# Importing medicines into Northern Ireland Source: https://www.keypedia.com/records/uk_mhra_guidance/uk-mhra/a9cc46ef-832e-40bf-b9c1-7e5eba40e286 Type: Detailed Guide Published: March 9, 2021 Updated: March 16, 2022 > This guidance document details the UK MHRA's implementation of a European Commission Notice regarding the supply of human and veterinary medicines to Northern Ireland and other historically UK-dependent markets. The regulatory framework, rooted in EU Directives 2001/83/EC and 2001/82/EC, extends specific exemptions to ensure stable medicine access. Under these provisions, the MHRA allows medicinal products to be tested and released by a Qualified Person at sites within either the UK or the EU, provided equivalent standards are maintained and establishments are supervised. This policy applies to products approved both before and after January 31, 2021. The MHRA assumes that all pharmaceutical companies will utilize these regulatory flexibilities to maintain existing supply chains and manufacturing logistics while transitioning to long-term compliance measures. Consequently, enforcement is based on the automatic application of these flexibilities to all products. Required actions for companies: No proactive notification is necessary if the company intends to use these flexibilities. However, if a company chooses not to apply these exemptions to their portfolio, they must formally notify the MHRA via email. The notification must include specific product details, including the marketing authorization number and the rationale for opting out. This reporting obligation ensures that the MHRA and European Medicines Agency can effectively monitor the supply landscape in Northern Ireland. --- ## Content 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