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Brexit: Information concerning use of EU OBPR Certificates issued by the UK -update regarding the transition period

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EU OCABR/OBPR and the UK during the Brexit transition period (NEW)

The United Kingdom left the European Union on January 31st 2020 and the UK and the EU are in a time-limited transition period.  This transition period was agreed as part of the Withdrawal Agreement and will last until at least 31 December 2020.   Until the end of the transition period EU law will continue to apply in the UK.  In the context of EU OCABR/OBPR this means that until the end of the transition period, the UK will continue to participate in EU OCABR/OBPR as before, including mutual recognition of EU OCABR/OBPR certificates and during that time EU OCABR*/OBPR certificates issued by the UK will be valid in all EU member states.  The relationship between the EU and the UK with respect to EU OCABR/OBPR will be adjusted as necessary following the outcome of the negotiated agreement.

Additional information regarding the transition period is available here.

* The UK presently does not perform OCABR and issues only EU OBPR certificates.

Use of EU OBPR certificates post-transition period

The following news item from EDQM was initially published in 2019 and the text reflects the situation at that time i.e. before the withdrawal of the UK from the EU and the commencement of the transition period.  The principles would apply in the event that there is no agreement on mutual recognition following the transition period and would apply from the date agreed during negotiations.

In a Question and Answer document published on February 1, 2019 by the EMA and the EU Commission the following was stated:

19a. Can I, as of the withdrawal date, import a medicinal product into the Union (EEA) on the basis of a certificate issued before the withdrawal date by the UK OMCL?

No. As of the withdrawal date, the mutual recognition of Official Control Authority Batch Release (OCABR) stops.

However, the Official Medicines Control Laboratory (OMCL) of a EU27 or EEA Member State may take account of the certificate issued by the UK OMCL when issuing a certificate.

The UK does not perform OCABR nor provide OCABR certificates for IVMPs; however, the VMD, UK is active in the EU process of Official Batch Protocol Review (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 are mutually recognised in the EU provided the codified procedure is followed. In order to facilitate the EU 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 Veterinary Batch Release Network Advisory Group.  Member states were asked to give an indication if, in the event of a Brexit that does not include mutual recognition of OCABR/OBPR between the UK and the remaining EU member states, they would  take account of the EU OBPR certificates issued by the UK Competent Authority before the recognised deadline, for OBPR of batches received on their market after the recognised deadline.

The following EU/EEA member states responded positively that they would take into account EU OBPR certificates issued by VMD, UK on or before therecognised deadline, for batches submitted for release after the recognised deadline, as part of their own EU batch release process:

  • Austria
  • Czech Republic
  • Finland
  • France
  • Germany
  • Latvia
  • Netherlands
  • Poland
  • Portugal
  • Romania
  • Slovak Republic
  • Slovenia
  • Spain

Companies are strongly encouraged to interact with member states directly 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 06/03/2020

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