rec_19

(19) A harmonised system of monitoring shortages of medicinal products and medical devices should be established. This would facilitate appropriate access to critical medicinal products and medical devices during public health emergencies and major events, which can have a serious impact on public health. That system should be complemented by improved structures for ensuring the appropriate management of public health emergencies and major events and for coordinating and providing advice on research and development relating to medicinal products which have the potential to mitigate public health emergencies or major events. In order to facilitate the monitoring and reporting of actual or potential shortages of medicinal products and medical devices, the Agency should be able to request and obtain information and data from the marketing authorisation holders concerned, manufacturers and Member States through designated single points of contact, while avoiding any duplication of the information requested and submitted. This should not interfere with the obligation on marketing authorisation holders under Article 23a of Directive 2001/83/EC of the European Parliament and of the Council Directive 2001/83/EC of the European Parliament and of the Council of 6 November 2001 on the Community code relating to medicinal products for human use (OJ L 311, 28.11.2001, p. 67). to notify a Member State when a product ceases to be placed on the market of that Member State or the obligation under Article 81 of that Directive on marketing authorisation holders and wholesale distributors to ensure appropriate and continued supplies of that medicinal product to persons and legal entities that are authorised or entitled to supply medicinal products, so that the needs of patients in the Member State in question are met.

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Source: EUR-Lex (Cellar) · retrieved 2026-11-06 · Text as adopted (Official Journal); later amendments are not incorporated in this text.