The new Official Control Authority Batch Release (OCABR) “Guideline for Pandemic COVID-19 Vaccine, Inactivated”, 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 4 May 2022. The availability of the list of tests, all of which have been adopted by the full OCABR network, will help OMCLs and manufacturers prepare for the launch of these anticipated vaccines in a smooth and timely manner.

The guideline is for use by OMCLs and manufacturers to ensure a codified and smooth process for timely release of these important vaccines.

The guideline is available for download from the European Directorate for the Quality of Medicines & HealthCare (EDQM) web page on OCABR activities related to COVID-19 vaccines:

• Guideline for Pandemic COVID-19 Vaccine, Inactivated (section 2 only)

See also:

• The EDQM’s contributions to the protection of public health in the COVID-19 pandemic: latest information
• General European OMCL Network (GEON)
• Questions and answers on OCABR