1. By 31 December 2026, and every fourth year thereafter, the Commission shall present a report to the European Parliament and the Council on the application of this Regulation. In particular, that report shall review:
(a)
the crisis preparedness and management framework for medicinal products and medical devices, including the outcomes of periodic stress tests;
(b)
instances of non-compliance with the obligations set out in Articles 10 and 26 by marketing authorisation holders, manufacturers of medical devices, authorised representatives, importers, distributors and notified bodies;
(c)
the remit and functioning of the ESMP.
2. Notwithstanding paragraph 1, following a public health emergency or a major event, the Commission shall present, in a timely manner, a report to the European Parliament and the Council on the instances referred to in paragraph 1, point (b).
3. Based on the report referred to in paragraph 1, the Commission shall, where appropriate, present a legislative proposal in order to amend this Regulation. In particular, the Commission shall consider the need for:
(a)
extending the scope of this Regulation to veterinary medicinal products and to personal protective equipment for medical use;
(b)
amending Article 2;
(c)
introducing measures to strengthen at Union or national level compliance with the obligations established in Articles 10 and 26; and
(d)
expanding the remit of the ESMP, the need for further facilitating the ESMP interoperability with national and Union IT systems, the need for national shortage monitoring platforms, and the need for meeting any additional requirements to address structural shortages of medicinal products that may be introduced in the context of a revision of Directive 2001/83/EC and Regulation (EC) No 726/2004.