Northern Ireland: EU Regulation with specific Rules published

"Regulation (EU) 2023/1182 of the European Parliament and of the Council of 14 June 2023 on specific rules relating to medicinal products for human use intended to be placed on the market in Northern Ireland and amending Directive 2001/83/EC" has been published in the Official Journal of the EU. Here are some key aspects:

  • Medicines centrally authorised in the EU (CAPs) are no longer automatically entitled to be marketed in Northern Ireland. UK marketing authorisation from the MHRA will be required.
  • The MHRA may permit the importation of medicinal products from Great Britain into Northern Ireland by holders of a wholesale authorisation (even without a corresponding manufacturing authorisation).
  • Verification by the wholesaler is no longer required: "Holders of a wholesale distribution authorisation shall not be required to: (a) verify medicinal products as referred to in Article 1(1) of this Regulation in accordance with Article 80, first paragraph, point (ca), of Directive 2001/83/EC".
  • The requirements of the EU Falsified Medicines Directive (FMD) and the associated Delegated Regulation (EU) 2016/161 relating to safety features for medicines will be repealed for Northern Ireland. This means packs placed on the market in Northern Ireland will no longer be allowed to carry EU safety features on secondary packaging (features to be completely removed or covered). See also respective MHRA document.
  • The packaging of all medicinal products placed on the Northern Ireland market must clearly state "UK only".

Go back


Stay informed with the GMP Newsletters from ECA

GMP Newsletter

The ECA offers various free of charge GMP newsletters for which you can subscribe to according to your needs.

To subscribe, please click here.