Text · Comparison of two versions

Changes from plenary report to adopted text

A-9-2024-0140 → TA-9-2024-0220

From: A-9-2024-0140 Plenary report of 21 Mar 2024
To: TA-9-2024-0220 Adopted text of 10 Apr 2024
Changes: Not comparable
Paragraphs: +3 331 added · −358 removed · 2 changed

More facts (2)

Title (from): 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
Title (to): Union code relating to medicinal products for human use

Title (from): 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
Title (to): Union code relating to medicinal products for human use

These two texts have too little in common to be compared paragraph by paragraph (under 15 % of their paragraphs match): they are different documents rather than versions of one — for example a group’s motion and the joint text that was adopted.

Every difference

The full paragraph comparison, packaging included; long runs of unchanged paragraphs are folded. One part of the text per page.

Part 48 of 63: Paragraphs 2797–2856

Added2.7. Clinical Summary

AddedA 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.

AddedSummarised 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

Added3. MODULE 3: CHEMICAL, PHARMACEUTICAL AND BIOLOGICAL INFORMATION FOR MEDICINAL PRODUCTS CONTAINING CHEMICAL AND/OR BIOLOGICAL ACTIVE SUBSTANCES

Added3.1. Format and presentation

AddedThe general outline of Module 3 is as follows:

Added— Table of contents

Added— Body of data

Added— Active substance

AddedGeneral Information

Added— Nomenclature

Added— Structure

Added— General Properties

AddedManufacture

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

AddedCharacterisation

Added— Elucidation of Structure and other Characteristics

Added— Impurities

AddedControl of Active Substance

Added— Specification

Added— Analytical Procedures

Added— Validation of Analytical Procedures

Added— Batch Analyses

Added— Justification of Specification

AddedReference Standards or Materials

AddedContainer Closure System

AddedStability

Added— Stability Summary and Conclusions

Added— Post-approval Stability Protocol and Stability Commitment

Added— Stability Data

Added— Finished Medicinal Product

AddedDescription and Composition of the Medicinal Product

AddedPharmaceutical 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

AddedManufacture

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

Sources & citation

Where the facts on this page come from, and how to cite it.

Permalink: https://news.eu-parl.st-solutions.dev/texts/A-9-2024-0140/compare/TA-9-2024-0220?all=1&part=48
Data source: European Parliament Open Data
Licensed CC BY 4.0.
Retrieved: 1 October 2026

Cite as

European Parliament (2024). “Changes between A-9-2024-0140 and TA-9-2024-0220”. Text, 10 April 2024. from A-9-2024-0140, to TA-9-2024-0220. EU Parl Watch Research. https://news.eu-parl.st-solutions.dev/texts/A-9-2024-0140/compare/TA-9-2024-0220?all=1&part=48 (retrieved 1 October 2026). Data: European Parliament Open Data, https://data.europarl.europa.eu/ (CC BY 4.0).

BibTeX

@misc{epw-text-2024-04-10,
  author = {{European Parliament}},
  title = {{Changes between A-9-2024-0140 and TA-9-2024-0220}},
  year = {2024},
  date = {2024-04-10},
  howpublished = {\url{https://news.eu-parl.st-solutions.dev/texts/A-9-2024-0140/compare/TA-9-2024-0220?all=1&part=48}},
  url = {https://news.eu-parl.st-solutions.dev/texts/A-9-2024-0140/compare/TA-9-2024-0220?all=1&part=48},
  urldate = {2026-10-01},
  publisher = {EU Parl Watch Research},
  note = {Text. from A-9-2024-0140, to TA-9-2024-0220. Data: European Parliament Open Data (CC BY 4.0)}
}