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

From 1 January 2021, Great Britain is no longer be subject to EU Directive 2001/83/EC (Article 114) and the NIBSC is a stand-alone National Control Laboratory.

The guidance provided below is for Great Britain (England, Scotland and Wales) and Northern Ireland.

Batches for Great Britain

In Great Britain, most batches of biological medicines 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 the NIBSC will be as follows:

• Great Britain will carry out its own independent certification of batches of biological medicines at the NIBSC. The NIBSC will apply a risk-based approach to decide when to apply laboratory testing in addition to protocol review.
• The expectation is that the NIBSC will independently test and certify batches that are to be used exclusively in the UK.
• There will be new statutory fees to enable the NIBSC as the UK National Control Laboratory to charge for certification and testing in Great Britain, broadly the same as the current fees charged by the NIBSC in its role as an OCABR laboratory .
• You must inform the MHRA and the NIBSC of the intention to place batches of biological medicines on the market in Great Britain at least seven days in advance. Please send a UK Marketing Information Form (MIF) together with copies of the relevant certificate or certificates (NIBSC, OCABR or a certificate from a country with which the UK has a Mutual Recognition Agreement) to the email address on the MIF. Further information on the MIF process can be obtained from mif@mhra.gov.uk.
• Batches with OCABR certificates issued up to and including 31 December 2020 will be accepted by the United Kingdom, whether they have been issued by NIBSC or another OCABR laboratory. A copy of the OCABR certificate should be submitted with the UK Marketing Information Form.

Procedure to follow if you want to market a batch in Great Britain:

Unless the batch was already 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 the 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.

The 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 the 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, EU Official Control Authority Batch Release (OCABR) certificates for batches to be placed onto the Northern Ireland market will continue to be accepted, with the exception of batches of vaccines and immunological medicinal products whose OCABR certificate was issued in a different EEA State to that in which the batch was manufactured. These arrangements apply unless the product is subject to a waiver (for which further details are set out below) .

 At least seven days prior to placing the product on the market, you must provide the MHRA and the 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 or for batches of vaccines and immunological medicinal products whose OCABR certificate was issued in a different EEA State to that in which the batch was manufactured and which are not the subject of a waiver*.  

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 is placed on both the Great Britain and Northern Ireland markets, it will need a NIBSC certificate for Great Britain and the appropriate certificate for Northern Ireland (see Batches for sale or supply in Northern Ireland only).  If the batch does not have an OCABR certificate we will accept the NIBSC certificate for both Great Britain and Northern Ireland.

*Waivers for batches of vaccines and immunological medicinal products to be placed onto the Northern Ireland market whose OCABR certificate was issued in a different EEA State to that in which the batch was manufactured:

The MHRA/NIBSC may grant product-specific waivers following an application from the product’s Marketing Authorisation Holder.  One application that lists all products that are already on the NI market is acceptable.However waivers will be granted, and may in the future be revoked, on a product-by-product basis.

Waiver applications should be sent to cpb@nibsc.org.

Waiver applications may be refused, but the expectation is that most existing vaccines will be granted a waiver on the following terms:

• The product-specific waiver will exempt the Marketing Authorisation Holder from the need for a NIBSC certificate for vaccine batches that are destined for Northern Ireland but that are manufactured in a different EEA member state to the one in which it is OCABR certified provided that:
  • the batch has an OCABR certificate
  • the Marketing Authorisation Holder submits the OCABR certificate and a UK Marketing Information Form for each product batch to the MHRA (marketinginformationform@mhra.gov.uk) and does not place the batch on the Northern Ireland market until the Marketing Authorisation Holder has received confirmation of the MHRA’s acceptance of the batch.

• Waivers will remain in force until either:
  • The NIBSC revokes the waiver, giving the Marketing Authorisation Holder at least two year’s notice of any revocation, or
  • The NIBSC alerts the manufacturer to product-specific safety or quality concerns.  In this event, the NIBSC and the manufacturer will agree an immediate mechanism to allow the NIBSC to perform an appropriate level of quality review prior to placing batches on the NI market.

• Waiver applications for products new to the Northern Ireland market will be assessed on a case-by-case basis.
• The terms for new or products where concerns are raised will be agreed on a case-by case basis.

Additional information

The NIBSC will continue to certify batches destined for non-EU/EEA/UK countries.

For European Batch release, The 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.

Instructions for the shipping of samples to the NIBSC for independent batch release testing

Contact

For further information, please email our Customer Services Centre at info@mhra.gov.uk or call 020 3080 6000. You can also email cpb@nibsc.org with urgent questions. Alternatively, contact your Trade Association by emailing:

• Association of the British Pharmaceutical Industry (ABPI): regulatory@abpi.org.uk
• British Generic Manufacturers Association (BGMA): info@britishgenerics.co.uk
• BioIndustry Association (BIA): regulatory@bioindustry.org
• Clinical & Contract Research Association (CCRA): mail@ccra.org.uk
• Ethical Medicines Industry Group (EMIG): info@emig.org.uk
• Health Food Manufacturers’ Association (HFMA): pennyviner@btconnect.com
• The National Pharm acy Association (NPA): independentsvoice@npa.co.uk
• Proprietary Association of Great Britain (PAGB): regulatory@pagb.co.uk

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 the 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 the 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.