Guidance

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 valid UK marketing authorisation (MA).

The articles referred to below are in EU Directive 2001/82/EC, as amended.

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.

Types

The VMD has categorised the different types of batch release as follows.

Article 81 – not subject to retesting:

  • Type 81a – Marketing Authorisation Holder (MAH) requests release of batch(es) in the EU (ie. UK or other member states (MSs))

  • Type 81b MAH sends VMD a batch release certificate issued by another MS authorising release onto the UK market

  • Special – MAH requests release of batch(es) under this Article, which are out of specification. The VMD will consider these requests for release in the UK only

Article 82 – Subject to re-testing:

  • Type 82a – MAH requests release of batch(es) in the EU (ie. UK or other MSs)

  • Type 82b – MAH sends VMD a batch release certificate issued by another MS authorising release onto the UK market

Autogenous vaccine authorisations (AVAs)

AVA - The batch release arrangements are also applicable to autogenous vaccines, which are UK specific.

Further information about Article 82

Article 82 of the Directive allows an MS (if they wish) to request samples of each batch of a given specific type of IVMP to be submitted to a Competent Authority for official testing by an Official Medicines Control Laboratory before that batch is released onto the market.

The VMD is not applying Article 82a at the current time. The MAH can apply to the VMD for batch release of IVMP for which Article 82a applies. The batch will be treated as an Article 81a release and, if the batch meets the requirements for release, an Article 81 EU/EEA release certificate will be issued.

Further information about Special Release

Special Batch Release may be requested for a batch of IVMP where not all of 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.

VMD will review the batch release protocol and accompanying documentation. Further clarifying information may be requested by the VMD.

Depending on the outcome of the review the VMD will either approve or reject the request. If approval is granted, the batch of IVMP can be placed on the UK market only. In some instances approval may be given with conditions attached (eg. additional stability testing of the batch).

Autogenous vaccines

Autogenous vaccines (AVAs) by their nature are emergency vaccines and do not require prior approval from the VMD before being placed on the market. However, a batch release protocol must be submitted to the VMD at the time of release.

The batch of vaccine must not be released by the AVA holder until the purity, inactivation, sterility and on-farm safety tests have been completed and meet specification.

You may apply to release a batch of product that has not been manufactured in accordance with its MA, including in-process and final batch testing requirements. In this instance an assessment of the deviation from specification will be made by the VMD and if there is no risk to the animal and the vaccine is required on welfare grounds a special batch release may be granted.

How to apply

Submission

Send your BRR by email to batchr@vmd.defra.gsi.gov.uk

You may use Eudralink or normal email. Other secure email systems will not be accepted.

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 Special Batch Release should be followed.

All BRRs should be accompanied by a covering letter or page including the following information:

  • Type of BRR being applied for, eg. Type 81a
  • Product Name
  • Name and address of MAH
  • Name and address of manufacturer
  • MA / Vm Number
  • 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
  • Contact name and email address

For products subject to a MAPI, please also include:

  • the batch number of the original product and the unique batch number given to the MAPI product
  • the name and email address of the contact in the regulatory authority releasing the original batch
  • a copy of the label

The batch control documentation should be signed by the responsible QP; electronic signatures are acceptable.

Timescales

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, ie. Regulatory authority releasing the original batch of product for MAPIs.

Some requests will be considered urgent for animal welfare reasons; if you think your request is urgent, please state this in your covering email and provide justification to support it. If the VMD agrees, your request will be dealt with quicker.

Notification of outcome

Type 81a

You will receive a formal approval or non-approval certificate.

Type 81b

You will receive an acknowledgement of receipt by the VMD of the EU certificate informing you that the information provided is accurate, or requesting further information from you.

Special

You will receive an email informing you if the request is approved or refused.

Type 82a

Not applicable - the VMD does not currently apply Type 82a releases.

Type 82ba

You will receive an acknowledgement of receipt by the VMD of the EU certificate informing you that the information provided is accurate, or requesting further information from you.

Fees

The fee for submitting a BRR is £80.

The VMD now issues all invoices electronically, so you must provide a valid email address of where to send the invoice.

Contact

Email batchr@vmd.defra.gsi.gov.uk

Published 2 June 2015