Brexit: Legal Proposals adopted on the Supply of Medicines in Northern Ireland, Cyprus, Ireland and Malta

Recommendation

7/8 February 2023
Heidelberg, Germany

Combination Products
Medicinal Products/Drugs meet Medical Devices

The EU Commission has been working for some time to ensure a long-term supply of medicines from Great Britain to Northern Ireland and to solve the remaining supply problems in Cyprus, Ireland and Malta. Among other things, its own legislation on medicines should be changed and, in addition to Northern Ireland, countries that have so far had staked trade relations with Great Britain, such as Malta, Cyprus and Ireland, should benefit from certain exemptions for a certain period of time. Last year, the EU Commission proposed both a Directive and a Regulation. One objective was to ensure the supply of medicines for human use to Northern Ireland under the Ireland/Northern Ireland Protocol. Other points included:

• No re-batch testing of medicines imported into Northern Ireland from the UK if they have already undergone testing in the UK or EU.
• No manufacturing authorisations or import licences are required for medicines supplied from Great Britain to Northern Ireland under certain conditions.
• UK-based companies can use a single package and package leaflet when supplying markets in Great Britain and Northern Ireland. Separate packaging is not required.
• Malta, Cyprus and Ireland will benefit from certain exemptions for a period of three years. Thus, during this period, importers of medicines from the UK will not be required to have a manufacturing authorisation in these three countries, nor will these medicines have to undergo batch testing again if they have already been tested in the UK.

Now both the European Parliament (7 April 2022) and the Council (12 April 2022) have approved the further agreed texts of the Directive and the Regulation. These can enter into force on the day of their publication in the Official Journal of the European Union.

The points are summarised and explained in the corresponding Q&A document "Questions and Answers on Commission Proposal to ensure continued supply of medicines to Northern Ireland, as well as Cyprus, Ireland and Malta".