The Official Control Authority Batch Release (OCABR) network for human vaccines and the Therapeutic Goods Administration (TGA), Australia have signed a memorandum of understanding (MOU) to increase the exchange and collaboration on common activities related to batch release of human vaccines. 

The MOU is in force from 4 December 2020. It makes the TGA an observer to the OCABR network for human vaccines and lays the framework for the sharing of information related to batch release activity in this field. Mutual recognition of certificates is outside the scope of this MOU. Mutual recognition of OCABR, as defined in EU legislation, would require a formal agreement between the EU and Australia that also included OCABR, e.g. MRA, ACAA. Nevertheless, the closer collaboration and information exchange facilitated by this MOU could help foster a basis for such activities in the future.

See also:

• Batch Release for Human biologicals: vaccines, blood and plasma derivatives
• Human OCABR Guidelines
• COVID-19 vaccines: release of guidelines critical for co-ordinated independent batch control by EU OMCLs