5 Amendments of Stanislav POLČÁK related to 2020/0321(COD)
Amendment 350 #
Proposal for a regulation
Article 4 – paragraph 1
Article 4 – paragraph 1
1. The Agency shall continuously monitor any event in the Union or in third countries that is likely to lead to a major event or a public health emergency.
Amendment 360 #
Proposal for a regulation
Article 4 – paragraph 3
Article 4 – paragraph 3
3. Where the Agency considers that an actual or imminent major event needs to be addressed, it shall inform the Commission and the Member States thereof. The Commission, on its own initiative or following a request from one or more Member States, or the Executive Director of the Agency may request the assistance of the Medicines Steering Group to address the major event. Where requested to do so by at least two Member States or the Executive Director of the Agency, the Commission shall request the assistance of the Steering Group.
Amendment 367 #
Proposal for a regulation
Article 5 – title
Article 5 – title
Amendment 412 #
Proposal for a regulation
Article 8 – paragraph 1
Article 8 – paragraph 1
1. For the duration of a public health emergency or following a request for assistance referred to in Article 4(3) and until it is closureonfirmed that its assistance is no longer needed under Article 4(4), the Medicines Steering Group shall regularly report the results of its monitoring to the Commission and the sub-network referred to in Article 9(2), and, in particular, signal any potential or actual shortages of medicinal products included on the critical medicines lists.
Amendment 590 #
Proposal for a regulation
Article 15 – paragraph 4
Article 15 – paragraph 4
4. TFor the purposes of this Article, the Emergency Task Force shall involve representatives of the Member State or States where an application for authorisation of a clinical trial is submitted or is intended to be submitted in the preparation of the scientific advice.