The Pandemic COVID-19 vaccine (Recombinant Spike Protein) guideline, in force since 30 November 2021, 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 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 21 March 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 (Recombinant Spike Protein) guideline.