Apply for batch release of an immunological veterinary medicine

Guidance on the Batch Release Request scheme for an immunological veterinary medicine to be placed on the UK market.

This guidance applies to Immunological Veterinary Medicinal Products (IVMP) only.

A batch of IVMP cannot be placed onto the market without a batch release request (BRR) being submitted to the VMD.

The IVMP must be subject of a Marketing Authorisation (MA) valid in the UK.

Products that have failed a batch release test should not be marketed. If you are found to have placed a failed product onto the market, the MA for that product will be revoked.

We have categorised the different types of immunological batch release as follows:

MA Holder requests release of a batch in relation to GB and/or NI MAs.

a) Batch Protocol Review (BPR) – You will need to apply for BPR (requiring submission of the batch protocol) from the VMD for most national MAs marketed in NI and/or GB.

b) Recognition of EU certificate (type 81a/81b) – We will recognise EU Official Batch Protocol Review (OBPR / OCABR) certificates issued by a relevant EU National Competent Authorities for: (1) NI MAs authorised via a European procedure – MRP/DCP/CAP (for placement onto the Northern Ireland market only) and (2) GB and NI aligned* MAs whereby the product is mutually recognised in Northern Ireland, but nationally authorised in GB (for placement on to both the Northern Ireland and GB markets).

Note: *Aligned - GB and NI MAs that are the same pharmaceutical form, have the same qualitative and quantitative composition, are intended for the same target species with the same indications and have a shared dossier.

We do not require samples of each batch of IVMP to be submitted for retesting for the purposes of batch release, however we retain the right to do so. This means that the UK does not currently require Official Control Authority Batch Release (OCABR).

Autogenous Vaccine Authorisation (AVA) – AVA Holder requests release of a batch in relation to an autogenous vaccine.