Eurlexa

Article 1Subject MatterWithin the European Medicines Agency (the "Agency"),this Regulation provides for a framework for and the means of:(a)preparing for, preventing, coordinating and managing the impact of public health emergencies on medicinal products and on medical devices and the impact of major events on medicinal products at Union level;(b)monitoring, preventing, and reporting on shortages of medicinal products and on shortages of medical devices;(c)setting up an interoperable information technology (IT) platform at Union level to monitor and report on shortages of medicinal products;(d)providing advice on medicinal products that have the potential to address public health emergencies;(e)providing support for the expert panels provided for in Article 106(1) of Regulation (EU) 2017/745.

Article 2DefinitionsFor the purposes of this Regulation, the following definitions apply:(a)"public health emergency" means a situation of public health emergency recognised by the Commission in accordance with Article 12(1) of Decision No 1082/2013/EU;(b)"major event" means an event which is likely to pose a serious risk to public health in relation to medicinal products in more than one Member State, which concerns a deadly threat or otherwise serious threat to health of biological, chemical, environmental or other origin, or a serious incident that can affect the supply of or demand for medicinal products, or quality, safety or efficacy of medicinal products, which may lead to shortages of medicinal products in more than one Member State and necessitates urgent coordination at Union level in order to ensure a high level of human health protection;(c)"medicinal product" means a medicinal product as defined in Article 1, point (2), of Directive 2001/83/EC;(d)"veterinary medicinal product" means a veterinary medicinal product as defined in Article 4, point (1), of Regulation (EU) 2019/6 of the European Parliament and the CouncilRegulation (EU) 2019/6 of the European Parliament and of the Council of 11 December 2018 on veterinary medicinal products and repealing Directive 2001/82/EC (OJ L 4, 7.1.2019, p. 43).;(e)"medical device" means a medical device as defined in Article 2, point (1), of Regulation (EU) 2017/745 or an in vitro diagnostic medical device as defined in Article 2, point (2), of Regulation (EU) 2017/746, and includes accessories for such devices within the meaning of Article 2, point (2), of Regulation (EU) 2017/745, and Article 2, point (4), of Regulation (EU) 2017/746, respectively;(f)"supply" means the total volume of stock of a given medicinal product or medical device that is placed on the market by a marketing authorisation holder or a manufacturer;(g)"demand" means the request for a medicinal product or a medical device by a healthcare professional or patient in response to clinical need; the demand is satisfactorily met when the medicinal product or the medical device is acquired in appropriate time and in sufficient quantity to allow continuity of the best care of patients;(h)"shortage" means a situation in which the supply of a medicinal product that is authorised and placed on the market in a Member State or of a CE-marked medical device does not meet demand for that medicinal product or medical device at a national level, whatever the cause;(i)"developer" means any legal or natural person seeking to generate scientific data with regard to the quality, safety and efficacy of a medicinal product as part of the development of that product.

Regulation (EU) 2022/123 of the European Parliament and of the Council of 25 January 2022 on a reinforced role for the European Medicines Agency in crisis preparedness and management for medicinal products and medical devices (Text with EEA relevance)