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)

CHAPTER I

GENERAL PROVISIONS

Article 1

Subject Matter

Within 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 2

Definitions

For 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 Council (¹);

(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.

CHAPTER II

MONITORING AND MITIGATING SHORTAGES OF CRITICAL MEDICINAL PRODUCTS AND MANAGEMENT OF MAJOR EVENTS

Article 3

Executive Steering Group on Shortages and Safety of Medicinal Products

The MSSG shall be responsible for fulfilling the tasks referred to in Article 4(3) and (4) and Articles 5 to 8.

The MSSG shall meet regularly and also whenever the situation requires, either in person or remotely, in preparation for or during a public health emergency or when an issue of concern has been raised with the MSSG or when the Commission has recognised a major event in accordance with Article 4(3).

The Agency shall provide the secretariat of the MSSG.

Members of the MSSG may be accompanied to meetings of the MSSG by experts in specific scientific or technical fields.

The list of the members of the MSSG shall be published on the Agency’s web portal.

A representative of the Agency’s Patients’ and Consumers’ Working Party (‘PCWP’) and a representative of the Agency’s Healthcare Professionals’ Working Party (‘HCPWP’) may attend meetings of the MSSG as observers.

The co-chairs of the MSSG, on their own initiative or at the request of one or more members of the MSSG, may invite, as observers and to provide expert advice, representatives of national competent authorities for veterinary medicinal products, representatives of other relevant competent authorities and third parties, including representatives of medicinal product interest groups, marketing authorisation holders, wholesale distributors, any other appropriate actor in the supply chain for medicinal products, and representatives of healthcare professionals, of patients and consumers, to attend its meetings, as necessary.

The rules of procedure referred to in the first subparagraph shall enter into force once the MSSG has received a favourable opinion from the Commission and the Management Board of the Agency.

The working party referred to in the first subparagraph shall consist of representatives of the national competent authorities for medicinal products, who shall be the single points of contact in relation to shortages of medicinal products.

Article 4

Monitoring of events and preparedness for public health emergencies and major events

Where a national competent authority informs the Agency of a shortage of a medicinal product as referred to in the first subparagraph, it shall provide the Agency with any information that it has received from the marketing authorisation holder pursuant to Article 23a of Directive 2001/83/EC, if that information is not available in the ESMP.

Where the Agency receives a report of an event from a national competent authority for medicinal products, the Agency may request information from the national competent authorities, through the working party referred to in Article 3(6), in order to evaluate the impact of the event in other Member States.

Following a positive opinion of the MSSG, the Commission may recognise the major event.

The Commission or at least one Member State may raise the issue of concern with the MSSG on its own initiative.

On the basis of the information referred to in the first subparagraph or on its own initiative, the Commission or the Executive Director may confirm that the major event has been sufficiently addressed and therefore that the assistance of the MSSG is no longer needed.

Following the recognition of a public health emergency or the recognition of a major event in accordance with paragraph 3 of this Article, Articles 5 to 12 apply as follows:

(a) where the public health emergency or the major event may affect the quality, safety or efficacy of medicinal products, Article 5 applies;

(b) where the public health emergency or the major event may lead to shortages of medicinal products in more than one Member State, Articles 6 to 12 apply.

Article 5

Evaluation of information and provision of recommendations on action in relation to the quality, safety and efficacy of medicinal products related to public health emergencies and major events

Article 6

Lists of critical medicinal products and information to be provided

The MSSG shall update the major event critical medicines list whenever necessary until the major event has been sufficiently addressed and it has been confirmed that the assistance of the MSSG is no longer needed pursuant to Article 4(4) of this Regulation.

The Agency shall establish within its web portal a publicly accessible webpage that provides information on actual shortages of medicinal products included in the critical medicines lists in cases in which the Agency has assessed the shortage and has provided recommendations to healthcare professionals and patients. The webpage shall provide at least the following information:

(a) the name and common name of the medicinal product on the critical medicines lists;

(b) the therapeutic indications for the medicinal product on the critical medicines lists;

(c) the reason for the shortage of the medicinal product on the critical medicines lists;

(d) the start and end dates of the shortage of the medicinal product on the critical medicines lists;

(e) the Member States affected by the shortage of the medicinal product on the critical medicines lists;

(f) other relevant information for healthcare professionals and patients, including information on whether alternative medicinal products are available.

The webpage referred to in the first subparagraph shall also provide references to national registries on shortages of medicinal products.

Article 7

Monitoring shortages of medicinal products on the critical medicines lists

Following the recognition of a public health emergency or the recognition of a major event in accordance with Article 4(3), the MSSG shall monitor the supply of and demand for medicinal products included on the critical medicines lists, with a view to identifying any actual or potential shortages of those medicinal products. The MSSG shall conduct such monitoring using the critical medicines lists and the information and data provided, in accordance with Articles 10 and 11, and available through the ESMP, once it is fully functional.

For the purposes of the monitoring referred to in the first paragraph of this Article, where relevant, the MSSG shall liaise with the Health Security Committee established by Article 17 of Decision No 1082/2013/EU (‘HSC’) and, in the case of a public health emergency, with any other relevant advisory committee on public health emergencies established pursuant to Union law and with the ECDC.

Article 8

Reporting and recommendations on shortages of medicinal products

Where requested by the Commission or one or more single point of contact as referred to in Article 3(6), second subparagraph, the MSSG shall provide aggregated data and demand forecasts to support its findings and conclusions. In that regard, the MSSG shall:

(a) use data from the ESMP, once it is fully functional;

(b) liaise with the ECDC to obtain epidemiological data, models and development scenarios to help forecast medicinal product needs; and

(c) liaise with the Executive Steering Group on Shortages of Medical Devices referred to in Article 21 (‘MDSSG’) where medicinal products included on the critical medicines lists are used jointly with a medical device.

The aggregated data and demand forecasts referred to in the first subparagraph may also be made available to other actors in the supply chain for medicinal products, where appropriate, in accordance with competition law, with a view to better preventing or mitigating actual or potential shortages of medicinal products.

Member States may request the MSSG to provide recommendations on measures referred to in the first subparagraph.

For the purposes of the second subparagraph, the MSSG shall liaise, as relevant, with the HSC and, in the case of a public health emergency, with any other relevant advisory committee on public health emergencies established pursuant to Union law.

Article 9

Working methods and provision of information on medicinal products

In order to prepare for the fulfilment of the tasks referred to in Articles 4 to 8, the Agency, shall:

(a) specify the procedures and criteria for establishing and reviewing the critical medicines lists;

(b) specify the methods of and criteria for the monitoring, data collection and reporting provided for in Articles 4, 7 and 8, with a basic minimum data set;

(c) develop streamlined IT monitoring and reporting systems, in coordination with the relevant national competent authorities, that facilitate interoperability with other existing IT systems and IT systems under development until the ESMP is fully functional, on the basis of data fields that are harmonised across Member States;

(d) establish the working party referred to in Article 3(6) and ensure that each Member State is represented on that working party;

(e) establish and maintain a list of single points of contact for marketing authorisation holders for all medicinal products authorised in the Union, through the database provided for in Article 57(1), point (l), of Regulation (EC) No 726/2004;

(f) specify the methods for the provision of recommendations referred to in Article 5(2) and Article 8(3) and (4) and for the coordination of measures referred to in Article 8(5);

(g) publish information covered by points (a), (b) and (f) on a dedicated webpage on its web portal.

For the purposes of the first subparagraph, point (a), Member States, marketing authorisation holders, other relevant actors in the supply chain for medicinal products and representatives of healthcare professionals, of patients and consumers, may be consulted as necessary.

Following the recognition of a public health emergency or the recognition of a major event in accordance with Article 4(3), the Agency shall:

(a) establish a list of single points of contact for the marketing authorisation holders for the medicinal products included on the critical medicines lists;

(b) maintain the list of single points of contact referred to in point (a) for the duration of the public health emergency or major event;

(c) request relevant information on medicinal products on the critical medicines lists from the single points of contact referred to in point (a) and set a deadline for the submission of that information, if that information is not available in the ESMP;

(d) request information on medicinal products on the critical medicines lists from the single points of contact referred to in Article 3(6), second subparagraph, on the basis of the set of information referred to in Article 6(4), and set a deadline for the submission of that information, if that information is not available in the ESMP.

The information referred to in paragraph 2, point (c), shall include at least:

(a) the name of the marketing authorisation holder of the medicinal product;

(b) the name of the medicinal product;

(c) the identification of active manufacturing sites for finished products and active substances of the medicinal product;

(d) the Member State in which the marketing authorisation is valid and the marketing status of the medicinal product in each Member State;

(e) details of the actual or potential shortage of the medicinal product, such as actual or estimated start and end dates and suspected or known cause;

(f) sales and market share data of the medicinal product;

(g) available stocks of the medicinal product;

(h) the forecast of supply for the medicinal product, including information on potential vulnerabilities in the supply chain, quantities already delivered and projected deliveries;

(i) demand forecasts for the medicinal product;

(j) details of available alternative medicinal products;

(k) shortage prevention and mitigation plans that include, at a minimum, information on production and supply capacity and approved production sites of the finished medicinal product and of active substances, potential alternative production sites and minimum stock levels of the medicinal product.

Article 10

Obligations on marketing authorisation holders

The marketing authorisation holders referred to in the first subparagraph of this paragraph shall submit the requested information by the deadline set by the Agency, through the single points of contact referred to in Article 9(2), point (a), using the monitoring and reporting methods and systems established pursuant to Article 9(1), points (b) and (c), respectively. Those marketing authorisation holders shall provide updates where necessary.

The Agency shall assess the merits of each indication of information as being of a commercially confidential nature and protect such commercially confidential information against unjustified disclosure.

Following the reporting on the results of the monitoring referred to in Article 7 and any recommendations on preventive or mitigating measures provided in accordance with Article 8(3) and (4), the marketing authorisation holders referred to in paragraph 2 shall:

(a) provide any comments they have to the Agency;

(b) take into account any recommendations referred to in Article 8(3) and (4) and any guidelines referred to in Article 12, point (c);

(c) comply with any measures taken at Union or Member State level pursuant to Articles 11 and 12;

(d) inform the MSSG of any measures taken and report on the monitoring and results of those measures, including providing information on the resolution of the actual or potential shortage of medicinal products.

Article 11

Role of Member States in the monitoring and mitigation of shortages of medicinal products

In order to facilitate the monitoring referred to in Article 7, unless the information concerned is available on the ESMP, the Agency may request a Member State to:

(a) submit the set of information referred to in Article 9(2), point (d), including available and estimated data on volume of demand and demand forecasts, through the single point of contact referred to in Article 3(6), second subparagraph, using the reporting methods and systems established pursuant to Article 9(1), points (b) and (c), respectively;

(b) indicate the existence of any commercially confidential information and explain why that information is of a commercially confidential nature, in accordance with Article 10(4);

(c) indicate any failure to provide requested information, and whether there are any delays in providing that information by the deadline set by the Agency in accordance with Article 10(3).

Member States shall comply with the Agency’s request by the deadline set by the Agency.

Following the reporting on the results of the monitoring referred to in Article 7 and any recommendations on preventive or mitigating measures provided in accordance with Article 8(3) and (4), Member States shall:

(a) take into account any recommendations and guidelines referred to in Article 12, point (c), and coordinate their actions in relation to any actions taken at Union level pursuant to Article 12, point (a);

(b) inform the MSSG of any measures taken and report on the results of the actions referred to in point (a), including providing information on the resolution of the actual or potential shortage of medicinal products.

For the purposes of the first subparagraph, points (a) and (b), Member States that take an alternative course of action at national level shall share the reasons for doing so with the MSSG in a timely manner.