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.
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, the바카라 사이트疢AH바카라 사이트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 the바카라 사이트疷K, the바카라 사이트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: MarketingInformationForm@mhra.gov.uk바카라 사이트�.바카라 사이트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).바카라 사이트�
European Commission바카라 사이트� centrally authorised products will no longer be authorised in Northern Ireland and all batches for sale or supply in 바카라 사이트媡he UK바카라 사이트�바카라 사이트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 a바카라 사이트疦IBSC바카라 사이트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 a바카라 사이트疦IBSC바카라 사이트痗ertificate for Great Britain and an바카라 사이트疎U Official Control Authority Batch Release (OCABR)바카라 사이트痗ertificate for Northern Ireland. However, if the batch does not have an바카라 사이트疧CABR바카라 사이트痗ertificate, we will accept the바카라 사이트疦IBSC바카라 사이트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 a바카라 사이트�바카라 사이트�바카라 사이트�바카라 사이트�바카라 사이트婲IBSC바카라 사이트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, 바카라 사이트�바카라 사이트媏xcept batches of vaccines and immunologicals whose바카라 사이트疧CABR바카라 사이트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.바카라 사이트�
3.5 Required checks聽
Ensure that you carry out the following checks:聽
1) Check the lot number matches on the바카라 사이트疷K바카라 사이트疢IF바카라 사이트痑nd batch release certificate. Note batch numbers may include extra suffixes (e.g. 86759-A) 바카라 사이트� 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 the바카라 사이트疷K바카라 사이트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 바카라 사이트� it may be supplied to the바카라 사이트疷K바카라 사이트痑nd also to other countries. Also check the expiry date on the바카라 사이트疷K바카라 사이트疢IF바카라 사이트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 your바카라 사이트疷K바카라 사이트疢IF, within 2 바카라 사이트�바카라 사이트�바카라 사이트媤orking 바카라 사이트媎ays. You will only hear further from us if there is a question about the바카라 사이트疷K바카라 사이트疢IF. If바카라 사이트痶he MHRA바카라 사이트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 the바카라 사이트疢AH바카라 사이트痶o formally release the batch to market.听
4. Expedited release notifications聽
A 바카라 사이트�7-day waiver바카라 사이트� 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 meet바카라 사이트疍HSC바카라 사이트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 the바카라 사이트疢AH바카라 사이트痳eleasing the batch.听
5. Further information聽
For further information, contact our Customer Services Centre at:바카라 사이트�
贰尘补颈濒:바카라 사이트�info@mhra.gov.uk바카라 사이트�
Telephone: 020 3080 6000聽
You can also email ControlTesting@mhra.gov.uk with urgent questions.
Updates to this page
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Updated to remove: 바카라 사이트�1. Subject to the UK providing written guarantees to the European Commission as provided for in Article 8 of EU Regulation 2023/1182 and following the entry into force and application procedure provided for in Article 14바카라 사이트� from document Apply to release a vaccine or a blood product to market
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바카라 사이트� Section 1 바카라 사이트� Added new overview section on how to apply to release a vaccine or a blood product to market in the UK 바카라 사이트� Section 2 바카라 사이트� Updated procedure for submitting a marketing information form (MIF) 바카라 사이트� Section 3 바카라 사이트� Updated procedure for certification, setting out process after Windsor Framework comes into effect on 1 January 2025 바카라 사이트� Section 5 바카라 사이트� Updated contact information
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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.