The EU published a Communication to the Commission on the 17th Dec 2021, on the Approval of the content of a Draft Commission Notice on the application of the Union’s pharmaceutical acquis in markets historically dependent on medicines supply from or through parts of the UK other than Northern Ireland, and associated updates to Directives 2001/20/EC, 2001/83/EC, regulation 536/2014 and delegated regulation 2016/161.

This This communication extends the derogation first published in the EU Commission notice of the 25 January 2021 and sets out a reporting obligation on industry to notify the MHRA for medicines imported into Northern Ireland as described below:

In order to make use of the derogation foreseen in Article 20(b) of Directive 2001/83/EC for human medicinal products and Article 24(b) of Directive 2001/82/EC for veterinary medicinal products, marketing authorisation holders should notify the competent authority that granted the marketing authorisation of the product concerned (Cyprus, Ireland, Malta or Northern Ireland), specifying that – and why in their view - the above criteria of a ‘justifiable case’ in the sense of Article 20 (b) of Directive 2001/83, and of Article 24 (b) of Directive 2001/82, are fulfilled. For medicinal products to be placed on the market in Northern Ireland (NI), the competent authority is the MHRA. For centrally authorised products, the competent authority is European Medicines Authority (EMA).

Products approved in the UK before 31 January 2021

For products approved in the UK before 31 January 2021, the EU Commission Notice means that, for all UK licenced medicines within a company’s portfolio, companies will seek to make use of these flexibilities unless the MHRA is directly informed otherwise.

This will be the basis for MHRA enforcement.

The justifiable reason for using the flexibilities exists where each batch is released by a QP on an EU site, or a UK site demonstrating equivalent standards; and that the establishment is supervised. This is to ensure continued supply to Northern Ireland.

You only need to notify the MHRA if you no longer plan to apply these flexibilities to the products in your company’s portfolio.

You should email info@mhra.gov.uk providing details of each medicine which will not make use of these flexibilities.

For each medicine, you should provide:

product name
marketing authorisation number
strength/pack size
the reason why flexibilities are not required

Products approved in the UK after 31 January 2021

For products approved in the UK after 31 January 2021, the EU Commission Notice means that these flexibilities apply to all new products and you only need to notify the MHRA if you do not plan to make use of the flexibilities.

This will be the basis for MHRA enforcement.

The justifiable reason for using the flexibilities exists where each batch is released by a QP (Qualified Person) on an EU site or UK site demonstrating equivalent standards; and that the establishment is supervised. This is to enable industry to use existing manufacturing and supply chain logistics while the necessary changes are made to ensure continued supply to NI.

You should email info@mhra.gov.uk providing details of each medicine which will not make use of these flexibilities.

For each medicine, you should provide:

product name
marketing authorisation number
strength/pack size
the reason why flexibilities are not required

For new product applications via the decentralised procedure (DCP) or mutual recognition procedure (MRP) with UK(NI) as a Concerned Member State (CMS), the regulatory flexibilities as set out in the EU Commission Notice permit each batch of medicinal product to be tested and released by a QP on a site in the UK.

Webinar: Medicines Supply to Northern Ireland

A Medicines Supply for Northern Ireland webinar took place on Wednesday 2 and Thursday 3 February 2022.

Video recording

Importing medicines into Northern Ireland