31.1.2022
EN
Official Journal of the European Union
L 20/21
Article 13 European shortages monitoring platform 1.
The Agency shall set up, maintain, and manage an IT platform to be known as the European shortages monitoring platform (‘ESMP’), which shall be linked to the database referred to in Article 57(1), point (l), of Regulation (EC) No 726/2004.
The ESMP shall be used to facilitate the collection of information on shortages of, supply of, and demand for medicinal products, including information on whether the medicinal product is placed or ceases to be placed on the market in a Member State.
2.
The information collected through the ESMP shall be used to monitor, prevent, and manage:
(a) actual or potential shortages of medicinal products on the critical medicines lists during public health emergencies and major events; and (b) actual or potential shortages of medicinal products that are likely to lead to a public health emergency or a major event in accordance with Article 4(2).
3.
For the purposes of paragraph 2, during public health emergenciesand major events:
(a) marketing authorisation holders 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(2), point (a), in accordance with Articles 9 and 10; (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.
The reporting referred to in the first subparagraph, point (b), shall include information in addition to that referred to in that point received from marketing authorisation holders and wholesale distributors, or other persons or legal entities that are authorised or entitled to supply to the public medicinal products included on the critical medicines lists, where relevant. 4.
For the purposes of paragraph 2, and as regards ensuring preparedness for public health emergencies and major events: (a) marketing authorisation holders shall use the ESMP to report to the Agency: (i) the information referred to in Article 13(4) of Regulation (EC) No 726/2004 for authorisations granted in accordance with that Regulation; (ii) information based on the categories set out in Article 9(3) that relate to actual or potential shortages of medicinal products that are likely to lead to a public health emergency or major event, where appropriate; (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).
5.
The reporting referred to in paragraph 4, point (b):
(a) shall include the information referred to in Article 23a of the Directive 2001/83/EC that was reported to national competent authorities for medicinal products for authorisations granted in accordance with that Directive; (b) may include additional information received from marketing authorisation holders, wholesale distributors and other persons or legal entities that are authorised or entitled to supply medicinal products to the public.
6.
To ensure the optimal use of the ESMP, the Agency shall:
(a) develop the technical and functional specifications of the ESMP, including the data exchange mechanism for exchanging with the existing national systems and the format for electronic submissions, in collaboration with the MSSG; (b) require that data submitted to the ESMP comply with the standards developed by the International Organization for Standardization for the identification of medicinal products and be based on the domains of master data in pharmaceutical regulatory processes, namely substance, product, organisation, and referential data, where relevant;