Apply to release a vaccine or a blood product to market
Information for people who wish to apply to release a vaccine or a blood product to market in the UK.
Marketing Information Form
When a Marketing Authorisation Holder (MAH) wants to release a batch of a vaccine or a blood product to market, they must get the batch testing by an Official Medicines Control Laboratory (OMCL). Once the OMCL has issued a batch release certificate, the MAH can release the batch in all member states.
You must inform the Competent Authority (CA) using the Marketing Information Form (MIF).
In the UK, the CA is the Medicines and Healthcare products Regulatory Agency (MHRA) and the OMCL is the National Institute for Biological Standards and Control (NIBSC).
Procedure
Send the MIF and associated documents to the following contacts at MHRA:
- Prime contact: Marketing Information Form: MIF@mhra.gov.uk
- Second Prime Contact: Stephen.Young@mhra.gov.uk
- Secondary contact: cpb@nibsc.org
Batches with OCABR certificates issued up to and including 31 December 2020 will be accepted by the UK, whether they have been issued by NIBSC or another OCABR laboratory.
Sending a Marketing Information Form
Your documentation is only considered complete if both of these are attached to your email:
- UK Marketing Information Form
- a copy of the batch release certificate.
Indicate on the UK MIF whether the batch will be placed on the market in Great Britain (England, Wales and Scotland) only, Northern Ireland only or in both Great Britain and Northern Ireland.
Batches for sale or supply in Great Britain only
If a batch of product with a United Kingdom Marketing Authorisation (UK) is placed on the Great Britain market, it will need a NIBSC certificate or an OCABR certificate issued on or before 31 December 2020.
Batches for sale or supply in Great Britain and Northern Ireland
If a batch of product with a United Kingdom Marketing Authorisation (UK) is placed on both the Great Britain and Northern Ireland markets, it will need a NIBSC certificate for Great Britain and an OCABR certificate for Northern Ireland. However if the batch does not have an OCABR certificate we will accept the NIBSC certificate for both Great Britain and Northern Ireland.
Batches for sale or supply in Northern Ireland only
In Northern Ireland, we will continue to accept EU Official Control Authority Batch Release (OCABR) certificates, without further product testing, for batches to be placed onto the Northern Ireland market, with the exception of batches of vaccines and immunologicals whose OCABR certificate was issued in a different EEA State to that in which the batch was manufactured.
Check the lot number matches on the UK MIF and batch release certificate. Note batch numbers may include extra suffixes (e.g. 86759-A) – this is acceptable as long as the main number is the same.
Check the number of containers to be marketed (on the UK MIF) is less than or equal to the total number of containers in the batch. Note the number on the batch release certificate refers to the total size of the batch – it may be supplied to the UK and also to other countries. Check the expiry date on the UK MIF is not later than that on the batch release certificate.
What you can expect from us
We will normally acknowledge receipt of your UK MIF, within 2 days. You will only hear further from is if there is a question about the UK MIF. If MHRA does not object within 7 working days after sending the documents, you can place the batch on the market.
It remains the responsibility of the MAH to formally release the batch to market.
Expedited release notifications
A “7-day waiver” or expedited release can be granted if waiting for 7 days would mean that patients would not receive medicines.
In those cases, mark your email appropriately and provide a reason (i.e. stock shortages; need to meet DHSC immunisation schedule; competitor dropped out of market and need to ramp up production) for the 7-day waiver and we will review as a matter of urgency and acknowledge the receipt of this special request.
What you can expect from us
Where expedited release is justified, we will review the documents within 2 working days and, if the documents are in order, provide a confirmation that we will not object to the MAH releasing the batch.
Last updated 31 December 2020 + show all updates
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Following the end of the transition period, we have added a link to a revised MIF form and provided new information on what to provide for batches for sale in Great Britain only, Northern Ireland only, or in both areas.
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Change of text within Stay up to date box.
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Additional section added to the page with guidance for the OCABR (Official Control Authority Batch Release) Release and Marketing Information Form processes in the event the UK leaves the EU without a deal.
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Updated information about the MIF process.
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First published.