National batch certification by NIBSC
NIBSC carries out its own independent certification of batches of biological medicines for the UK.
Most batches of licensed biological medicines require NIBSC certification before they can be placed onto the UK market.
In addition, NIBSC independently assesses and certifies batches that are made in the UK, including those intended for other markets, as well as batches that are to be used exclusively in the UK.
- For batches that are shared with the EU, NIBSC determines, based on a risk-proportionate assessment, whether laboratory testing is required in addition to protocol review. In some cases, NIBSC accepts EU OCABRcertificates in lieu of independent laboratory testing.
- Batches that were manufactured and certified by a country with whom the UK has a relevant Mutual Recognition Agreement (MRA) do not require NIBSC certification. The UK currently has an MRA in place to cover batches manufactured and released in Switzerland or Israel (see footnote [1]).
Statutory fees apply that enable NIBSC to charge for certification, testing and associated work.
Procedure to follow if you want to place a batch on the market in the UK
Unless special MRA arrangements apply (see footnote), you will need to send samples and documentation to NIBSC for all batches that are intended to be used in the UK.
- Please submit samples and manufacturing protocol documentation as soon as available and (if applicable) evidence of previously obtained OCABR batch certification as soon as you have it. See instructions for the shipping of samples.
You must inform NIBSC of the intention to place batches of biological medicines on the UK market at least seven working days in advance. Please send a Marketing Information Form (MIF), together with copies of the relevant certificate(s) (NIBSC, OCABR or a certificate from a country with which the UK has a Mutual Recognition Agreement) to MarketingInformationForm@mhra.gov.uk. The MHRA has seven working days to object to the release before the batch can be placed on the market.
Further information is available here.
- Wholesale dealers that import biological medicines are required to check that each batch has an appropriate NIBSC certificate before placing on the market in Great Britain. Information about certificates issued by NIBSC can be obtained from NIBSC. See guidance on importing medicines and role of the Responsible Person (import).
All batches placed on the UK market under a Parallel Import licence will require a NIBSC certificate.
Please contact us at ControlTesting@mhra.gov.uk to discuss specific arrangements for your product.
For new products that require laboratory testing at NIBSC, please allow a minimum of six months for NIBSC to implement and validate the required test method(s) before routine batch testing and certification can commence.
What you can expect from us
The statutory turnaround time for NIBSC certification is 60 calendar days. However, in practice, our turnaround times are much shorter, as NIBSC endeavours to assess and certify batches, and review Manufacturer’s Information Forms (MIFs), as quickly as possible.
To support timely batch release, we offer parallel testing. In most cases, this involves samples being submitted ahead of the accompanying documentation, helping to meet your anticipated release date and minimise overall certification timelines.
Additional information
NIBSC continues to certify batches destined for non-EU/EEA/UK countries.
For European Batch release, NIBSC can provide batch release testing in liaison with a European OMCL via a subcontract arrangement.
Please contact us on ControlTesting@mhra.gov.uk for information on NIBSC contract testing services.
Footnote
The list of states with a Mutual Recognition Agreement in relation to independent batch release testing of biological medicines are:
Both Mutual Recognition Agreements include provisions allowing for the re-examination of batches by NIBSC where there are public health concerns. The Mutual Recognition Agreement for Israel covers vaccines only.