes - Communication on readiness at the end of the transition period between the European Union and the United Kingdom".
Far-reaching changes and consequences are therefore to be expected after 1 January 2021. And even if the EU and the United Kingdom decide on an agreement by the end of 2020, the future relationship will be very different from the current situation in the internal market with customs union. The purpose of this Communication is now to highlight "main areas of inevitable change and to facilitate readiness and preparations by citizens, public administrations, businesses and all other stakeholders for these unavoidable disruptions".
Trade in health, safety and environmental protection will be subject to certain Union rules (sectoral compliance) which prohibit or restrict the import and export of certain goods. And on 01 January 2021, the United Kingdom will exit the Union's regulatory system for medicinal products and medical devices.
This will have the following consequences:
- All marketing authorisation holders need to be established in the European Union;
- Testing and batch release sites will need to be located in the European Union;
- Qualified Persons responsible for pharmacovigilance and batch release (including investigational medicinal products) will need to be established in the European Union;
- Any clinical trials authorised in the Union will need to have a sponsor or a legal representative established in the European Union;
- Information and labelling will have to comply with Union requirements, including as regards co-labelling of medicines according to the terms of the marketing authorisation granted in the UK;
- The certification of medical devices will have to be carried out by notified bodies established in the European Union.