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.
Batch Protocol Review
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 batch release as follows:
- Batch Protocol Review (BPR) – MA Holder requests release of a batch
- Autogenous Vaccine Authorisation (AVA) – AVA Holder requests release of a batch in relation to an autogenous vaccine
- Marketing Authorisation for Parallel Import (MAPI) – MAPI Holder requests release of a batch in relation to a MAPI
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).
We recognise EU Official Batch Protocol Review (OBPR) and OCABR certificates issued by a relevant EU National Competent Authority for:
- products authorised in Northern Ireland via the Mutual Recognition or Decentralised procedure
- products authorised in Northern Ireland via the Centralised procedure
- existing UK wide MAs whereby the product is mutually recognised in Northern Ireland, but nationally authorised in GB and both parts of the authorisation are still subject to the same existing Vm 4000 authorisation number
Out of specification
Previously known as ‘special batch release’, you may request release of a batch of IVMP where not all the final product release tests meet specification or where manufacture does not fully comply with the MA.
A full justification as to why the batch does not meet specification along with assurances that the safety, efficacy and quality of the IVMP have not been compromised must be submitted with the batch release protocol.
We will review the batch release protocol and accompanying documentation and we may ask for further clarifying information.
Depending on the outcome of the review we will either approve or reject the request. If approval is granted the batch of IVMP can be placed on the UK market. In some instances approval may be given with conditions attached, for example additional stability testing of the batch.
Autogenous vaccine authorisations (AVAs)
Autogenous vaccines by their nature are emergency vaccines and don’t require prior approval from us before each batch is placed on the market. However you must send us a batch release protocol at the time of release.
You must not release the batch of vaccine until the purity, inactivation, sterility and on-farm safety tests have been completed and meet specification.
If it does not meet specification or has not been manufactured in accordance with its authorisation, including in-process and final batch testing requirements, you can apply to release a batch of product ‘out of specification’. If we are assured that there is no risk to the animal and the vaccine is required on welfare grounds, batch release may be granted.
How to apply
Batch release request documentation
You should submit the relevant documentation in accordance with the guidance available on the EDQM website. Model protocols for different product types are also available on the EDQM website and these should be used.
The manufacture of the batch of IVMP must be in full compliance with both the MA and Good Manufacturing Practice and include a declaration by the Qualified Person (QP). If not, the procedure for an out of specification batch must be followed.
All requests should be accompanied by a covering letter or email which includes:
- Type of batch release applied for (BPR, AVA, MAPI, or recognition of an EU certificate)
- If the product is ‘out-of-specification’, this should be clearly stated in the covering letter/email and all relevant information provided – see Out of Specification section
- Product name
- Name and address of MA Holder
- Name and address of manufacturer
- Marketing Authorisation number valid in the UK
- Batch number
- Batch number of diluent (if applicable)
- Type of container
- Total number of doses in this batch
- Number of doses per container
- Volume per container (in millilitres)
- Start date of period of validity
- Expiry date of the product
- Any deviations from the MA
- A contact name and email address
- Invoice email address, if different to the above
For products subject to a MAPI, you must also include:
- the batch number of the original product and the unique batch number given to the MAPI product
- a copy of the OBPR certificate approving release of the original batch
- a copy of the label
The batch control documentation should be signed by the responsible QP; electronic signatures are acceptable.
Send your BRR by email to email@example.com
BRRs will be processed within 10 days of receipt. The timescales will be suspended if further information is required from you, or other third party.
Some requests will be considered urgent for animal welfare reasons. If you would like us to consider prioritising your request, please tell us why in your covering letter/email.
Notification of outcome
We will notify you of the outcome by email.
The fee for submitting a BRR is £80, however there will be no fee:
- where we recognise a certificate issued by an EU National Competent Authority
- for batch release of autogenous vaccines
Fees apply regardless of the outcome (approved or refused) or if you withdraw your request. We issue all invoices electronically so you must provide a valid email address of where to send the invoice.