Regulation (EC) No 1394/2007 of the European Parliament and of the Council of 13 ... (32007R1394)
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)
- 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)
- 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)
- 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
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