Guidance

Supplying investigational medicinal products to Northern Ireland

What you need to do to supply investigational medicinal products (IMPs) from Great Britain to Northern Ireland.

10 September 2021 update

In its July Command Paper, the Government set out proposals for a new balance in how the Protocol is operated.

In order to provide certainty and stability as discussions proceed between the UK and EU on these proposals, the Government has set out that it will continue to operate the Protocol on its current basis. This will mean that existing arrangements continue in force, including extending the specific arrangements/easements/grace period.

The Government will ensure that reasonable notice is provided in the event that any of these arrangements are to change, to enable businesses and citizens to make appropriate preparations.

Further information will be provided soon.

Supply of investigational medicinal products until 31 December 2021

IMPs can be supplied from Great Britain to Northern Ireland with a pragmatic approach to applying European Union (EU) rules on importation requirements until 31 December 2021. Apart from importation requirements, IMPs used in clinical trials in Northern Ireland must follow the EU acquis as per the Northern Ireland Protocol. This is as set out in the draft EU Unilateral Declaration in the Withdrawal Agreement Joint Committee.

Qualified Person (QP) certification will continue to be required to use an IMP in a UK, Northern Ireland or Great Britain clinical trial as per the requirements detailed in regulations 13(2) and 43 of the Medicines for Human Use (Clinical Trials) Regulations 2004 (as amended). QP certification done in Great Britain will enable supply of IMP to Northern Ireland until 31 December 2021. QP certification done in the EU/European Economic Area (EEA) will also enable supply of IMP to Northern Ireland via Great Britain until 31 December 2021.

Batch testing may be performed outside the EEA, including in Great Britain or Northern Ireland, where this is performed to standards equivalent to those required by the UK and EU. This will be permitted under regulations 13(2) and 43 of the Medicines for Human Use (Clinical Trials) Regulations 2004 (as amended) and will remain the case after 31 December 2021.

Supply of investigational medicinal products from 1 January 2022

From 1 January 2022, IMPs supplied from Great Britain to Northern Ireland will require importation via a manufacture and importation authorisation MIA(IMP) holder in Northern Ireland or an EEA state and certification by a Qualified Person named on the MIA(IMP).

Batch testing may be performed outside the EEA, including in Great Britain or Northern Ireland, where this is performed to standards equivalent to those required by the UK and EU. This will be permitted under regulations 13(2) and 43 of the Medicines for Human Use (Clinical Trials) Regulations 2004 (as amended).

It is important that clinical trial supply chains prepare for changes to Northern Ireland supply routes before 1 January 2022. There are other supply chain options that will not require importation controls to be performed in Northern Ireland or an EEA state. These include:

  • supplying IMPs to Northern Ireland directly from the EEA
  • changing the location of QP certification activities

Supply of authorised medicines used in clinical trials

Some clinical trials use unmodified authorised medicines as the investigational medicinal product, or as additional therapy in the trial design. Guidance on the requirements for supplying authorised medicines to Northern Ireland.

Further information

For further information, please email our Customer Services Centre at info@mhra.gov.uk or call 020 3080 6000. Alternatively, please contact the Proprietary Association of Great Britain (PAGB) by emailing regulatory@pagb.co.uk.

Published 31 December 2020