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EDQM / All activities | News | 15 June 2021 | Strasbourg, France
On 26 May 2021, the European Directorate for the Quality of Medicines & HealthCare (EDQM) and the Eurasian Economic Commission (EEC) signed a memorandum of understanding.
News | 23 April 2021 | Strasbourg, France
The new Official Control Authority Batch Release (OCABR) Guideline for Pandemic COVID-19 Vaccine (Recombinant Spike Protein), containing the agreed list of tests to be performed by Official Medicines Control Laboratories (OMCLs) for OCABR, is now available and is in force from 20 April 2021.
News | 07 April 2021 | Strasbourg, France
The Guideline for Pandemic COVID-19 vaccine (mRNA) has been updated to include a model protocol for the submission of manufacturers’ data. In force since 12 November 2020, this key guideline presents the list of tests to be carried out by an Official Medicines Control Laboratory (OMCL) for Official Control Authority Batch Release (OCABR).
News | 19 January 2021 | Strasbourg, France
The Official Control Authority Batch Release (OCABR) Network for human vaccines and medicinal products derived from human blood and plasma and the National Institute of Biological Standards and Control (NIBSC, United Kingdom) have signed a memorandum of understanding (MOU) to renew, post-Brexit, the exchange and collaboration on common activities related to batch release of human vaccines and...
News | 13 January 2021 | Strasbourg, France
The European Directorate for the Quality of Medicines & HealthCare’s (EDQM) ISO 9001:2015 certificate has been maintained following the second surveillance audit of its quality management system on 7 and 8 December 2020 by the official French standardisation body Association française de normalisation (AFNOR), via AFNOR Certification (AFAQ).
News | 08 January 2021 | Strasbourg, France
The United Kingdom left the EU on 31 January 2020 and the transition period for Brexit, during which EU legislation still applied, is over as of 31 December 2020. A trade deal for relations after 31 December 2020 has been negotiated between the EU and the UK, but the deal does not include mutual recognition of Official Control Authority Batch Release (OCABR) of vaccines for human use, human blood...