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 48 of 63: Paragraphs 2797–2856
Added:2.7. Clinical Summary
Added:A detailed, factual summary of the clinical information on the medicinal product included in Module 5 shall be provided. This shall include the results of all bio-pharmaceutics studies, of clinical pharmacology studies, and of clinical efficacy and safety studies. A synopsis of the individual studies is required.
Added:Summarised clinical information shall be presented in the following order:
Added:— Summary of Bio-pharmaceutics and Associated Analytical Methods
Added:— Summary of Clinical Pharmacology Studies
Added:— Summary of Clinical Efficacy
Added:— Summary of Clinical Safety
Added:— Synopses of Individual Studies
Added:3. MODULE 3: CHEMICAL, PHARMACEUTICAL AND BIOLOGICAL INFORMATION FOR MEDICINAL PRODUCTS CONTAINING CHEMICAL AND/OR BIOLOGICAL ACTIVE SUBSTANCES
Added:3.1. Format and presentation
Added:The general outline of Module 3 is as follows:
Added:— Table of contents
Added:— Body of data
Added:— Active substance
Added:General Information
Added:— Nomenclature
Added:— Structure
Added:— General Properties
Added:Manufacture
Added:— Manufacturer(s)
Added:— Description of Manufacturing Process and Process Controls
Added:— Control of Materials
Added:— Controls of Critical Steps and Intermediates
Added:— Process Validation and/or Evaluation
Added:— Manufacturing Process Development
Added:Characterisation
Added:— Elucidation of Structure and other Characteristics
Added:— Impurities
Added:Control of Active Substance
Added:— Specification
Added:— Analytical Procedures
Added:— Validation of Analytical Procedures
Added:— Batch Analyses
Added:— Justification of Specification
Added:Reference Standards or Materials
Added:Container Closure System
Added:Stability
Added:— Stability Summary and Conclusions
Added:— Post-approval Stability Protocol and Stability Commitment
Added:— Stability Data
Added:— Finished Medicinal Product
Added:Description and Composition of the Medicinal Product
Added:Pharmaceutical Development
Added:— Components of the Medicinal Product
Added:— Active Substance
Added:— Excipients
Added:— Medicinal Product
Added:— Formulation Development
Added:— Overages
Added:— Physicochemical and Biological Properties
Added:— Manufacturing Process Development
Added:— Container Closure System
Added:— Microbiological Attributes
Added:— Compatibility
Added:Manufacture
Added:— Manufacturer(s)
Added:— Batch Formula
Added:— Description of Manufacturing Process and Process Controls
Added:— Controls of Critical Steps and Intermediates
Added:— Process Validation and/or Evaluation