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 45 of 63: Paragraphs 2617–2676
Added:3.2.1.5. Reference standards or materials
Added:3.2.1.6. Container and closure system of the active substance
Added:3.2.1.7. Stability of the active substance(s)
Added:3.2.2. Finished medicinal product
Added:3.2.2.1. Description and composition of the finished medicinal product
Added:3.2.2.2. Pharmaceutical development
Added:3.2.2.3. Manufacturing process of the finished medicinal product
Added:3.2.2.4. Control of excipients
Added:3.2.2.5. Control of the finished medicinal product
Added:3.2.2.6. Reference standards or materials
Added:3.2.2.7. Container and closure of the finished medicinal product
Added:3.2.2.8. Stability of the finished medicinal product
Added:4. Module 4: Non-clinical reports
Added:4.1. Format and Presentation
Added:4.2. Content: basic principles and requirements
Added:4.2.1. Pharmacology
Added:4.2.2. Pharmaco-kinetics
Added:4.2.3. Toxicology
Added:5. Module 5: Clinical study reports
Added:5.1. Format and Presentation
Added:5.2. Content: basic principles and requirements
Added:5.2.1. Reports of bio-pharmaceutics studies
Added:5.2.2. Reports of studies pertinent to pharmaco-kinetics using human bio-materials
Added:5.2.3. Reports of human pharmaco-kinetic studies
Added:5.2.4. Reports of human pharmaco-dynamic studies
Added:5.2.5. Reports of efficacy and safety studies
Added:5.2.5.1. Study Reports of Controlled Clinical Studies Pertinent to the Claimed Indication
Added:5.2.5.2. Study reports of uncontrolled clinical studies reports of analyses of data from more than one study and other clinical study reports
Added:5.2.6. Reports of post-marketing experience
Added:5.2.7. Case reports forms and individual patient listings
Added:Part II: Specific marketing authorisation dossiers and requirements
Added:1. Well- established medicinal use
Added:2 Essentially similar medicinal products
Added:3. Additional data required in specific situations
Added:4. Similar biological medicinal products
Added:5. Fixed combination medicinal products
Added:6. Documentation for applications in exceptional circumstances
Added:7. Mixed marketing authorisation applications
Added:Part III: Particular medicinal products
Added:1. Biological medicinal products
Added:1.1. Plasma-derived medicinal product
Added:1.2. Vaccines
Added:2. Radio-pharmaceuticals and precursors
Added:2.1. Radio-pharmaceuticals
Added:2.2. Radio-pharmaceutical precursors for radio-labelling purposes
Added:3. Homeopathic medicinal products
Added:4. Herbal medicinal products
Added:5. Orphan Medicinal Products
Added:Part IV: Advanced therapy medicinal products
Added:1. Introduction
Added:2. Definitions
Added:2.1. Gene therapy medicinal product
Added:2.2. Somatic cell therapy medicinal product
Added:3. Specific requirements regarding Module 3
Added:3.1. Specific requirements for all advanced therapy medicinal products
Added:3.2. Specific requirements for gene therapy medicinal products
Added:3.2.1. Introduction: finished product, active substance and starting materials
Added:3.2.1.1. Gene therapy medicinal product containing recombinant nucleic acid sequence(s) or genetically modified microorganism(s) or virus(es)
Added:3.2.1.2. Gene therapy medicinal product containing genetically modified cells
Added:3.2.2. Specific requirements