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Brexit: Information concerning EU OCABR Certificates issued by the UK pre-Brexit

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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? (NEW)

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 Brexit deadline for OCABR of batches received on their market after the Brexit 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 official exit date from the EU, for batches submitted for release after Brexit, 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 agreeement 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 21/06/2019

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