17 Amendments of Radan KANEV related to 2020/0321(COD)
Amendment 260 #
Proposal for a regulation
Article 2 – paragraph 1 – point c a (new)
Article 2 – paragraph 1 – point c a (new)
(ca) 'supply' means total volume of stock of an individual medicinal product or medical device that is made available on the national market by a marketing authorisation holder or a manufacturer either distributors, or any other actor in the distribution chain respectively;
Amendment 264 #
Proposal for a regulation
Article 2 – paragraph 1 – point c b (new)
Article 2 – paragraph 1 – point c b (new)
(cb) 'demand' means total volume of an individual medicinal product or medical device that is requested in the national market in response to a clinical need, including the necessary buffer stock at wholesale level;
Amendment 323 #
Proposal for a regulation
Article 3 – paragraph 3
Article 3 – paragraph 3
3. The Medicines Steering Group shall be chaired by the Agency. TOn a regular basis, the Chair mayshall invite third parties, including representatives of medicinal product interest groups and marketing authorisation holders to attend its meetings. In the event of an actual or imminent major event, the Chair shall invite relevant entities from the pharmaceutical supply chain to attend its meetings.
Amendment 339 #
Proposal for a regulation
Article 3 – paragraph 6
Article 3 – paragraph 6
6. The Medicines Steering Group shall be responsible for fulfilling the tasks referred to in Article 4(3), 4 (4) and Articles 5 to 8.
Amendment 355 #
Proposal for a regulation
Article 4 – paragraph 2
Article 4 – paragraph 2
2. To facilitate the monitoring task referred to in paragraph 1, the national competent authorities, through the single points of contact referred to in Article 3(5), shall, based on the reporting criteria specified by the Agency pursuant to Article 9(1)(b), report to the Agency, in due time, in an interoperable and digitalized platform for reporting and notifying shortages, on any event, including a shortage of a medicinal product in a given Member State, that is likely to lead to a major event or a public health emergency. Where a national competent authority informs the Agency of a shortage of a medicinal product in a given Member State, it shall provide the Agency with any information received from the marketing authorisation holder pursuant to Article 23a of Directive 2001/83/EC. Based on a report of an event from a national competent authority and in order to understand the impact of the event in other Member States, the Agency may request information from the national competent authorities, through the working party referred to in Article 3(5).
Amendment 382 #
Proposal for a regulation
Article 6 – paragraph 3
Article 6 – paragraph 3
3. The Medicines Steering Group shall adopt a set of information and actions necessary to monitor the supply and demand of medicinal products included on the lists referred to in paragraphs 1 and 2 (‘the critical medicines lists’) and inform its working party thereof. The Medicines Steering Group shall report the Agency and the Commission in due time on the monitoring and shall notify immediately on any major event or shortage in the supply.
Amendment 418 #
Proposal for a regulation
Article 8 – paragraph 2
Article 8 – paragraph 2
2. Where requested by the Commission or the sub-network referred to in Article 9(2), the Medicines Steering Group shall provide aggregated data and forecasts of demand to substantiate its findings. In that regard, the Medicines Steering Group shall use data from its interoperable and digitalized platform for reporting and notifying shortages and shall liaise with the European Centre for Disease Prevention and Control to obtain epidemiological data to help forecast medicinal product needs, and with the Executive Steering Group on Shortages of Medical Devices referred to in Article 19 where medicinal products included on the critical medicines lists are administered with a medical device.
Amendment 449 #
Proposal for a regulation
Article 9 – paragraph 1 – point a
Article 9 – paragraph 1 – point a
(a) specify the procedures for establishing and reviewing the critical medicines lists;
Amendment 456 #
Proposal for a regulation
Article 9 – paragraph 1 – point c
Article 9 – paragraph 1 – point c
(c) develop streamlined electronican interoperable and digitalized platform for monitoring and, reporting systemsand notifying;
Amendment 468 #
Proposal for a regulation
Article 9 – paragraph 2 – point b
Article 9 – paragraph 2 – point b
(b) request information, including on the supply of the list of critical medicinal products, from the points of contact included in the sub-network referred to in point (a) and set a deadline for its submission in the platform;
Amendment 469 #
Proposal for a regulation
Article 9 – paragraph 2 – point c
Article 9 – paragraph 2 – point c
(c) request information, including on the supply of the list of critical medicinal products, from the single points of contact from Member States’ national competent authorities based on the set of information agreed on by the Medicines Steering Group and set a deadline for its submission in the platform.
Amendment 510 #
Proposal for a regulation
Article 10 – paragraph 4
Article 10 – paragraph 4
4. Where marketing authorisation holders for medicinal products included on the critical medicines lists indicate that the submitted information requested by the Agency and the national competent authorities contains information of a commercially confidential nature, they shall identify the relevant parts and clarify the reasons for such an indication. The Agency shall assess the merits of each request and protect commercially confidential information against unjustified disclosure.
Amendment 513 #
5. Where marketing authorisation holders for medicinal products included on the critical medicines lists and /or other relevant entities of the pharmaceutical supply chain, are in possession of any additional information, which provides evidence of a potential or actual shortage they shall immediately provide such information to the Agency.
Amendment 515 #
Proposal for a regulation
Article 10 – paragraph 6 – point c
Article 10 – paragraph 6 – point c
(c) inform the Medicines Steering Group of any measures taken and report on the monitoring and results of those measures, including information on the resolution of the potential or actual shortage.
Amendment 526 #
Proposal for a regulation
Article 11 – paragraph 1 – point a
Article 11 – paragraph 1 – point a
(a) submit the set of information requested by the Agency including available and estimated data on volume of demand, through its designated point of contact and using the reporting methods and, system and platform established pursuant to Article 9(1);
Amendment 544 #
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 from the pharmaceutical supply chain;
Amendment 612 #
Proposal for a regulation
Article 18 – paragraph 1 – point a
Article 18 – paragraph 1 – point a
(a) develop and maintain electronic tools, including an interoperable and digitalized platform, for the submission of information and data, including electronic health data generated outside the scope of clinical studies;