12/13 October 2023
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:
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.