Activities of Sara CERDAS related to 2020/0321(COD)
Plenary speeches (1)
European Medicines Agency (continuation of debate)
Amendments (11)
Amendment 246 #
Proposal for a regulation
Article 1 – paragraph 1 – point a
Article 1 – paragraph 1 – point a
(a) prevent, prepare for and manage the impact of major events on medicinal products for human use and of public health emergencies on medicinal products for human use and on medical devices;
Amendment 277 #
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 demand for that medicinal product or medical device, regardless the cause;
Amendment 293 #
Proposal for a regulation
Article 2 – paragraph 1 – point f a (new)
Article 2 – paragraph 1 – point f a (new)
(fa) ‘demand’ relates to the request for a medicinal product or a medical device by a healthcare professional or patient in response to a clinical need. For demand to be satisfactorily met, the medicinal product will need to be acquired in time and sufficient quantity to allow continuity of best care of patients.
Amendment 321 #
Proposal for a regulation
Article 3 – paragraph 3
Article 3 – paragraph 3
3. The Medicines Steering Group shall be chaired by the Agency. TAll members of the Medicines Steering Group may propose to the Chair mayto invite third parties, including representatives of medicinal product interest groups and marketing authorisation holders to attend its meetings, representatives of healthcare professionals, patients and consumers, and marketing authorisation holders to attend its meetings when their contribution may inform the discussions of the Steering Group.
Amendment 424 #
Proposal for a regulation
Article 8 – paragraph 3
Article 8 – paragraph 3
3. As part of that reporting, the Medicines Steering Group may also provide recommendations on measures, which may be taken by the Commission, Member States, marketing authorisation holders and other entities, including healthcare professionals and patients, to prevent or mitigate potential or actual shortages. In that regard the Group shall liaise, as relevant, with the Health Security Committee and, in the case of a public health emergency, the Advisory Committee on public health emergencies.
Amendment 432 #
Proposal for a regulation
Article 8 – paragraph 5
Article 8 – paragraph 5
5. The Medicines Steering Group may upon request from the Commission coordinate measures, where relevant, between the national competent authorities, the marketing authorisation holders and other entities, including healthcare professionals and patients, to prevent or mitigate potential or actual shortages in the context of a major event or public health emergency.
Amendment 482 #
Proposal for a regulation
Article 9 – paragraph 3 – point g
Article 9 – paragraph 3 – point g
(g) prevention and mitigation plans including information on production and supply capacity; production sites of the finished pharmaceutical product and of active pharmaceutical ingredients, potential alternative production sites, minimum stock levels, etc.
Amendment 489 #
Proposal for a regulation
Article 9 – paragraph 3 – point h
Article 9 – paragraph 3 – point h
Amendment 539 #
Proposal for a regulation
Article 12 – paragraph 1 – point b
Article 12 – paragraph 1 – point b
(b) consider the need for guidelines addressed to Member States, marketing authorisation holders, and other entities, including healthcare professionals to support them in their work and in the communication with patients;
Amendment 579 #
Proposal for a regulation
Article 14 – paragraph 5
Article 14 – paragraph 5
5. The Chair may invite representatives of Member States, members of scientific committees of the Agency and working parties, and third parties, including representatives of medicinal product interest groups, marketing authorisation holders, developers of medicinal products, clinical trial sponsors, representatives of clinical trial networks, independent clinical trial experts and researchers, and interest groups representing patients and healthcare professionals to attend its meetings.
Amendment 700 #
Proposal for a regulation
Article 26 – paragraph 1 – point a
Article 26 – paragraph 1 – point a
(a) take all necessary action within the limits of the powers conferred on it, with a view to mitigating potential or actual shortages of medical devices included on the public health emergency critical devices list, including, where necessary, granting temporary exemptions at Union level pursuant to Article 59(3) of Regulation (EU) 2017/745 or Article 54(3) of Regulation (EU) 2017/746, while at the same time ensuring both patient and product safety;