Guidance

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.

To place a batch on the market of a member state you must follow the “EC Administrative Procedure for the Official Batch Release” (OCABR). You must inform the Competent Authority (CA) in each member state, 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).

A model of Marketing Information Form can be found on the EDQM website.

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: Aleksandra.Korzeniowska@mhra.gov.uk

Every MIF must be sent to MHRA Inspection, Enforcement and Standards Division for response.

Sending a Marketing Information Form

Check if your documentation is complete - a MIF and batch release certificate must be attached to the email.

Check the lot number matches on the 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 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 MIF is not later than that on the batch release certificate.

What you can expect from us

We will normally acknowledge receipt of your MIF, within 2 days. You will only hear further from is if there is a question about the MIF.

If MHRA does not object within 7 working days after sending the documents (MIF), 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.

Published 31 January 2018
Last updated 8 February 2018 + show all updates
  1. Updated information about the MIF process.
  2. First published.