4 Amendments of Cindy FRANSSEN related to 2023/0131(COD)
Amendment 1013 #
Proposal for a regulation
Article 60 – paragraph 1 – introductory part
Article 60 – paragraph 1 – introductory part
1. The Agency may 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 that, based on preliminary evidence submitted by the developer fulfil any of the following conditions:
Amendment 1108 #
Proposal for a regulation
Article 68 – paragraph 2
Article 68 – paragraph 2
2. Medicinal products designated as orphan medicinal products under the provisions of this Regulation shall be eligible for incentives made available by the Union and by the Member States to support research into, and the development and availability of, orphan medicinal products and in particular aid for research for small- and medium-sized undertakings and not-for-profit entities provided for in framework programmes for research and technological development.
Amendment 1139 #
Proposal for a regulation
Article 70 – paragraph 1 – point b
Article 70 – paragraph 1 – point b
(b) the use of the orphan medicinal product results in a meaningful reduction in disease morbidity or mortality or in a meaningful positive impact on quality of life for the relevant patient population.
Amendment 1624 #
Proposal for a regulation
Article 125 – paragraph 1 – point f
Article 125 – paragraph 1 – point f
(f) inform the Agency of the causes and of the end date of the critical shortage.