8 Amendments of Pernille WEISS related to 2020/0321(COD)
Amendment 270 #
Proposal for a regulation
Article 2 – paragraph 1 – point d
Article 2 – paragraph 1 – point d
(d) ‘shortage’ means that supply of a medicinal product for human use or a medical device does not meet patients' demand for that medicinal product or medical device at national level for a period of more than two weeks;
Amendment 283 #
Proposal for a regulation
Article 2 – paragraph 1 – point e
Article 2 – paragraph 1 – point e
(e) ‘developer’ means any legal or natural person holding intellectual property rights for a medicinal product who is seeking to generate scientific data with regard to the quality, safety and efficacy of athat medicinal product as part of thate product’s development;
Amendment 287 #
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 one 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 demand, quality, safety, and efficacy of medicinal products. Such an event may lead to shortages of critical 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 387 #
Proposal for a regulation
Article 6 – paragraph 4
Article 6 – paragraph 4
4. The Agency shall immediately publishMember State representatives and the European Commission shall on a confidential basis be granted access to the critical medicines lists and any updates to those lists on itsvia the web-portal referred to in Article 26 of Regulation (EC) No 726/2004.
Amendment 427 #
Proposal for a regulation
Article 8 – paragraph 4
Article 8 – paragraph 4
4. The Medicines Steering Group may, on its own initiative or upon request from the Commission, provide recommendations on measures, which may be taken by the Commission, Member States, marketing authorisation holders and other entities to ensure preparedness to deal with potential or actual shortages of medicinal products caused by public health emergencies or major events. These recommendations may include measures to minimize unnecessary administrative burdens or facilitate flexible supply chains.
Amendment 472 #
Proposal for a regulation
Article 9 – paragraph 3 – introductory part
Article 9 – paragraph 3 – introductory part
3. The scope of the information referred to in point (b) of paragraph 2 shall include at leastbe discussed with representatives of the relevant marketing authorisation holders, including to avoid overlaps with information already submitted following Directive 2001/83/EC. Requested information may include:
Amendment 478 #
Proposal for a regulation
Article 9 – paragraph 3 – point f
Article 9 – paragraph 3 – point f
(f) details of available alternative medicinal products where known by the marketing authorisation holder;
Amendment 487 #
Proposal for a regulation
Article 9 – paragraph 3 – point g
Article 9 – paragraph 3 – point g
(g) mitigation plans including production and supply capacity;