Northern Ireland: EU continues to look for Solutions - with interesting Forms of Documents

Recommendation

12/13 October 2023
Vienna, Austria

Qualified Person Forum 2023
Pre-Conference Sessions on 11 October 2023(with live online options)

Have you ever heard of a "non-paper"? That is the name given by the EU Commission to a new document that describes proposed solutions for the practical handling of problems within the framework of the Northern Ireland Protocol. The exact title is "Non-Paper: Medicines and the Implementation of the Protocol on Ireland and Northern Ireland"; it was published on 26 July.

Recently, the European Commission published a so-called "balanced package" of measures to solve some of the most pressing problems related to the implementation of the Protocol on Ireland and Northern Ireland (NI). So now this document, with a total of 13 points, including proposed solutions, when regulatory compliance functions for medicines authorised nationally by the UK for Northern Ireland may also be localised in Great Britain (GB) in exceptional cases. Here, for example, the relevant Union legislation on medicines must then be applied "on quality, safety, efficacy, pharmacovigilance and batch testing and release when issuing national marketing authorisations in respect to NI". Furthermore "supervision by the UK competent authorities on economic operators and regulatory compliance activities located in GB are carried out in accordance with applicable Union law".

Other points include:

• Products specifically approved for Northern Ireland may not be distributed within the EU. A database is to be introduced for this purpose.
• The Falsified Medicines Directive 2011/62/EU (FMD) must continue to be observed by the UK. To this end, Commission Delegated Regulation (EU) 2016/161 should be amended to provide for: "a derogation from decommissioning at export for UK single- and multi-market packs;" and "identification of UK single- and multi-market packs when they are verified in the EU repository system".
• Monitoring of imports from Great Britain to Northern Ireland after the end of the transitional period by the British authorities.
• Regular inspections to "verify compliance of the marketing authorisations  issued by the UK in respect to NI with relevant Union legislation and the specific conditions set out above."

One day later, on 27 July, the Commission published another document with examples from the areas of Sanitary and Phytosanitary (SPS) measures*, medicines, VAT and Tariff Rate Quotas (TRQ): Examples of flexibilities identified by the European Commission in an effort to facilitate the full implementation of the Protocol on Ireland/Northern Ireland.

For medicines, the proposal follows the above-mentioned "balanced package" to change the EU's own regulations. There will be a legislative proposal on these measures tabled in early autumn.

*Sanitary and phytosanitary (SPS) measures are, for example, quarantine and biosecurity measures against risks arising from the introduction, establishment and spread of pests and diseases.