Update on the Clinical Trial Regulation – national implementing legislation introduced
The Clinical Trial Regulation (EU) No.536/2014 (“CTR”) is directly applicable in all EU Member States, however national legislation is required to address certain aspects of the CTR. The Minister for Health has recently signed legislation that will implement the CTR into Irish law. In this note, we provide a brief overview of the Irish national implementing legislation, highlight the transitional provisions applicable, and discuss the impact of this legislation on manufacturer’s licences for investigational medicinal products.
The European Union (Clinical Trials on Medicinal Products for Human Use) (Principal) Regulations 2022 (the “Principal Regulations”) implement the CTR in Ireland and set out the powers of the Health Products Regulatory Authority (“HPRA”). The Principal Regulations came into force on 2 March 2022. The European Union (Clinical Trials on Medicinal Products for Human Use) (National Research Ethics Committees) Regulations 2022 establish National Research Ethics Committees (“RECs”) for clinical trials and a National Office to administratively support the work of the National RECs. These Regulations came into effect on 31 January 2022.
As mentioned in Part 1 of “The Clinical Trial Regulation: Get Ready for Go-Live” series (available here), a transitional period will apply from 31 January 2022 to allow for clinical trials authorised under the Clinical Trial Directive (“CTD”) to move to the CTR. As a result, the CTD and the national legislation transposing the CTD (the European Communities (Clinical Trials on Medicinal Products for Human Use) Regulations 2004) (the “2004 Regulations”) will continue to apply until 30 January 2025 in respect of an application (i) submitted in accordance with the 2004 Regulations before 31 January 2022; and (ii) made on or before 31 January 2023, where the sponsor opted to make the application in accordance with the 2004 Regulations. A sponsor of a clinical trial that received a favourable opinion from an ethics committee in accordance with the 2004 Regulations and, in relation to which trial the HPRA granted an authorisation, must continue to comply with his or her reporting obligations under the 2004 Regulations until 31 January 2025.
Manufacturer’s Licences for Investigational Medicinal Products
Any manufacturer’s licence granted under the 2004 Regulations or the Medicinal Products (Control of Manufacture) Regulations 2007 to 2019 in respect of investigational medicinal products will continue to be in force as if granted under the Principal Regulations. An application made in respect of the grant or variation of a manufacturer’s authorisation under the Medicinal Products (Control of Manufacture) Regulations 2007 to 2019, which has not been determined prior to the coming into force of the Principal Regulations, shall be considered as if it were an application made under the Principal Regulations. Persons eligible for an exemption from the requirement to hold an authorisation for the manufacture/import of investigational medicinal products, who had commenced their activity before 31 January 2022, must submit an application to the HPRA to be listed on the Register of Exemptions by 31 March 2022. The Medicinal Products (Control of Manufacture) (Amendment) Regulations 2022 amend the Medicinal Products (Control of Manufacture) Regulations 2007 to remove investigational medicinal products from the scope of those regulations.
For further information on the CTR, you can access our recent briefings here: The Clinical Trial Regulation: Get Ready for Go-Live – Part 1 – Arthur Cox LLP, The Clinical Trial Regulation: Get Ready for Go-Live – Part 2 – Arthur Cox LLP and The Clinical Trial Regulation: Get Ready for Go-Live – Part 3 – Arthur Cox LLP.