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Regulation (EC) No 1394/2007 of the European Parliament and of the Council of 13 November 2007
On advanced therapy medicinal products
and amending Directive 2001/83/EC and Regulation (EC) No 726/2004 (Text with EEA relevance)- Recitals
CHAPTER 1 — SUBJECT MATTER AND DEFINITIONS- CHAPTER 2 — MARKETING AUTHORISATION REQUIREMENTS
- CHAPTER 3 — MARKETING AUTHORISATION PROCEDURE
- CHAPTER 4 — SUMMARY OF PRODUCT CHARACTERISTICS, LABELLING AND PACKAGE LEAFLET
- CHAPTER 5 — POST-AUTHORISATION REQUIREMENTS
- CHAPTER 6 — INCENTIVES
- CHAPTER 7 — COMMITTEE FOR ADVANCED THERAPIES
- CHAPTER 8 — GENERAL AND FINAL PROVISIONS
- Article 24 — Amendments to the Annexes
- Article 25 — Report and review
- Article 25a — Exercise of the delegation
- Article 26 — Committee procedure
- Article 27 — Amendments to Regulation (EC) No 726/2004
- Article 28 — Amendments to Directive 2001/83/EC
- Article 29 — Transitional period
- Article 30 — Entry into force
- Final
- ANNEX I — Manipulations referred to in the first indent of Article 2(1)(c)
- ANNEX II — Summary of product characteristics referred to in Article 10
- ANNEX III — Labelling of outer/immediate packaging referred to in Article 11
- ANNEX IV — Package leaflet referred to in Article 13