21 Amendments of Jessica POLFJÄRD related to 2023/0131(COD)
Amendment 837 #
Proposal for a regulation
Article 40 – paragraph 1
Article 40 – paragraph 1
1. Following a request by the applicant when applying for afor a marketing authorisation, made before the marketing authorisation is granted, the Commission may, by means of implementing acts, grant a transferable data exclusivity voucher to a ‘priority antimicrobial’ referred to in paragraph 3, under the conditions referred to in paragraph 4 based on a scientific assessment by the Agency.
Amendment 846 #
Proposal for a regulation
Article 40 – paragraph 3 – subparagraph 1 – introductory part
Article 40 – paragraph 3 – subparagraph 1 – introductory part
An antimicrobial shall be considered ‘priority antimicrobial’ if preclinical and clinical data underpin a significant clinical benefit with respect to antimicrobial resistance and it has at least one of the following characteristics:;
Amendment 850 #
Proposal for a regulation
Article 40 – paragraph 3 – subparagraph 1 – point a
Article 40 – paragraph 3 – subparagraph 1 – point a
Amendment 856 #
Proposal for a regulation
Article 40 – paragraph 3 – subparagraph 1 – point b
Article 40 – paragraph 3 – subparagraph 1 – point b
Amendment 861 #
Proposal for a regulation
Article 40 – paragraph 3 – subparagraph 1 – point c
Article 40 – paragraph 3 – subparagraph 1 – point c
Amendment 868 #
Proposal for a regulation
Article 40 – paragraph 3 – subparagraph 2
Article 40 – paragraph 3 – subparagraph 2
In theits scientific assessment of the criteria referred to in the first subparagraph, and in the case of antibiotics, the Agency shall take into account the ‘WHO priority pathogens list for R&D of new antibiotics’, or an equivalent list established at Union level.
Amendment 873 #
Proposal for a regulation
Article 40 – paragraph 4 – subparagraph 1 – point b
Article 40 – paragraph 4 – subparagraph 1 – point b
(b) provide information on all publicly and direct financial support received from a body that is publicly funded or public authority located in the Union, for research related to the development of the priority antimicrobial.
Amendment 912 #
Proposal for a regulation
Article 41 – paragraph 1 – subparagraph 2
Article 41 – paragraph 1 – subparagraph 2
A voucher shall only be used once and in relation to a single centrally authorised medicinal product and only if that product is within its first fourhas at least two years of regulatory data protection remaining.
Amendment 936 #
Proposal for a regulation
Article 42 – paragraph 2
Article 42 – paragraph 2
2. The Commission may revoke the voucher prior to its transfer as referred to in Article 41(3) if a reasonable request for supply, procurement or purchase of the priority antimicrobial in the Union has not been fulfilled, where such request is in line with the predicted needs of the market of the Union and the non-fulfilment not is due to situations beyond the control of the holder to the marketing authorisation.
Amendment 953 #
Proposal for a regulation
Article 43 – paragraph 1
Article 43 – paragraph 1
This Chapter shall apply until [Note to OP: insert the date of 15 years after the date of entry into force of this Regulation] or until the date when the Commission has granted a total of 102 vouchers in accordance with this Chapter, whichever date is the earliest.
Amendment 1005 #
Proposal for a regulation
Article 60 – paragraph 1 – introductory part
Article 60 – paragraph 1 – introductory part
1. The Agency mayshall offer enhanced scientific and regulatory support, including as applicable consultation with other bodies as referred to in Articles 58 and 59 and accelerated assessment mechanisms, for certain medicinal products as well as new indications, including as an extension for the marketing authorization, that, based on preliminary evidence submitted by the developer fulfil one of the following conditions:
Amendment 1017 #
(a) are likely to address an unmet medical need as referred to in Article 83(1) of [revised Directive 2001/83/EC], including orphan medicinal products as referred to in Article 83(2);
Amendment 1021 #
Proposal for a regulation
Article 60 – paragraph 1 – point b
Article 60 – paragraph 1 – point b
Amendment 1029 #
Proposal for a regulation
Article 60 – paragraph 1 – point c
Article 60 – paragraph 1 – point c
(c) can provide an advancement in therapeutic deemed to be exeptional or are expected to be of major interest from the point of view of public health, in particular as regards therapeutic innovation, taking into account the early stage of development, or antimicrobials with any of the characteristics mentioned in Article 40(3).
Amendment 1121 #
Proposal for a regulation
Article 70
Article 70
Amendment 1163 #
Proposal for a regulation
Article 71 – paragraph 2 – point a
Article 71 – paragraph 2 – point a
(a) nintwelve years for orphan medicinal products other than those referred to in points (b) and (c);
Amendment 1187 #
(b) thirteen years for orphan medicinal products addressing a high unmet medical need as referred to in Article 70;nd that one of the following requireiments can be fullfilled:
Amendment 1189 #
Proposal for a regulation
Article 71 – paragraph 2 – point b – point i (new)
Article 71 – paragraph 2 – point b – point i (new)
i) no medicinal product in the Union are authorised for such condition;
Amendment 1190 #
Proposal for a regulation
Article 71 – paragraph 2 – point b – point ii (new)
Article 71 – paragraph 2 – point b – point ii (new)
ii) regardless if medicinal products in the Union are being authorised for such condition, the applicant can demonstrate that the orphan medicinal product (apart of having a demonstrated benifit) will contribute to exceptional advancement for therapeutic;
Amendment 1191 #
Proposal for a regulation
Article 71 – paragraph 2 – point b – point iii (new)
Article 71 – paragraph 2 – point b – point iii (new)
iii) the condition affects no more than 0,5 in 10,000 persons in the European Union when the application designated for an orphan has been submitted.
Amendment 1198 #
Proposal for a regulation
Article 71 – paragraph 2 – point c
Article 71 – paragraph 2 – point c
(c) fiseven years for orphan medicinal products which have been authorised in accordance with Article 13 of [revised Directive 2001/83/EC].