12 Amendments of Sunčana GLAVAK related to 2023/0131(COD)
Amendment 251 #
Proposal for a regulation
Recital 33
Recital 33
(33) To optimise the functioning and efficiency of the regulatory system, the structure of the Agency’s scientific committees is simplified and reduced to two main Committees for medicinal products for human use, the Committee for Medicinal Products for Human Use (CHMP) and Pharmacovigilance Risk Assessment Committee (PRAC). and the Committee for Paediatric and Orphan Medicinal Products (CPOMP)
Amendment 1124 #
Proposal for a regulation
Article 70
Article 70
Amendment 1172 #
Proposal for a regulation
Article 71 – paragraph 2 – point a
Article 71 – paragraph 2 – point a
(a) nineTen years for orphan medicinal products other than those referred to in points (b) and (c);
Amendment 1175 #
Proposal for a regulation
Article 71 – paragraph 2 – point b
Article 71 – paragraph 2 – point b
Amendment 1303 #
Proposal for a regulation
Article 76 – paragraph 4
Article 76 – paragraph 4
4. In consultation with the Commission and with interested parties, and with the CPOMP, the Agency shall draw up and publish guidelines for the practical application of this Article.
Amendment 1306 #
Proposal for a regulation
Article 77 – paragraph 1
Article 77 – paragraph 1
1. After the validation of the proposed paediatric investigation plan referred to in Article 74(1).which is valid in accordance with the provisions of Article 76(2), the Agency shall adopt within 970 days a decision as to whether or not the proposed studies will ensure the generation of the necessary data determining the conditions in which the medicinal product may be used to treat the paediatric population or subsets thereof, and as to whether or not the expected therapeutic benefits, where appropriate also over existing treatments, justify the studies proposed. When adopting its decision, the Agency shall consider whether or not the measures proposed to adapt the pharmaceutical form, the strength, the route of administration and the eventual administration device of the medicinal product for use in different subsets of the paediatric population are appropriate.
Amendment 1317 #
Proposal for a regulation
Article 78 – paragraph 7
Article 78 – paragraph 7
7. In consultation with the Commission and with interested parties, and with the CPOMP, the Agency shall draw up and publish guidelines for the practical application of this Article.
Amendment 1326 #
Proposal for a regulation
Article 82 – paragraph 2 a (new)
Article 82 – paragraph 2 a (new)
2 a. In case of the product that has already been authorized for use in adults in accordance with the provision of this Regulation, and if the cause for deferral of the PIP was a failure to timely complete clinical studies in children, before granting another deferral, the Agency may consider the evidence obtained from extrapolation and from the appropriately designed post-marketing long-term studies for monitoring safety and efficacy as specified in Article 138, paragraph 1, subparagraph 2, point za a(new)
Amendment 1337 #
Proposal for a regulation
Article 85 – paragraph 1
Article 85 – paragraph 1
1. In consultation with the Member States, the Commission, and interested parties, the Agency and its relevant Committee (CPOMP) shall draw up the detailed arrangements concerning the format and content which applications for agreement or modification of a paediatric investigation plan, and requests for waivers or deferrals are to follow in order to be considered valid and concerning the operation of the compliance check referred to in Articles 48, 49(2), 86 and 90(2) of [revised Directive 2001/83/EC].
Amendment 1355 #
Proposal for a regulation
Article 88 – paragraph 1 a (new)
Article 88 – paragraph 1 a (new)
Where a paediatric investigation plan, agreed in accordance with the provisions of Article 77, paragraphs 1, 2 and 4 could not be completed due to failure of timely completion of pediatric studies, for the product that has already been authorized for use in adults in accordance with the provision of this Regulation, the Agency should consider evidence from the pediatric studies as specified in Article 138, paragraph 1, subparagraph 2, point za a(new)
Amendment 1361 #
Proposal for a regulation
Article 91 – paragraph 3 a (new)
Article 91 – paragraph 3 a (new)
3 a. Where a medicinal product is covered by a marketing authorization for adults, and the paediatric authorisation could not be completed due to the inability to timely complete the pediatric clinical studies, instead of granting deferrals, the Agency should consider evidence from the pediatric studies defined in Article 138, paragraph 1, subparagraph 2, point za a(new)
Amendment 1364 #
Proposal for a regulation
Article 95 – paragraph 2 a (new)
Article 95 – paragraph 2 a (new)
2 a. Within the European network, the Agency shall, together with the proposed members of the network, develop a platform study concept for paediatric patients. The objectives of the platform study concept are to create active paediatric patients’ master files open for future authorizations of the same molecules or molecules with the same mechanism of action, and/or to share the same pool of patients for joined clinical trials of industry and academia within the same administrative process.