# 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) (revoked)

EU Regulation No 1394/2007 · adopted 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)

## Introductory text

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) (revoked)
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## Chapter 1: SUBJECT MATTER AND DEFINITIONS

## 1 Subject matter

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## 2 Definitions

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## Chapter 2: MARKETING AUTHORISATION REQUIREMENTS

## 3 Donation, procurement and testing

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## 4 Clinical trials

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## 5 Good manufacturing practice

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## 6 Issues specific to medical devices

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## 7 Specific requirements for advanced therapy medicinal products containing devices

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## Chapter 3: MARKETING AUTHORISATION PROCEDURE

## 8 Evaluation procedure

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## 9 Combined advanced therapy medicinal products

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## Chapter 4: SUMMARY OF PRODUCT CHARACTERISTICS, LABELLING AND PACKAGE LEAFLET

## 10 Summary of product characteristics

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## 11 Labelling of outer/immediate packaging

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## 12 Special immediate packaging

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## 13 Package leaflet

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## Chapter 5: POST-AUTHORISATION REQUIREMENTS

## 14 Post-authorisation follow-up of efficacy and adverse reactions, and risk management

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## 15 Traceability

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## Chapter 6: INCENTIVES

## 16 Scientific advice

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## 17 Scientific recommendation on advanced therapy classification

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## 18 Certification of quality and non-clinical data

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## 19 Reduction of the fee for marketing authorisation

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## Chapter 7: COMMITTEE FOR ADVANCED THERAPIES

## 20 Committee for Advanced Therapies

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## 21 Composition of the Committee for Advanced Therapies

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## 22 Conflicts of interest

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## 23 Tasks of the Committee for Advanced Therapies

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## Chapter 8: GENERAL AND FINAL PROVISIONS

## 24 Amendments to the Annexes

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## 25 Report and review

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## 25a Exercise of the delegation

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## 26 Committee procedure

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## 27 Amendments to Regulation (EC) No 726/2004

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## 28 Amendments to Directive 2001/83/EC

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## 29 Transitional period

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## 30 Entry into force

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## Signature

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## Annex I Manipulations referred to in the first indent of Article 2(1)(c)

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## Annex II: Summary of product characteristics referred to in Article 10

## 1 

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## 2.1 

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## 2.2 

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## 3 

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## 4.1 

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## 4.2 

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## 4.3 

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## 4.4 

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## 4.5 

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## 4.6 

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## 4.7 

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## 4.8 

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## 4.9 

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## 5.1 

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## 5.2 

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## 5.3 

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## 6.1 

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## 6.2 

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## 6.3 

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## 6.4 

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## 6.5 

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## 6.6 

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## 7 

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## 8 

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## 9 

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## 10 

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## Annex III Labelling of outer/immediate packaging referred to in Article 11

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## Annex IV Package leaflet referred to in Article 13

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Source: https://www.legislation.gov.uk/eur/2007/1394 (the official version)
Page: https://openlegislation.uk/eu-regulation-2007-1394
Contains public sector information licensed under the Open Government Licence v3.0. Source: legislation.gov.uk, The National Archives.