Regulation (EU) 2022/641

What it is

to ensure the continuity of supply of investigational medicinal products to Northern Ireland, as well as to Cyprus, Ireland and Malta. PROPOSED ACT: Regulation of the European Parliament and of the Council. ROLE OF THE EUROPEAN PARLIAMENT: the European Parliament decides in accordance with the ordinary legislative procedure and on an equal footing with the Council. BACKGROUND: Regulation (EU) No 536/2014 of the European Parliament and of the Council lays down the rules for investigational medicinal products intended to be used in clinical trials in the Union. According to the Regulation, read in conjunction with the Ireland/Northern Ireland Protocol to the UK Withdrawal Agreement, the importation of investigational medicinal products from third countries into the Union or Northern Ireland is subject to the holding of a manufacturing and import authorisation. The European Parliament adopted by 555 votes to 0, with 3 abstentions, a legislative resolution on the proposal for a regulation of the European Parliament and of the Council amending Regulation (EU) No 536/2014 as regards a derogation from certain obligations concerning investigational medicinal products made available in the United Kingdom with respect to Northern Ireland as well as in Cyprus, Ireland and Malta. Parliament adopted its position at first reading under the ordinary legislative procedure by taking over the Commission proposal. This Regulation is closely linked to the Directive aimed at ensuring the long-term continuity of supply of medicinal products to Northern Ireland from the United Kingdom and at addressing the remaining supply problems in Cyprus, Ireland and Malta. It aims to ensure the supply of investigational medicinal products to these same markets. The amendment to Regulation (EU) No 536/2014 aims to provide for derogations for medicinal products distributed in Northern Ireland, Cyprus, Ireland and Malta which are used as investigational medicinal products in clinical trials in these countries. Specifically, the amending regulation provides that the importation of investigational medicinal products from other parts of the United Kingdom into Northern Ireland and, until 31 December 2024, into Cyprus, Ireland and Malta is not subject to the holding of a manufacturing and import authorisation, provided that the following conditions are met: The Regulation will enter into force on the day of its publication in the Official Journal of the European Union. It should apply from 31 January 2022.

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