5 Amendments of Traian BĂSESCU related to 2020/0321(COD)
Amendment 244 #
Proposal for a regulation
Article 1 – paragraph 1 – point a
Article 1 – paragraph 1 – point a
(a) prepare for and manage the impact of major events in order to limit urgently that impact on medicinal products for human use and of public health emergencies on medicinal products for human use and on medical devices;
Amendment 249 #
Proposal for a regulation
Article 1 – paragraph 1 – point b
Article 1 – paragraph 1 – point b
(b) monitor and report on shortages of medicinal products for human use and medical devices, and adopt all adequate and necessary measures to ensure that shortages of essential medicinal products can be avoided and patients have access to safe medicinal products and treatments at accessible prices;
Amendment 259 #
Proposal for a regulation
Article 2 – paragraph 1 – point a
Article 2 – paragraph 1 – point a
(a) ‘public health emergency’ means a public health emergency at Union level rdecognislared by the European Commission in accordance with Article 23(1) of Regulation (EU) 2020/[…]17; _________________ 17[insert reference to the Regulation of the European Parliament and of the Council on serious cross-border threats to health and repealing Decision No 1082/2013/EU] OJ C […], […], p. […].
Amendment 289 #
Proposal for a regulation
Article 2 – paragraph 1 – point f
Article 2 – paragraph 1 – point f
(f) ‘major event’ means an event which is likely to pose a serious risk to public health in relation to medicinal products in more than onone or more Member State. Such an event concerns a deadly threat or otherwise serious threat to health of biological, chemical, environmental or other origin or incident that can affect the supply or quality, safety, and efficacy of medicinal products. Such an event may lead to shortages of medicinal products in more than one Member State and necessitates urgent coordination at Union level in order to ensure a high level of human health protection.
Amendment 621 #
Proposal for a regulation
Article 18 – paragraph 1 – point d a (new)
Article 18 – paragraph 1 – point d a (new)
(da) develop, implement and coordinate an online European platform where consumers, pharmacists, medical professionals and all other European citizens can report shortages of medicinal products or medical devices in any of the Member States;