Council of the European Union and European Parliament 13 November 2007, 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)

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European Union · · · Cited by 3,644 · 13-11-2007

CHAPTER 1. SUBJECT MATTER AND DEFINITIONS
Article 1. Subject matter
Article 2. Definitions
CHAPTER 2. MARKETING AUTHORISATION REQUIREMENTS
Article 3. Donation, procurement and testing
Article 4. Clinical trials
Article 5. Good manufacturing practice
Article 6. Issues specific to medical devices
Article 7. Specific requirements for advanced therapy medicinal products containing devices
CHAPTER 3. MARKETING AUTHORISATION PROCEDURE
Article 8. Evaluation procedure
Article 9. Combined advanced therapy medicinal products
CHAPTER 4. SUMMARY OF PRODUCT CHARACTERISTICS, LABELLING AND PACKAGE LEAFLET
Article 10. Summary of product characteristics
Article 11. Labelling of outer/immediate packaging
Article 12. Special immediate packaging
Article 13. Package leaflet
CHAPTER 5. POST-AUTHORISATION REQUIREMENTS
Article 14. Post-authorisation follow-up of efficacy and adverse reactions, and risk management
Article 15. Traceability
CHAPTER 6. INCENTIVES
Article 16. Scientific advice
Article 17. Scientific recommendation on advanced therapy classification
Article 18. Certification of quality and non-clinical data
Article 19. Reduction of the fee for marketing authorisation
CHAPTER 7. COMMITTEE FOR ADVANCED THERAPIES
Article 20. Committee for Advanced Therapies
Article 21. Composition of the Committee for Advanced Therapies
Article 22. Conflicts of interest
Article 23. Tasks of the Committee for Advanced Therapies
CHAPTER 8. GENERAL AND FINAL PROVISIONS
Article 24. Adaptation of Annexes
Article 25. Report and review
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
ANNEX I. Manipulations referred to in the first indent of Article 2(1)(c)

10.12.2007

Official Journal of the European Union

L 324/121

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)

THE EUROPEAN PARLIAMENT AND THE COUNCIL OF THE EUROPEAN UNION,

Having regard to the

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