5 Amendments of Josianne CUTAJAR related to 2023/0131(COD)
Amendment 288 #
Proposal for a regulation
Article 60 – paragraph 1 – point b
Article 60 – paragraph 1 – point b
(b) are orphan medicinal products and are likely to address a high unmet medical need as referred to in Article 70(1);
Amendment 322 #
Proposal for a regulation
Article 68 – paragraph 1 – introductory part
Article 68 – paragraph 1 – introductory part
1. The orphan medicine sponsor mayshall, prior to the submission of an application for marketing authorisation, request advice from the Agency on the following:
Amendment 336 #
Proposal for a regulation
Article 70 – paragraph 1 – point a
Article 70 – paragraph 1 – point a
(a) there is no medicinal product authorised in the Union for such condition orwhere, despite medicinal products being authorised for such condition in the Union, the applicant demonstrates that the orphan medicinal product, in addition to having a significant benefit, will bring exceptional therapeutic advancement;
Amendment 339 #
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 for the relevant patient population.
Amendment 514 #
Proposal for a regulation
Article 150 – paragraph 2 – subparagraph 1
Article 150 – paragraph 2 – subparagraph 1
The Committee for Human Medicinal Products shall establish for the evaluation of specific types of medicinal products or treatments, working parties with scientific expertise in the fields of pharmaceutical quality, methodologies, non- clinical and, clinical evaluations, rare diseases and paedriatic medicine.