10 Amendments of Adam JARUBAS related to 2020/0321(COD)
Amendment 199 #
Proposal for a regulation
Article 9 – paragraph 1 – point c
Article 9 – paragraph 1 – point c
(c) develop streamlined electronic monitoring and reporting systems, building upon EU telematics regulatory infrastructure, SPOR, into national shortage reporting interoperable system, preventing reporting duplication, using international standards (ISO IDMP) and supporting mutual cooperation of the Agency and National Competent Authorities and via iSPOC with Marketing Authorisation Holders;
Amendment 204 #
Proposal for a regulation
Article 9 – paragraph 1 – point e
Article 9 – paragraph 1 – point e
(e) establish and maintain a list of single points of contact from marketing authorisation holders for all medicinal products for human use authorised in the Union, through the database provided for in Article 57(1)(l) of Regulation 726/2004 after updating it by including the industry single point of contacts (iSPOC) maintaining compliance with ISO IDMP;
Amendment 210 #
Proposal for a regulation
Article 9 – paragraph 3 – introductory part
Article 9 – paragraph 3 – introductory part
3. The information referred to in point (b) of paragraph 2, without duplicating information available to the Agency via collection of information submitted by industry to the national competent authority shortages systems, shall include at least:
Amendment 280 #
Proposal for a regulation
Article 18 – paragraph 1 – point d a (new)
Article 18 – paragraph 1 – point d a (new)
(d a) develop IT tools interoperable with harmonized shortages reporting systems of National Competent Authorities (NCAs) by building on the existing digital regulatory infrastructure and ongoing projects on data management and implement AI technics to among others forecast crisis development, prepare responses and proactively initiate optimisation of resources management.
Amendment 325 #
Proposal for a regulation
Article 3 – paragraph 3
Article 3 – paragraph 3
3. The Medicines Steering Group shall be chaired by the Agency. The Chair mayshall invite third parties, including representatives of medicinal product interest groups and, marketing authorisation holders to attend its meetingand other representatives of the pharmaceutical supply chain to attend its meetings and actively participate in the dialog with the authorities.
Amendment 373 #
Proposal for a regulation
Article 6 – paragraph 1
Article 6 – paragraph 1
1. Following a request for assistance referred to in Article 4(3) and after consultation of its working party, themedicinal product interest groups and supply chain stakeholders, in time adequate to the major event, Medicines Steering Group shall adopt a list of medicinal products authorised in accordance with Directive 2001/83/EC or Regulation (EC) No 726/2004 which it considers as critical during the major event (‘the major event critical medicines list ’). The list shall be updated whenever necessary until the major event has been sufficiently addressed.
Amendment 455 #
Proposal for a regulation
Article 9 – paragraph 1 – point c
Article 9 – paragraph 1 – point c
(c) develop streamlined electronic monitoring and reporting systems, building upon EU telematics regulatory infrastructure, SPOR, into national shortage reporting interoperable system, based on national harmonised data fields and definitions across Member States, preventing reporting duplication, using international standards (ISO IDMP) and supporting mutual cooperation of the Agency and national competent authorities and via iSPOC with marketing authorisation holders;
Amendment 458 #
Proposal for a regulation
Article 9 – paragraph 1 – point e
Article 9 – paragraph 1 – point e
(e) establish and maintain a list of single points of contact from marketing authorisation holders for all medicinal products for human use authorised in the Union, through the database provided for in Article 57(1)(l) of Regulation 726/2004 after updating it by including the industry single point of contacts (iSPOC)maintaining compliance with ISO IDMP;
Amendment 473 #
Proposal for a regulation
Article 9 – paragraph 3 – introductory part
Article 9 – paragraph 3 – introductory part
3. The information referred to in point (b) of paragraph 2, without duplicating information available to the Agency via collection of information submitted by industry to the national competent authority shortages systems, shall include at least:
Amendment 619 #
Proposal for a regulation
Article 18 – paragraph 1 – point d a (new)
Article 18 – paragraph 1 – point d a (new)
(da) develop IT tools interoperable with harmonized shortages reporting systems of National Competent Authorities (NCAs) by building on the existing digital regulatory infrastructure and ongoing projects on data management and implement AI technics to among others forecast crisis development, prepare responses and proactively initiate optimisation of resources management.