The guideline for Pandemic COVID-19 vaccine, Inactivated, in force since 4 May 2022, contains the list of tests to be carried out by an Official Medicines Control Laboratory (OMCL) for Official Control Authority Batch Release (OCABR). It has now been updated to include a model protocol for the submission of manufacturers’ data. The full guideline is available for download and enters into force on 15 December 2022. The guideline is intended 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, Inactivated guideline.