Human Medicines Community Code Directive (Codified)

Proposal for a EUROPEAN PARLIAMENT AND COUNCIL DIRECTIVE on the Community code relating to medicinal products for human use (codified version)

Stage: In force
In force: In force since 18 Dec 2001 · CELEX 32001L0083
Procedure: Directive
Last activity: 6 Nov 2001

9 acts

Delegated and implementing acts beneath it

By status: 9 published.

Act	Kind	Status	Adoption
Commission Implementing Regulation (EU) 2025/1466	Implementing · Regulation	Published	Q2 2025
Commission Implementing Decision (EU) 2023/2484	Implementing · Decision	Published
Commission Implementing Decision (EU) 2023/172	Implementing · Decision	Published
Commission Implementing Decision (EU) 2022/146	Delegated · Regulation	Published	09/2021
Commission Delegated Regulation (EU) 2021/1686	Delegated · Regulation	Published
Commission Delegated Regulation (EU) 2021/457	Delegated · Regulation	Published
Commission Delegated Regulation (EU) 2016/161	Delegated · Regulation	Published	02/10/2015
Commission Delegated Regulation (EU) 2014/1252	Delegated · Regulation	Published	28/05/2014
Commission Delegated Regulation (EU) 2014/357	Delegated · Regulation	Published	03/02/2014

Titles link to EUR-Lex where the act has been published.

Summary

Generated

Directive 2001/83/EC codifies EU rules on medicinal products for human use, covering marketing authorization, manufacturing, distribution, pharmacovigilance, and falsified product controls. It applies to industrially prepared products, with exemptions for pharmacy-prepared and research products.

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Sources: EUR-Lex. Record as of 14 Sept 2026. Something wrong on this page? Report an error.

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