rec_58

(58) One of the aims of this Regulation is to ensure a strengthened framework for monitoring of and reporting on shortages of medicinal products during public health emergencies and major events. As announced in the communication of the Commission of 25 November 2020 entitled ‘Pharmaceutical Strategy for Europe’, the Commission will propose to revise the pharmaceutical legislation to enhance the security of supply and address shortages of medicinal products through specific measures. That legislation could cover a further coordinating role for the Agency in monitoring and managing shortages of medicinal products. If, as a result of that revision, strengthened measures regarding monitoring of and reporting on supply of and demand for medicinal products at Union level are required, the ESMP should be considered as a suitable system to facilitate any new provisions relating to monitoring of and reporting on shortages of medicinal products. As part of the reporting on this Regulation, the Commission should consider the need to extend the scope of this Regulation to include veterinary medicinal products and personal protective equipment, to amend definitions and to introduce measures at Union or national level to strengthen compliance with the obligations set out in this Regulation. That review should include consideration of the remit and functioning of the ESMP. The extension of the functioning of the ESMP and the need for national shortages monitoring systems should be considered if necessary. In order to prepare for shortages of medicinal products during public health emergencies and major events and to support the monitoring of such shortages, capacity building that is supported by Union funding mechanisms should be considered in order to enhance cooperation among Member States. This could include the exploration of best practices and the coordination of the development of IT tools for monitoring and managing shortages of medicinal products in Member States and for connecting to the ESMP. To ensure that the ESMP is used to its full potential and to identify and forecast problems relating to supply of and demand for medicinal products, where appropriate, the ESMP should facilitate the use of big data techniques and artificial intelligence.

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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.