|Author (Corporate)||Council of the European Union, European Parliament|
|Series Title||Official Journal of the European Union|
|Series Details||L 118, Pages 4-13|
|Content Type||Blog & Commentary, Legislation, News, Policy-making|
Directive (EU) 2022/642 - formally signed by the co-legislators on 12 April 2022 - introducing amendments to Directive 2001/20/EC and Directive 2001/83/EC as regards derogations from certain obligations concerning certain medicinal products for human use made available in the United Kingdom (UK) in respect of Northern Ireland (NI), as well as in Cyprus, Ireland and Malta. This is a text with EEA relevance.
Directive 2001/20/EC - also known as the Clinical Trials Directive - set out basic principles for conducting clinical trials of medicinal products. Directive 2001/83/EC brought together all existing provisions in force on the sale, production, labelling, classification, distribution and advertising of medicinal products in the European Union (EU). According to the Protocol on Ireland and Northern Ireland, medicines placed on the market in NI must be covered by a valid authorisation issues by the European Commission (EU-wide) or the UK in respect of NI. These national authorisations shall be in compliance with the obligations of the EU rules for medicinal products.
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, which included mostly generics and over-the-counter medicines. 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 proposal are to address the issues related to the human medicinal products, to prevent shortages of medicines and ensure adequate level of public health protection in Northern Ireland, Cyprus, Ireland and Malta.
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 Regulation (EU) No 536/2014. 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.
|Subject Categories||Health, Internal Markets|
|Subject Tags||Brexit, Medicines | Medical Devices, Public Health|
|Countries / Regions||Cyprus, Ireland, Malta, United Kingdom|
|International Organisations||European Union [EU]|