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1. Overview聽

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鈥疢AH鈥痗an release the batch.听

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.听

You must inform the competent authority (CA) of your intention to place the batch onto the market using the .听

In the鈥疷K, the鈥疢edicines 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 ().听

2. Procedure for submitting a marketing information form (MIF)聽

Send the MIF and associated documents to the MHRA at: [email protected]鈥�.鈥嬄犅�

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

• a copy of the relevant batch release certificate聽

Refer to the for information about batch release certificates.听

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

3. Procedure for certification聽

3.1 Windsor Framework arrangement for medicines聽

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 2025, 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).鈥�

European Commission鈥� centrally authorised products will no longer be authorised in Northern Ireland and all batches for sale or supply in 鈥媡he UK鈥嬧�嬄爓ill 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.听聽

3.2 Batches for sale or supply in Great Britain only聽

If a batch of product with a UK marketing authorisation is placed on the Great Britain market, it will need a鈥疦IBSC鈥痗ertificate.听

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

Prior to 1 January 2025:聽聽

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鈥疦IBSC鈥痗ertificate for Great Britain and an鈥疎U Official Control Authority Batch Release (OCABR)鈥痗ertificate for Northern Ireland. However, if the batch does not have an鈥疧CABR鈥痗ertificate, we will accept the鈥疦IBSC鈥痗ertificate for both Great Britain and Northern Ireland.听

From 1 January 2025:聽聽

If a batch of product with a UK marketing authorisation is placed on the UK market, it will need a鈥�鈥嬧�嬧�嬧�婲IBSC鈥痗ertificate.听聽

3.4 Batches for sale or supply in Northern Ireland only聽

For batches certified prior to 1 January 2025:聽

We accept EU OCABR certificates, without further product testing, for batches to be placed onto the Northern Ireland market, 鈥嬧�媏xcept batches of vaccines and immunologicals whose鈥疧CABR鈥痗ertificate was issued in a different EEA state to that in which the batch was manufactured.听

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

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.听聽聽

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.鈥���

3.5 Required checks聽

Ensure that you carry out the following checks:聽

1) Check the lot number matches on the鈥疷K鈥疢IF鈥痑nd batch release certificate. Note batch numbers may include extra suffixes (e.g. 86759-A) 鈥� 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.听 2) Check the number of containers to be marketed (on the鈥疷K鈥疢IF) 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 鈥� it may be supplied to the鈥疷K鈥痑nd also to other countries. Also check the expiry date on the鈥疷K鈥疢IF鈥痠s not later than that on the batch release certificate.听

3.6. Receipt of marketing information form聽

We will normally acknowledge receipt of your鈥疷K鈥疢IF, within 2 鈥嬧�嬧�媤orking 鈥媎ays. You will only hear further from us if there is a question about the鈥疷K鈥疢IF. If鈥痶he MHRA鈥痙oes not object within 7 working days after sending the documents, you can place the batch on the market.听

It remains the responsibility of the鈥疢AH鈥痶o formally release the batch to market.听

4. Expedited release notifications聽

A 鈥�7-day waiver鈥� or expedited release can be granted if waiting for 7 days would mean that patients would not receive medicines.听

In those cases, mark your email appropriately and provide a reason (for example, stock shortages; need to meet鈥疍HSC鈥痠mmunisation 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.听

What you can expect from us聽

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鈥疢AH鈥痳eleasing the batch.听

5. Further information聽

For further information, contact our Customer Services Centre at:鈥���

贰尘补颈濒:鈥�[email protected]鈥���

Telephone: 020 3080 6000聽

You can also email [email protected] with urgent questions.