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Introductory Text
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. 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
Signature
ANNEX I
Manipulations referred to in the first indent of Article 2(1)(c)
cutting, grinding, shaping, centrifugation, soaking in antibiotic or antimicrobial solutions,...
ANNEX II
Summary of product characteristics referred to in Article 10
1. Name of the medicinal product.
2. Composition of the product:
2.1. general description of the product, if necessary with explanatory drawings...
2.2. qualitative and quantitative composition in terms of the active substances...
3. Pharmaceutical form.
4. Clinical particulars:
4.1. therapeutic indications,
4.2. posology and detailed instructions for use, application, implantation or administration...
4.3. contra-indications,
4.4. special warnings and precautions for use, including any special precautions...
4.5. interaction with other medicinal products and other forms of interactions,...
4.6. use during pregnancy and lactation,
4.7. effects on ability to drive and to use machines,
4.8. undesirable effects,
4.9. overdose (symptoms, emergency procedures).
5. Pharmacological properties:
5.1. pharmacodynamic properties,
5.2. pharmacokinetic properties,
5.3. preclinical safety data.
6. Quality particulars:
6.1. list of excipients, including preservative systems,
6.2. incompatibilities,
6.3. shelf life, when necessary after reconstitution of the medicinal product...
6.4. special precautions for storage,
6.5. nature and contents of container and special equipment for use,...
6.6. special precautions and instructions for handling and disposal of a...
7. Marketing authorisation holder.
8. Marketing authorisation number(s).
9. Date of the first authorisation or renewal of the authorisation....
10. Date of revision of the text.
ANNEX III
Labelling of outer/immediate packaging referred to in Article 11
The name of the medicinal product and, if appropriate, an...
ANNEX IV
Package leaflet referred to in Article 13
For the identification of the advanced therapy medicinal product: the...