Version in force , Modified +628 −123§
Amended by Regulation (EU) 2024/1860 32024R1860 on EUR-Lex (external, EUR-Lex)
dates removed: 2029-05-25, 2029-05-26
Explanation, written by a model and checked against the cited text
Paragraph 14 no longer sets the mandatory application of the coordinated assessment procedure by reference to the fixed date of 26 May 2029, and instead ties mandatory application by all Member States to a date calculated as 5 years from the publication of the notice referred to in Article 34(3) of Regulation (EU) 2017/745 confirming that the electronic system under Article 30(2), point (e), is functional.
The earlier fixed cut-off of 25 May 2029, before which the procedure applied only to Member States that had agreed to use it, is replaced with a period defined as before that new calculated date and at the earliest six months from the publication of the same notice.
Cited: Art. 74, v2 (external, EUR-Lex) · Art. 74, v1 (external, EUR-Lex)
v1 is the previous version, v2 this one.
Text from EUR-Lex, before and after
Previous version, in force 20 March 2023 02017R0746-20230320 → this version, in force 9 July 2024 02017R0746-20240709
Article 74
Coordinated assessment procedure for performance studies
1. By means of the electronic system referred to in Article 69, the sponsor of a performance study to be conducted in more than one Member State may submit, for the purpose of Article … 1,185 unchanged words … (c) of Section 2.3.2 of Part A of Annex XIII, which shall be assessed separately by each Member State concerned.
13. The Commission shall provide administrative support to the coordinating Member State in the accomplishment of its tasks under this Chapter.
14. The All Member States shall be required to apply the procedure set out in this Article shall, until 25 May 2029, from the date corresponding to 5 years from the date of publication of the notice referred to in Article 34(3) of Regulation (EU) 2017/745, informing that the electronic system referred to in Article 30(2), point (e), of this Regulation is functional and meets the functional specifications drawn up pursuant to Article 34(1) of Regulation (EU) 2017/745.
Before the date set out in the first subparagraph of this paragraph and at the earliest 6 months from the date of publication of the notice referred to in that subparagraph, the procedure set out in this Article shall be applied only by those of the Member States in which the performance studies are study is to be conducted which have agreed to apply it. From 26 May 2029, all Member States shall be required to apply that procedure.