Specific rules relating to medicinal products for human use intended to be placed on the market of Northern Ireland

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Background

The proposed regulation sets out a comprehensive set of joint solutions agreed between the EU and the UK, providing derogations from certain obligations concerning certain medicinal products for human use made available in the UK in respect of Northern Ireland.

Jack O'Connor, EESC member and rapporteur of the opinion, highlighted: The proposed regulation is designed to ensure continuity of supply of medicinal products for human use in Northern Ireland, thus enhancing the prospects for implementation of the Protocol of Ireland/Northern Ireland. In other words, these solutions will allow manufacturers to maintain batch testing and regulatory functions in parts of the UK rather than transferring them to Northern Ireland.

Furthermore, the opinion recommends that the European institutions be updated periodically on the progress of implementation ahead of January 2025, which is set as the target implementation date.

Key points

In the opinion the EESC:

  • supports the adoption and early implementation of the proposed regulation, which would ensure continuity of supply of medicinal products for human use in Northern Ireland;
  • agrees that it is essential that the proposed regulation contains a provision enabling suspension of the specific rules by the Commission in the event of the UK's non-compliance;
  • encourages ongoing consultation with key stakeholders to help ensure timely implementation as well as monitoring for any future risks to the delivery of the objectives of the proposed regulation.

The full text of the opinion can be found here

Additional Information 

EESC section: External Relations Section (REX)

 Opinion type: Mandatory

Rapporteur: Jack O'Connor

Reference: REX/574-EESC-2023

Referral:COM(2023) 122 final 2023/0064 COD

Date of adoption by section: Not discussed in the section -urgent request

Date of adoption in plenary: 27 April 2023

Result of the vote: 154 in favor/0 against/0 abstentions

Contact

Millie Tsoumani, Press officer

 Tel.:+32 2 546 9088, email: Amalia.tsoumani@eesc.europa.eu

Sveto Trajkovski, Policy officer, Administrator

 Tel.:+32 2 546 9075, email: Sveto.Trajkovski@eesc.europa.eu

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