The Guideline for Pandemic COVID-19 vaccine (mRNA) has been updated to include a model protocol for the submission of manufacturers’ data. This key guideline has been in force since 12 November 2020 with the list of tests to be carried out by an Official Medicines Control Laboratory (OMCL) for Official Control Authority Batch Release (OCABR).

The full, updated version is available for download and will enter into force on 1 May 2021. The guideline is for use by OMCLs and manufacturers to ensure a codified and smooth process for timely release of these important vaccines.

Download the Pandemic COVID-19 Vaccine (mRNA Vaccine) (full version).

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