|Council of the European Union, European Parliament
|Official Journal of the European Union
|L 118, Pages 1-3
|Blog & Commentary, Legislation, News, Policy-making
Regulation (EU) 2022/641 - formally signed by the co-legislators on 12 April 2022 - introducing amendments to Regulation (EU) No 536/2014 as regards a 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. This is a text with EEA relevance.
Regulation (EU) No 536/2014 - also known as the Clinical Trials Regulation (CTR) - concerns clinical trials on medicinal products for human use. According to the Protocol on Ireland and Northern Ireland, the importation of investigational medicinal products from third countries into the European Union (EU) or Northern Ireland (NI) is subject to the possession of a manufacturing and import authorisation. These shall be in compliance with the obligations of the EU rules for clinical trials.
The United Kingdom (UK) in respect of NI as well as small markets of the EU (i.e. Malta, Ireland and Cyprus) that are dependent on supply of medicinal products from the UK, raised issues with respect to the ability of economic operators to comply with all the provisions of the rules for medicines after the end of the transition period provided for in the Withdrawal Agreement, including medicines used in clinical trials, having regard in particular to the importation requirements. The Commission Notice issued in January 2021 provided for a grace period of one year. Despite the transition period, it still proves difficult for certain operators to adapt as required by the Protocol.
The objectives of this draft law are to address the issues related to investigational medicinal products, to prevent an adverse impact on their supply and, as a result, on the execution of clinical trials authorised under CTR in NI Cyprus, Ireland and Malta. This proposal allows exceptionally that the manufacturing and import authorisation is not required for investigational medicinal products imported into Cyprus, Ireland, Malta and NI from parts of the UK other than NI, provided that certain conditions are fulfilled. For Cyprus, Ireland and Malta, this derogation is of a temporary nature as it is expected that these markets are gradually supplied through EU Member States. A transition period of 3 years is foreseen.
The draft law was tabled by the European Commission on 17 December 2021, delivering on commitments agreed in October 2021. It should be read in conjunction with proposed amendments to Directive 2001/20/EC and Directive 2001/83/EC. The proposed Directive was adopted by Member State representatives on behalf of the Council of the European Union on 9 March 2022, and by the plenary of the European Parliament on 7 April. The Act was formally signed by the co-legislators on 12 April 2022 and published in the Official Journal on 20 April 2022.
|Health, Internal Markets
|Brexit, Medicines | Medical Devices, Public Health
|Countries / Regions
|Cyprus, Ireland, Malta, United Kingdom
|European Union [EU]