active substance

Pharma Directive proposal, Article 4(3) First Proposal proposed 2023-04-26

any substance or mixture of substances intended to be used in the manufacture of a medicinal product and that, when used in its production, becomes an active ingredient of that product intended to exert a pharmacological, immunological or metabolic action with a view to restoring, correcting or modifying physiological functions or to make a medical diagnosis

52025PC0102, Article 3(3) Own wording Proposal proposed 2025-03-11

any an active substance or mixture as defined in Article 4 point (3) of substances intended Directive (EU) …/… [reference to be used in the manufacture added to corresponding Article after adoption of a medicinal product and that, when used in its production, becomes an active ingredient of that product intended to exert a pharmacological, immunological or metabolic action with a view to restoring, correcting or modifying physiological functions or to make a medical diagnosis cf. COM(2023)192 final]

Compared with Pharma Directive proposal: struck words are only in Pharma Directive proposal, marked words only here.