L 20/16
EN
Official Journal of the European Union
31.1.2022
6.
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 1.
For the duration of a public health emergency, or following the recognition of a major event as referred to in Article 4(3) until it has been confirmed that the major event has been sufficiently addressed pursuant to Article 4(4), the MSSG shall regularly report the results of the monitoring referred to in Article 7 to the Commission and the single points of contact referred to in Article 3(6), and, in particular, shall signal any actual or potential shortages of medicinal products included on the critical medicines lists or any event that is likely to lead to a major event.
The reports 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. 2.
Where requested by the Commission or one or more single point of contact as referred to in Article 3(6), 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