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Brexit: Information concerning use of EU OCABR certificates issued by the UK – update regarding the transition period

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

The United Kingdom left the European Union on 31 January 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, this means that until the end of the transition period, the UK will continue to participate in EU OCABR as before, including mutual recognition of EU OCABR certificates and during that time EU OCABR 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 will be adjusted as necessary following the outcome of the negotiated agreements.

Find additional information regarding the transition period in the document "Questions and Answers on the United Kingdom's withdrawal from the European Union on 31 January 2020" (European Commission)

Use of EU OCABR certificates post-transition period 

The following news item from EDQM was initially published in 2019 and the text reflects the situation at that time, 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 be applicable from the date agreed during the negotiations. The EU Commission has replaced the Q&A document from February 2019 quoted below with a text from 13 March 2020.

In a Question and Answer document published on 1 February 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 an EU27 or EEA Member State may take account of the certificate issued by the UK OMCL when issuing a certificate.

In order to facilitate the EU OCABR process for vaccines for human use and medicines derived from human blood and plasma post-Brexit and to provide transparency for applicants, the EDQM has carried out a survey on behalf of the EU human OCABR Advisory Group. Member states were asked in April 2019 to give an indication if, in the event of a Brexit that does not include mutual recognition of OCABR between the UK and the remaining EU member states, they would take account of the EU OCABR certificates issued by the UK OMCL before the recognised deadline, for OCABR 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 OCABR certificates issued by NIBSC, UK, on or before the recognised deadline, for batches submitted for release after the recognised deadline, for their own EU batch release without requiring additional OCABR testing:

  • Austria
  • Bulgaria
  • Croatia
  • Cyprus
  • Czech Republic
  • Estonia
  • Finland
  • France
  • Germany
  • Greece
  • Hungary
  • Ireland
  • Italy
 
  • Latvia
  • Lithuania
  • Netherlands
  • Norway
  • Poland
  • Portugal
  • Romania
  • Slovak Republic
  • Slovenia
  • Spain
  • Sweden

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 human OCABR network through specific agreement with the EU, namely Switzerland and Israel (vaccines only), have in place their own agreements with the UK and should be consulted directly.

EDQM Human OCABR Network 06/03/2020

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