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1. The Executive Steering Group on Shortages and Safety of Medicinal Products (the ‘Medicine Shortages Steering Group – MSSG’) is hereby established within the Agency. 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.

2. The members of the MSSG shall consist of a representative of the Agency, a representative of the Commission and one representative appointed by each Member State. 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.

3. The MSSG shall be co-chaired by the representative of the Agency and by one of the representatives of the Member States, who shall be elected by and from among the representatives of the Member States in the MSSG. 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 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.

7. The MSSG may consult with the Committee for Medicinal Products for Veterinary Use (‘CVMP’) established by Article 56(1), point (b), of Regulation (EC) No 726/2004 whenever the MSSG deems necessary to do so, in particular, in order to deal with public health emergencies or major events related to zoonoses or diseases that only affect animals and that have or may have a major impact on human health or where the use of active substances for veterinary medicinal products may be useful in addressing the public health emergency or major event.

4. The MSSG, in coordination with the national competent authorities for medicinal products, shall facilitate appropriate communication with marketing authorisation holders or their representatives, manufacturers, other relevant actors of the supply chain for medicinal products, and representatives of healthcare professionals, of patients and consumers, with a view to receiving relevant information on actual or potential shortages of medicinal products considered to be critical during a public health emergency or a major event as provided for in Article 6.

5. The MSSG shall establish its rules of procedure, including procedures relating to the working party referred to in paragraph 6 of this Article and procedures for adoption of the critical medicines lists, sets of information and recommendations referred to in Article 8(3) and (4). 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.

6. The MSSG shall be supported in its work by a working party established in accordance with Article 9(1), point (d).