Corrigendum to 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 (Official Journal of the European Union L 20 of 31 January 2022)
Date: 2023-03-09
Institutions: Council of the European Union, European Parliament
Subjects: European Medicines Agency, crisis management, exchange of information, information technology, medical device, medicinal product, operation of the Institutions, public health, shortage




L_2023071EN.01003701.xml










9.3.2023   


EN


Official Journal of the European Union


L 71/37







Corrigendum to 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

(
Official Journal of the European Union L 20 of 31 January 2022
)








1.


On page 11, Article 1, point (a):




for:






‘(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 and on medical devices at Union level;’,




read:






‘(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;’.










2.


On page 14, Article 4(2):




for:


‘2.   To facilitate the monitoring referred to in paragraph 1, the national competent authorities for medicinal products, acting through the single points of contact referred to in Article 3(6), or the platform referred to in Article 13 (the ‘ESMP’), once it is fully functional, shall report in a timely manner to the Agency […].’,


read:


‘2.   To facilitate the monitoring referred to in paragraph 1, the national competent authorities for medicinal products, acting through the single points of contact referred to in Article 3(6), second subparagraph, or the platform referred to in Article 13 (the ‘ESMP’), once it is fully functional, shall report in a timely manner to the Agency […].’.








3.


On page 16, Article 8(1):




for:


‘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.’,


read:


‘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), second subparagraph, 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.’.








4.


On page 16, Article 8(2):




for:


‘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: […]’,


read:


‘2.   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: […]’.








5.


On page 18, Article 9(2), point (d):




for:






‘(d)


request information on medicinal products on the critical medicines lists from the single points of contact referred to in Article 3(6) 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.’,




read:






‘(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.’.










6.


On page 18, Article 10(2), second subparagraph:




for:


                  ‘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 (b), 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.’,

read:


                  ‘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.’.







7.


On page 19, Article 11(1), point (a):




for:






‘(a)


submit the set of information referred to in Article 6(4) including available and estimated data on volume of demand and demand forecasts, through the single point of contact referred to in Article 3(6) and using the reporting methods and systems established pursuant to Article 9(1), points (b) and (c), respectively;’,




read:






‘(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;’.










8.


On page 20, Article 11(3):




for:


‘3.   Where Member States have any information in addition to the information to be provided in accordance with paragraphs 1 and 2 of this Article on volumes of sales of and volumes of prescriptions for medicinal products which provides evidence of an actual or potential shortage of a medicinal product included on the critical medicines lists, including data referred to in Article 23a, third paragraph, of Directive 2001/83/EC, they shall immediately provide such information to the MSSG through their respective single points of contact referred to in Article 3(6) of this Regulation.’,


read:


‘3.   Where Member States have any information in addition to the information to be provided in accordance with paragraphs 1 and 2 of this Article on volumes of sales of and volumes of prescriptions for medicinal products which provides evidence of an actual or potential shortage of a medicinal product included on the critical medicines lists, including data referred to in Article 23a, third paragraph, of Directive 2001/83/EC, they shall immediately provide such information to the MSSG through their respective single points of contact referred to in Article 3(6), second subparagraph, of this Regulation.’.








9.


On page 21, Article 13(3), point (b):




for:






‘(b)


Member States shall use the ESMP to report information relating to medicinal products on the critical medicines lists to the Agency, through the single points of contact referred to in Article 9(1), point (d), in accordance with Articles 9 and 11.’,




read:






‘(b)


Member States shall use the ESMP to report information relating to medicinal products on the critical medicines lists to the Agency, through the single points of contact referred to in Article 3(6), second subparagraph, in accordance with Articles 9 and 11.’.










10.


On page 21, Article 13(4), point (b):




for:






‘(b)


Member States shall use the ESMP to report to the Agency on shortages of medicinal products that are likely to lead to a public health emergency or major event in accordance with Article 4(2), through the single points of contact referred to in Article 9(1), point (e).’,




read:






‘(b)


Member States shall use the ESMP to report to the Agency on shortages of medicinal products that are likely to lead to a public health emergency or major event in accordance with Article 4(2), through the single points of contact referred to in Article 3(6), second subparagraph.’.










11.


On page 28, Article 22(2):




for:


‘2.   For the purposes of Article 25(2), the MDSSG shall adopt and make publicly available the set of information referred to in Article 25(2), points (b) and (c), that is necessary to monitor the supply of and demand for medical devices included on the public health emergency critical devices list, and inform the working party referred to in Article 21(5) of that set of information.’,


read:


‘2.   For the purposes of Article 25(2), the MDSSG shall adopt and make publicly available the set of information referred to in Article 25(2), points (c) and (d), that is necessary to monitor the supply of and demand for medical devices included on the public health emergency critical devices list, and inform the working party referred to in Article 21(5) of that set of information.’.








12.


On page 28, Article 24(1):




for:


‘1.   For the duration of the public health emergency, the MDSSG shall regularly report the results of the monitoring referred to in Article 23 to the Commission and the single points of contact referred to in Article 25(2), point (a), and, in particular, shall signal any actual or potential shortages of medical devices included on the public health emergency critical devices list.’,


read:


‘1.   For the duration of the public health emergency, the MDSSG shall regularly report the results of the monitoring referred to in Article 23 to the Commission and the single points of contact referred to in Article 21(5), second subparagraph, and, in particular, shall signal any actual or potential shortages of medical devices included on the public health emergency critical devices list.’.








13.


On page 29, Article 24(5):




for:


‘5.   Where requested by the Commission, the MDSSG may coordinate measures taken by the national competent authorities for medical devices, manufacturers of medical devices, notified bodies, and other entities, as relevant, to prevent or mitigate actual or potential shortages of medical devices in the context of a public health emergency or major event.’,


read:


‘5.   Where requested by the Commission, the MDSSG may coordinate measures taken by the national competent authorities for medical devices, manufacturers of medical devices, notified bodies, and other entities, as relevant, to prevent or mitigate actual or potential shortages of medical devices in the context of a public health emergency.’.








14.


On page 31, Article 27(1), point (a):




for:






‘(a)


submit the set of information referred to in Article 22(2), including available information about needs related to the medical devices included in the public health emergency critical devices list, and available and estimated data on volume of demand and demand forecasts for those medical devices, through the respective single point of contact referred to in Article 25(2), point (a), and using the monitoring and reporting methods and systems established pursuant to Article 25(1), point (b);’,




read:






‘(a)


submit the set of information referred to in Article 25(2), point (d), including available information about needs related to the medical devices included in the public health emergency critical devices list, and available and estimated data on volume of demand and demand forecasts for those medical devices, through the respective single point of contact referred to in Article 21(5), second subparagraph, using the monitoring and reporting methods and systems established pursuant to Article 25(1), point (b);’.










15.


On page 32, Article 27(3):




for:


‘3.   Where Member States have any information in addition to the information to be provided in accordance with paragraphs 1 and 2 of this Article, which provides evidence of an actual or potential shortage of medical devices, they shall immediately provide such information to the MDSSG through their respective single point of contact referred to in Article 25(2), point (a).’,


read:


‘3.   Where Member States have any information in addition to the information to be provided in accordance with paragraphs 1 and 2 of this Article, which provides evidence of an actual or potential shortage of medical devices, they shall immediately provide such information to the MDSSG through their respective single point of contact referred to in Article 21(5), second subparagraph.’.








16.


On page 32, Article 27(4), point (b):




for:






‘(b)


take into account any recommendations referred to in Article 24(3) and any guidelines referred to in Article 28, point (b), and coordinate their actions in relation to any actions taken at Union level pursuant to Article 12, point (a);’,




read:






‘(b)


take into account any recommendations referred to in Article 24(3) and any guidelines referred to in Article 28, point (b), and coordinate their actions in relation to any actions taken at Union level pursuant to Article 28, point (a);’.