Certification of batches of immunological medicinal products or medicinal products derived from human blood or plasma products (including plasma pools) from 1 January 2021.
From 1 January 2021, Great Britain will no longer be subject to EU Directive 2001/83/EC (Article 114) and NIBSC will be a stand-alone National Control Laboratory.
The guidance provided below is for Great Britain (England, Scotland and Wales) and Northern Ireland.
In Great Britain, most batches of biological medicines will require national certification before they can be placed onto the Great Britain market. The exceptions are batches that have an EU Official Control Authority Batch Release (OCABR) certificate issued on or before 31 December 2020 or batches that were manufactured and certified by a country with whom the UK has a relevant Mutual Recognition Agreement (MRA). The UK will have an MRA in place to cover batches manufactured and released in Switzerland or Israel. The regime for national certification by NIBSC will be as follows:
Unless the batch has already been OCABR-tested and certified on or before 31 December 2020 or special MRA arrangements apply (see [1] below), you will need to send samples and documentation to NIBSC for all batches to be used in Great Britain.
Where NIBSC certification is required, 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 [2] below). Please contact us at cpb@nibsc.org to discuss specific arrangements for your 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.
Products supplied from the European Union to Great Britain:
Wholesale dealers in Great Britain that import biological medicines from the EEA will be required to check that each batch has an appropriate NIBSC or Mutual Recognition Agreement certificate before placing on the market in Great Britain. This information can be obtained from the product’s Marketing Authorisation Holder. See guidance on the responsibilities of wholesalers importing medicines into Great Britain and the new role of Responsible Person (Import).
Products supplied from Northern Ireland to Great Britain:
Products supplied from Northern Ireland to Great Britain will require the supplying manufacturer or wholesale dealer in Northern Ireland to confirm that a NIBSC or Mutual Recognition Agreement certificate is available before supplying a Great Britain wholesaler or other authorised person in Great Britain, such as a hospital. See further guidance on obtaining evidence of independent batch release certification and supply of medicines from Northern Ireland to Great Britain.
Biological medicines imported into Great Britain under a Parallel Import Licence:
Products placed on the market in Great Britain under a Parallel Import Licence will require a NIBSC certificate. Please follow the guidance above for batches for Great Britain, including the requirement to provide a UK Marketing Information Form and NIBSC certificate in advance of the product being placed on the market.
See further guidance on Parallel Import Licences.
Batches for sale or supply in Northern Ireland only:
In Northern Ireland, we will continue to accept EU Official Control Authority Batch Release (OCABR) certificates, without further product testing, for batches to be placed onto the Northern Ireland market, with the exception of batches of vaccines and immunologicals whose OCABR certificate was issued in a different EEA State to that in which the batch was manufactured. At least seven days prior to placing the product on the market, you must provide MHRA and NIBSC with a UK Marketing Information Form and a copy of the relevant certificate to the email address on the MIF.
A NIBSC certificate will be required for products marketed in Northern Ireland where there is no OCABR certificate.
If a NIBSC certificate is required please follow the guidance above that applies to Great Britain.
Batches for sale or supply in Great Britain and Northern Ireland:
If a batch of product with a United Kingdom Marketing Authorisation (UK) is placed on both the Great Britain and Northern Ireland markets, it will need a NIBSC certificate for Great Britain and an OCABR certificate for Northern Ireland. However if the batch does not have an OCABR certificate we will accept the NIBSC certificate for both Great Britain and Northern Ireland.
NIBSC will continue to certify batches destined for non-EU/EEA/UK countries.
For European Batch release, NIBSC can continue to offer batch release testing in liaison with a European OMCL via a subcontract arrangement. Please contact NIBSC on cpb@nibsc.org for further information.
Notes:
[1] The list of states with a Mutual Recognition Agreement in relation to independent batch release testing of biological medicines is: Switzerland, Israel
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.
[2] From 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.