13/14 December 2023
The European Medicines Agency (EMA) has updated the agency's Brexit-related guidance documents. This guidance supports pharmaceutical companies in preparing for the United Kingdom's (UK) withdrawal from the European Union (EU). Now, the "Questions and Answers" document has been updated (Rev 04, published on 1 February 2019).
Some products need to be examined and tested by an Official Medicines Control Laboratory (OMCL) or a laboratory that a Member State has designated for that purpose before the release on the market. This is referred to as Official Control Authority Batch Release (OCABR). Products include immunological medicinal products, medicinal products derived from human blood or plasma or immunological veterinary medicinal products (see article 114 of Directive 2001/83/EC and article 82 of Directive 2001/82/EC). After successful examination and testing, a Control Authority Batch Release Certificate common to all Member States is issued. This Certificate is needed to release a batch for the EU/EEA market.
But what if a certificate is issued before the withdrawal date by the UK OMCL and released by the marketing authorisation holder after this date?
The answer is that it can not be released: "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 OCML when issuing a certificate."