Information concerning use of EU OBPR Certificates issued for IVMPs by the UK before 1 January 2021

End of mutual recognition of Official Control Authority Batch Release (OCABR)/Official Batch Protocol Review (OBPR) between the EU/EEA and the UK from 1 January 2021 (NEW)

The United Kingdom left the European Union on 31 January 2020 and the UK and the EU entered into transition period that was agreed as part of the Withdrawal Agreement, with a scheduled end on 31 December 2020. EU law continued to apply in the UK until the end of the transition period. In the context of EU/EEA OCABR/OBPR, this meant that until the end of the transition period, the UK could continue to participate in EU OCABR/OBPR as before, including for mutual recognition of EU/EEA OCABR/OBPR certificates, and that during that time EU/EEA OBPR* certificates issued by the UK would be valid in all EU/EEA member states.

A trade deal has been agreed between the EU and the UK to be applied after the transition period; however, this deal does not include mutual recognition of OCABR/OBPR for IVMPs between the EU/EEA and the UK. Therefore, as of 1 January 2021 the UK is no longer part of the mutual recognition of EU/EEA OCABR/OBPR for IVMPs foreseen in the EU legislation. The UK cannot issue EU/EEA OCABR/OBPR certificates and batch release certificates from the UK from this date forward will not be recognised in the EU/EEA.

* The UK did not perform OCABR and only issued EU OBPR certificates.

Use of EU/EEA OBPR certificates from the UK issued before 1 January 2021

The UK did not perform OCABR nor provide OCABR certificates for IVMPs; however, the UK was active in the EU/EEA Official Batch Protocol Review process (based on article 81 of the EU Directive for veterinary medicines 2001/82/EC as amended).  By agreement of the member states, the OBPR certificates resulting from this process were mutually recognised in the EU/EEA provided the codified procedure was followed.

In line with the EU Commission notice to stakeholders issued on 13 March 2020, individual member states can still use certificates issued by the UK on or before 31 December 2020 as part of their release process for lots placed on their market from 1 January 2021.

In order to facilitate the EU/EEA batch release process for IVMPs post-Brexit and to provide transparency for applicants, the EDQM has carried out a survey on behalf of the EU/EEA Veterinary Batch Release Network Advisory Group.

The following EU/EEA member states responded that they would take into account EU/EEA OBPR certificates issued by VMD, UK on or before 31 December 2020, for batches submitted for release from 1 January 2021 onward, as part of their own EU/EEA batch release process:

  • Austria
  • Belgium
  • Bulgaria
  • Czech Republic
  • Denmark
  • Finland
  • France
  • Germany
  • Hungary
  • Latvia
  • Netherlands
  • Poland
  • Portugal
  • Romania
  • Slovak Republic
  • Slovenia
  • Spain
  • Switzerland

Companies are strongly encouraged to liaise directly with member states for additional information or clarification, in particular for member states not listed above.

Please note that non-EU/EEA countries involved in mutual recognition with the Veterinary Batch Release Network through specific agreement with the EU (namely Switzerland) have in place their own agreements with the UK and should be consulted directly.

EDQM: Veterinary Batch Release Network 07/01/2021