The United Kingdom (UK) left the European Union (EU) on 31 January 2020. It became a third country on 1 February 2020. A transitional period lasting until 31 December 2020 was established in the agreement on the UK’s withdrawal. During this period – with some exceptions – the conditions and obligations laid down in EU law continued to apply for the UK. The transitional period has also expired and has not been extended.
As of 1 January 2021, EU pharmaceutical law as laid out in the ‘acquis communautaire’ still applies to Northern Ireland. The basis for this is the Protocol on Ireland/Northern Ireland. This Protocol forms part of the withdrawal agreement concluded by the EU and the UK that established the terms of the UK's withdrawal from the EU.
Implementation at the Paul-Ehrlich-Institut
As a result of Brexit, the Paul-Ehrlich-Institut (PEI) has further expanded its commitment and capacities to take over authorisation procedures and official batch and product testing in the European network of medicines authorities. The Paul-Ehrlich-Institut has also intensified its activities in the areas of clinical trial authorisations, scientific advice, inspections, and pharmacovigilance.
The relevant European bodies have established Brexit working parties, which publish European decisions and FAQs on different topics on their websites. The Paul-Ehrlich-Institut fully supports the comments made available thus far and the decisions made at the European level.
Notes for Applicants
The Paul-Ehrlich-Institut would like to draw particular attention to the fact that the following persons, functions, and activities must be located within the EU or the EEA for medicinal products authorised in the EU from 1 January 2021:
- Marketing authorisation holder (MAH) and applicant
- Batch control and release
- Quality Control (QC)
- Qualified Person (QP)
- Qualified Person for Pharmacovigilance (QPPV)
- Stufenplanbeauftragter (Graduated Plan Officer) pursuant to Section 63a of the German Medicinal Products Act (in an EU Member State)
- Pharmacovigilance Master File (PSMF)
The transfer of the functions and activities to the EU or the EEA should have taken place before 1 January 2021. However, in ongoing DCP approval procedures, the relevant changes can still be submitted with the day 106 or day 160 response.
In accordance with Directive (EU) 2022/642 amending Directives 2001/20/EC and Directive 2001/83/EC, derogations apply exclusively to marketing authorisations (MA) already granted in an MRP/DCP procedure in which at least one of the four countries of Cyprus (CY), Republic of Ireland (IE), Malta (MT), or Northern Ireland (UK(NI) is a Concerned Member State (CMS) and if the marketing authorisation was granted by the competent authorities of CY, IE, MT or UK(NI) for supply to their markets.
Starting on 1 January 2021, the following applies for medicinal products where at least one of the above persons/activities is based solely in the UK:
- They are no longer in compliance with the EU acquis and may not be placed on the market in the EU/EEA.
- Medicinal products already released and brought into the EU/EEA before 1 January 2021 may remain on the market.
- Batch control and batch release may take place in Northern Ireland.
Third country regulations apply to imports from the UK as of 1 January 2021- the details of the trade agreement between the EU and the UK must be observed.
According to the Protocol on Ireland/Northern Ireland, the national MAs issued for medicinal products by the United Kingdom in respect of Northern Ireland have to comply with Article 17 and 18 of Directive 2001/83. This means that they have to go through the decentralised procedure (DCP) or the mutual recognition procedure (MRP) if the applicant already holds a MA in an EU/EEA Member State (MRP) or applies for MAs in any EU/EEA Member State (DCP). Therefore, MA applicants who wish to obtain a MA for the UK in respect to Northern Ireland through one of the aforementioned procedures have to include Northern Ireland as a Member State (XI) in the scope of their MA application in the DCP or MRP. The UK was automatically transferred to XI (the official abbreviation for Northern Ireland) for all ongoing procedures and previously issued marketing authorisations via MRP/DCP in which the UK was still a Concerned Member State (CMS) after 31 January 2020.
MAHs are reminded to familiarise themselves with the rules in Northern Ireland that apply after the end of the transition period as specified in the Protocol on Ireland/Northern Ireland and to update their MAs as needed.
An agreement on the mutual recognition of inspections and GMP documents was included in the trade agreement between the EU and the UK, which was concluded on 30 December 2020..
Recognition of EU certificates for the batch release of blood products and vaccines by the Paul-Ehrlich-Institut
As of 1 January 2021 the United Kingdom (UK) will no longer participate in the mutual recognition of Official Control Authority Batch Release (OCABR) and Official Batch Protocol Review (OBPR) between the EU/EEA and the UK. The UK cannot issue EU/EEA OCABR/OBPR certificates and batch release certificates from the UK issued as of 1 January 2021 are no longer recognised in the EU/EEA.
However, in line with the Q&A of the EU Commission from 13 March 2020, it remains possible for individual Member States to use EU/EEA OCABR/OBPR certificates issued by the UK by 31 December 2020 as part of their release process for batches placed on their market after 31 December 2021 without requiring additional OCABR/OBPR testing for those batches.
The Paul-Ehrlich-Institut shares the view of the EU Commission and EDQM. It considers even after the end of the transition period on 31 December 2020 the EU certificates issued by the British authorities National Institute for Biological Standards and Control (NIBSC) and Veterinary Medicines Directorate (VMD) before 31 December 2020 in its own national batch releases to an unlimited extent. This approach is in line with many other EU/EEA Member States.