Changes between two versions
What changed between the plenary report and the adopted text
From · plenary report· 21 Mar 2024
on the proposal for a directive of the European Parliament and of the Council on the Union code relating to medicinal products for human use, and repealing Directive 2001/83/EC and Directive 2009/35/EC
To · adopted text· 10 Apr 2024
Union code relating to medicinal products for human use
These two texts have too little in common to compare paragraph by paragraph: they are different documents rather than versions of one (for example one group’s motion and the joint text that was adopted).
+3,331 added · −358 removed · 2 changed paragraphs, packaging included.
Part 63 of 63: Paragraphs 3697–3705
Added:(a) take into account the particular condition of certain categories of users (children, pregnant or breastfeeding women, older adults, persons with specific pathological conditions and persons with disabilities);
Added:(b) mention, if appropriate, possible effects on the ability to drive vehicles or to operate machinery;
Added:(c) list those excipients the knowledge of which is important for the safe and effective use of the medicinal product and that are included in the detailed guidance referred to in Article 77.
Added:The package leaflet may also contain information on the importance of therapeutic adherence and available support for adherence in the Member State. [Am. 338]
Added:Annex VII
Added:AREAS FOR ADAPTED FRAMEWORKS REFERRED TO IN ARTICLE 28
Added:Phage-containing medicinal products, in cases where the medicinal product has a variable composition depending on the specific clinical context.
Added:Annex VIII
Added:CORRELATION TABLE