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 45 of 63: Paragraphs 2617–2676

Added3.2.1.5. Reference standards or materials

Added3.2.1.6. Container and closure system of the active substance

Added3.2.1.7. Stability of the active substance(s)

Added3.2.2. Finished medicinal product

Added3.2.2.1. Description and composition of the finished medicinal product

Added3.2.2.2. Pharmaceutical development

Added3.2.2.3. Manufacturing process of the finished medicinal product

Added3.2.2.4. Control of excipients

Added3.2.2.5. Control of the finished medicinal product

Added3.2.2.6. Reference standards or materials

Added3.2.2.7. Container and closure of the finished medicinal product

Added3.2.2.8. Stability of the finished medicinal product

Added4. Module 4: Non-clinical reports

Added4.1. Format and Presentation

Added4.2. Content: basic principles and requirements

Added4.2.1. Pharmacology

Added4.2.2. Pharmaco-kinetics

Added4.2.3. Toxicology

Added5. Module 5: Clinical study reports

Added5.1. Format and Presentation

Added5.2. Content: basic principles and requirements

Added5.2.1. Reports of bio-pharmaceutics studies

Added5.2.2. Reports of studies pertinent to pharmaco-kinetics using human bio-materials

Added5.2.3. Reports of human pharmaco-kinetic studies

Added5.2.4. Reports of human pharmaco-dynamic studies

Added5.2.5. Reports of efficacy and safety studies

Added5.2.5.1. Study Reports of Controlled Clinical Studies Pertinent to the Claimed Indication

Added5.2.5.2. Study reports of uncontrolled clinical studies reports of analyses of data from more than one study and other clinical study reports

Added5.2.6. Reports of post-marketing experience

Added5.2.7. Case reports forms and individual patient listings

AddedPart II: Specific marketing authorisation dossiers and requirements

Added1. Well- established medicinal use

Added2 Essentially similar medicinal products

Added3. Additional data required in specific situations

Added4. Similar biological medicinal products

Added5. Fixed combination medicinal products

Added6. Documentation for applications in exceptional circumstances

Added7. Mixed marketing authorisation applications

AddedPart III: Particular medicinal products

Added1. Biological medicinal products

Added1.1. Plasma-derived medicinal product

Added1.2. Vaccines

Added2. Radio-pharmaceuticals and precursors

Added2.1. Radio-pharmaceuticals

Added2.2. Radio-pharmaceutical precursors for radio-labelling purposes

Added3. Homeopathic medicinal products

Added4. Herbal medicinal products

Added5. Orphan Medicinal Products

AddedPart IV: Advanced therapy medicinal products

Added1. Introduction

Added2. Definitions

Added2.1. Gene therapy medicinal product

Added2.2. Somatic cell therapy medicinal product

Added3. Specific requirements regarding Module 3

Added3.1. Specific requirements for all advanced therapy medicinal products

Added3.2. Specific requirements for gene therapy medicinal products

Added3.2.1. Introduction: finished product, active substance and starting materials

Added3.2.1.1. Gene therapy medicinal product containing recombinant nucleic acid sequence(s) or genetically modified microorganism(s) or virus(es)

Added3.2.1.2. Gene therapy medicinal product containing genetically modified cells

Added3.2.2. Specific requirements

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=45
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=45 (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=45}},
  url = {https://news.eu-parl.st-solutions.dev/texts/A-9-2024-0140/compare/TA-9-2024-0220?all=1&part=45},
  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)}
}