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(Withdrawn) Guidance for manufacturers of biological medicines - independent batch release in the United Kingdom from 1 January 2021  [1]

This content was withdrawn on 31 January 2020. See Control Testing for current information.

Certification of batches of immunological medicinal products or medicinal products derived from human blood or plasma products (including plasma pools) from 1 Jan 2021.

From 1 Jan 2021, the UK will no longer be subject to EU Directive 2001/83/EC (Article 114(1)). As outlined in section 1.16 in the further guidance published on 4 January 2019, NIBSC will be a stand-alone National Control Laboratory and the UK will require national certification by NIBSC before batches of biological medicines can be placed onto the UK market, unless the batch has an EU Official Control Authority Batch Release (OCABR) certificate issued on or before 1 Jan 2021 or was manufactured in and certified by a country with whom the UK has a mutual recognition agreement (MRA) in place (initially expected to cover batches manufactured and released in Switzerland or Israel).

The regime for UK certification will include the following changes:

• From 1 January 2021 the UK will carry out its own batch release of biological medicines at NIBSC taking a risk-based approach to laboratory testing. NIBSC will decide whether to rely on a paper assessment to issue the UK certificate or to carry out laboratory testing of the batch. NIBSC will review all data, including any release certificate issued by a laboratory in an approved list [2], where available, as well as potential risks to public health.
• If no such certificate is available, NIBSC will carry out a full laboratory assessment, except where NIBSC indicates differently.
• The expectation is that NIBSC will independently test and certify batches that are to be marketed exclusively in the UK.
• There will be new statutory fees to enable NIBSC as the UK National Control Laboratory to charge for certification and testing in the UK, broadly the same as the current fees charged by NIBSC in its role as an OCABR laboratory (PDF 89kb).

Please note: OCABR certificates issued up to and including 1 January 2021 would be accepted by the UK, whether they have been issued by the UK or another OCABR laboratory.

Procedure to follow if you want to market a batch in the UK from 1 January 2021:

• Please use the flow chart below to guide you.
• Unless the batch has already been OCABR-tested and certified on or before 1 January 2021 or special MRA arrangements apply, you will need to send us samples and documentation for all batches to be marketed in the UK.
  • Interim arrangements are foreseen for some products. Please contact us at cpb@nibsc.org for further information about your specific product.
  • NIBSC will endeavour to meet current batch release turnaround times and continue to offer parallel testing, which in most cases means submitting samples ahead of documentation to meet your anticipated release date.
  • Please submit documentation as early as possible, including evidence of any previously obtained independent batch certification if applicable.
  • To avoid delays in batch release please complete a sample submission form (Word 805kb). 

• If the batch does not require UK certification, please send us the relevant certificate and the new UK Marketing Information Form (Word 807kb). We will continue to follow the current Marketing Information Form (MIF) procedure.
• Please note that the current NIBSC UK certification process for batches destined for non-EU/EEA countries will remain unchanged.
• For European Batch release NIBSC can continue to offer batch release testing in liaison with a European OMCL via a subcontract arrangement. Please contact us if you are interested in this approach.

If you have not already spoken to us about your product or require further clarification, please contact us as soon as possible at cpb@nibsc.org.

[1]The content of this guidance will be updated as new information becomes available.

[2] From the 1 January 2021, for a fixed period NIBSC will review OCABR certificates issued by EU/EEA OCABR laboratories when deciding whether to rely on a paper assessment or to carry out laboratory testing of batches. The list of EEA states is:

Austria, Belgium, Bulgaria, Croatia, Republic of Cyprus, Czech Republic, Denmark, Estonia, Finland, France, Germany, Greece, Hungary, Iceland, Ireland, Italy, Latvia, Liechtenstein, Lithuania, Luxembourg, Malta, Netherlands, Norway, Poland, Portugal, Romania, Slovakia, Slovenia, Spain, Sweden

The list of states with a Mutual Recognition Agreement (MRA) in relation to independent batch release testing of biological medicines is:

Switzerland, Israel

Both MRAs include provisions allowing for the re-examination of batches by NIBSC where there are public health concerns.