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Directive 2001/83/EC of the European Parliament and of the Council of 6 November 2001
On the Community code relating to medicinal products for human use
- Recitals
TITLE I — DEFINITIONS- TITLE II — SCOPE
- TITLE III — PLACING ON THE MARKET
- CHAPTER 1 — Marketing authorization
- CHAPTER 2 — Specific provisions applicable to homeopathic medicinal products
- CHAPTER 2a — Specific provisions applicable to traditional herbal medicinal products
- CHAPTER 3 — Procedures relevant to the marketing authorization
- CHAPTER 4 — Mutual recognition and decentralised procedure
- TITLE IV — MANUFACTURE AND IMPORTATION
- TITLE V — LABELLING AND PACKAGE LEAFLET
- TITLE VI — CLASSIFICATION OF MEDICINAL PRODUCTS
- TITLE VII
- TITLE VIIA — SALE AT A DISTANCE TO THE PUBLIC
- TITLE VIII — ADVERTISING
- TITLE VIIIa — INFORMATION AND ADVERTISING
- TITLE IX — PHARMACOVIGILANCE
- CHAPTER 1 — General provisions
- CHAPTER 2 — Transparency and communications
- CHAPTER 3 — Recording, reporting and assessment of pharmacovigilance data
- CHAPTER 4 — Supervision of post-authorisation safety studies
- CHAPTER 5 — Implementation, Delegation and Guidance
- TITLE X — SPECIAL PROVISIONS ON MEDICINAL PRODUCTS DERIVED FROM HUMAN BLOOD AND PLASMA
- TITLE XI — SUPERVISION AND SANCTIONS
- TITLE XII — STANDING COMMITTEE
- TITLE XIII — GENERAL PROVISIONS
- TITLE XIV — FINAL PROVISIONS
- ANNEX