Metric	Value	Period
Total Revenue	9999999999999	FY2099
Net Income	-8888888888	FY2099
Earnings Per Share	123.456789	FY2099
Gross Profit	7777777777	FY2099
Operating Income	6666666666	FY2099

Metric	Value	Period
Total Revenue	9999999999999	FY2099
Net Income	-8888888888	FY2099
Earnings Per Share	123.456789	FY2099
Gross Profit	7777777777	FY2099
Operating Income	6666666666	FY2099

Independent batch release for vaccines and blood products

United Kingdom · Medicines and Healthcare products Regulatory Agency · Vaccines

Other routeHigh confidenceLast verified October 3, 2026

Review target

Not published

Legal time limit

Not published

Steps

3 requirements

Application fee

What is the Independent batch release for vaccines and blood products in United Kingdom?

Before each batch of certain vaccines and blood products is sold, it must be independently tested and certified by the UK National Control Laboratory, which is part of the MHRA. The holder can release the batch once the certificate is issued. Batches of live vaccines, immunisation program vaccines, new immunological products and products derived from blood or plasma.

What are the steps of the Independent batch release for vaccines and blood products?

1. Marketing information form; 2. Independent testing and certificate; 3. Batch release.

Outcome: A UK batch release certificate for each batch.

Legal basis: Human Medicines Regulations 2012 (batch testing of biological medicines)

How the pathway works

Each box is one step; arrows show the order. Dashed boxes happen only in some cases; the orange arrows go back (for example after questions).

ApplicantRegulatorCertification bodyCommitteeClock stopped

Timeline with clock stops

Official step durations

Steps

In order, with the official target for each step

1. Marketing information formThe holder tells the MHRA it plans to place the batch on the market, sending the form with the batch release certificate.
2. Independent testing and certificateThe UK National Control Laboratory (NIBSC, part of the MHRA) tests and certifies the batch.
3. Batch releaseAfter the UK certificate is issued, the holder can release the batch.

Requirements

What the applicant must provide or meet

Eligibility

Products in scopeLive vaccines, vaccines used in primary or public immunisation programs, new immunological products, and products made from blood or plasma.

Quality and manufacturing

NIBSC certificate for the UK marketBatches placed on the UK market need a NIBSC certificate.

Other

Official time targets

Targets, not actual review times

No time targets published.

Fees

Official amounts in the local currency

Fee	Amount
No fees published.

Other routes in United Kingdom: National assessment for innovative medicines, Biosimilar application, International Recognition Procedure, Recognition A, International Recognition Procedure, Recognition B, Project Orbis (cancer medicines), Conditional marketing authorisation, Authorisation under exceptional circumstances, Orphan designation, Early Access to Medicines Scheme (EAMS), Innovative Licensing and Access Pathway (ILAP), Rolling review, MHRA-NICE aligned pathway. See all routes on the United Kingdom page or explore them in the Regulatory section.

Not legal or regulatory advice. Check the current official rules before you act. This summary was checked against the official laws, regulations and regulator guidance on October 3, 2026 (9 facts checked). Parts of the approvals data are official open data reused under open licences. Data sources.