FantasticSearch

1. This Regulation shall apply to public health measures in relation to the following categories of serious cross-border threats to health:

(a) threats of biological origin, consisting of:

(i) communicable diseases, including those of zoonotic origin;

(ii) antimicrobial resistance and healthcare-associated infections related to communicable diseases (‘related special health issues’);

(iii) biotoxins or other harmful biological agents not related to communicable diseases;

(b) threats of chemical origin;

(c) threats of environmental origin, including those due to the climate;

(d) threats of unknown origin; and (e) events which may constitute public health emergencies of international concern under the International Health Regulations (IHR) (‘public health emergencies of international concern’), provided that they fall under one of the categories of threats set out in points (a) to (d).

2. This Regulation shall also apply to the epidemiological surveillance of communicable diseases and of related special health issues.

3. The provisions of this Regulation are without prejudice to provisions of other Union acts governing specific aspects of monitoring and early warning of serious cross-border threats to health, and the coordination of prevention, preparedness and response planning for, and the coordination of combatting, serious cross-border threats to health, including measures setting quality and safety standards for specific goods and measures concerning specific economic activities.

4. In exceptional emergency situations, a Member State or the Commission may request the coordination of response within the HSC as referred to in Article 21, for serious cross-border threats to health other than those referred to in Article 2(1), if it is considered that public health measures taken previously have proven insufficient to ensure a high level of protection of human health.

5. The Commission shall, in liaison with the Member States, ensure coordination and information exchange between the mechanisms and structures established under this Regulation and similar mechanisms and structures established at international level, Union level or under the Euratom Treaty, whose activities are relevant for prevention, preparedness and response planning for, monitoring, early warning of, and combatting serious cross-border threats to health.

6. Member States shall retain the right to maintain or introduce additional arrangements, procedures and measures for their national systems in the fields covered by this Regulation, including arrangements provided for in existing or future bilateral or multilateral agreements or conventions, on condition that such additional arrangements, procedures and measures do not impair the implementation of this Regulation.