GovWire

1. Overview

When a Marketing Authorisation Holder (MAH) wants to release a batch of a vaccine or a blood product to the UK market, they must get the batch independently tested and certified by the UK National Control Laboratory. After the UK certificate has been issued, the?MAH?can release the batch.

In accordance with the Human Medicines Regulation 2012, products in scope of this guidance include live vaccines, immunological products that are used in primary immunisations or public health immunisation programmes, new immunological products that are manufactured using new or altered kinds of technology or are new for a particular manufacturer, and products derived from blood or human plasma.

You must inform the Competent Authority (CA) of your intention to place the batch onto the market using the Marketing Information Form (MIF).

In the?UK, the?Medicines and Healthcare products Regulatory Agency (MHRA) is the CA and the UK National Control Laboratory as part of the MHRA is the National Institute for Biological Standards and Control (NIBSC).

2. Procedure for submitting a Marketing Information Form (MIF)

Please send the MIF and associated documents to the MHRA at: MarketingInformationForm@mhra.gov.uk?.?

Your documentation is only considered complete if both of the following documents are attached to your email:

• UK Marketing Information Form (MIF)
• a copy of the relevant batch release certificate

Please refer to the NIBSC guidance for manufacturers for information about batch release certificates.

Indicate on the MIF whether the batch will be placed on the market in Great Britain (England, Wales, Scotland) and/or Northern Ireland.

3. Procedure for certification

3.1 Windsor Framework arrangement for medicines

The Windsor Framework sets out the long-term arrangements for the supply of medicines in Northern Ireland. From the implementation of the Windsor Framework on 1 January 20251, the MHRA will license all medicines on a UK-wide basis and medicines will use the same packaging and labelling across the UK. All medicinal products (whether new or already on the market) will be authorised as Category 1 or Category 2 (as defined in section 4 of the UK-wide licensing for human medicines guidance).?

European Commission? Centrally Authorised Products will no longer be authorised in Northern Ireland and all batches for sale or supply in ?the UK??will require certification by the NIBSC. Sections 3.2 to 3.5 below explain the certification process for the sale and supply of batches before and after 1 January 2025.

3.2 Batches for sale or supply in Great Britain only

If a batch of product with a UK Marketing Authorisation is placed on the Great Britain market, it will need a?NIBSC?certificate.

3.3 Batches for sale or supply in the United Kingdom (Great Britain and Northern Ireland)

Prior to 1 January 2025:

If a batch of product with a UK Marketing Authorisation is placed on both the Great Britain and Northern Ireland markets, it will need a?NIBSC?certificate for Great Britain and an?EU Official Control Authority Batch Release (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.

From 1 January 2025:

If a batch of product with a UK Marketing Authorisation is placed on the UK market, it will need a?????NIBSC?certificate.

3.4 Batches for sale or supply in Northern Ireland only

For batches certified prior to 1 January 2025:

We accept EU OCABR certificates, without further product testing, for batches to be placed onto the Northern Ireland market, ??except batches of vaccines and immunologicals whose?OCABR?certificate was issued in a different EEA State to that in which the batch was manufactured.

For submissions which have been independently certified on or after 1 January 2025:

The same control testing (batch release) procedure will apply across the whole of the UK for biological medicines. Category 1 products (as defined in section 4 of the UK-wide licensing for human medicines guidance) will therefore require certification by NIBSC.

Batches manufactured and certified by a country with a Mutual Recognition Agreement with the UK will be accepted as an alternative to a certificate issued by NIBSC.?

3.5 Required checks

Please ensure that you carry out the following checks:

• 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, or different packaged lots from the same batch and the certificate contains the shared batch number.
• 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. Also check the expiry date on the?UK?MIF?is not later than that on the batch release certificate.

3.6. Receipt of Marketing Information Form

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

4. 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.

5. Further information

For further information, please?contact our Customer Services Centre at:?

Email:?info@mhra.gov.uk?

Telephone: 020 3080 6000

You can also email ControlTesting@mhra.gov.uk with urgent questions.