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Regulation (EC) No 1394/2007 of the European Parliament and of the CouncilShow full title

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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  1. Introductory Text

  2. CHAPTER 1 SUBJECT MATTER AND DEFINITIONS

    1. Article 1.Subject matter

    2. Article 2.Definitions

  3. CHAPTER 2 MARKETING AUTHORISATION REQUIREMENTS

    1. Article 3.Donation, procurement and testing

    2. Article 4.Clinical trials

    3. Article 5.Good manufacturing practice

    4. Article 6.Issues specific to medical devices

    5. Article 7.Specific requirements for advanced therapy medicinal products containing devices

  4. CHAPTER 3 MARKETING AUTHORISATION PROCEDURE

    1. Article 8.Evaluation procedure

    2. Article 9.Combined advanced therapy medicinal products

  5. CHAPTER 4 SUMMARY OF PRODUCT CHARACTERISTICS, LABELLING AND PACKAGE LEAFLET

    1. Article 10.Summary of product characteristics

    2. Article 11.Labelling of outer/immediate packaging

    3. Article 12.Special immediate packaging

    4. Article 13.Package leaflet

  6. CHAPTER 5 POST-AUTHORISATION REQUIREMENTS

    1. Article 14.Post-authorisation follow-up of efficacy and adverse reactions, and risk management

    2. Article 15.Traceability

  7. CHAPTER 6 INCENTIVES

    1. Article 16.Scientific advice

    2. Article 17.Scientific recommendation on advanced therapy classification

    3. Article 18.Certification of quality and non-clinical data

    4. Article 19.Reduction of the fee for marketing authorisation

  8. CHAPTER 7 COMMITTEE FOR ADVANCED THERAPIES

    1. Article 20.Committee for Advanced Therapies

    2. Article 21.Composition of the Committee for Advanced Therapies

    3. Article 22.Conflicts of interest

    4. Article 23.Tasks of the Committee for Advanced Therapies

  9. CHAPTER 8 GENERAL AND FINAL PROVISIONS

    1. Article 24. Amendments to the Annexes

    2. Article 25.Report and review

    3. Article 25a. Exercise of the delegation

    4. Article 26.Committee procedure

    5. Article 27.Amendments to Regulation (EC) No 726/2004

    6. Article 28.Amendments to Directive 2001/83/EC

    7. Article 29.Transitional period

    8. Article 30.Entry into force

  10. Signature

    1. ANNEX I

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

      1. cutting, grinding, shaping, centrifugation, soaking in antibiotic or antimicrobial solutions,...

    2. ANNEX II

      Summary of product characteristics referred to in Article 10

      1. 1. Name of the medicinal product.

      2. 2. Composition of the product:

        2. 2.1. general description of the product, if necessary with explanatory drawings...

        3. 2.2. qualitative and quantitative composition in terms of the active substances...

      3. 3. Pharmaceutical form.

      4. 4. Clinical particulars:

        2. 4.1. therapeutic indications,

        3. 4.2. posology and detailed instructions for use, application, implantation or administration...

        4. 4.3. contra-indications,

        5. 4.4. special warnings and precautions for use, including any special precautions...

        6. 4.5. interaction with other medicinal products and other forms of interactions,...

        7. 4.6. use during pregnancy and lactation,

        8. 4.7. effects on ability to drive and to use machines,

        9. 4.8. undesirable effects,

        10. 4.9. overdose (symptoms, emergency procedures).

      5. 5. Pharmacological properties:

        2. 5.1. pharmacodynamic properties,

        3. 5.2. pharmacokinetic properties,

        4. 5.3. preclinical safety data.

      6. 6. Quality particulars:

        2. 6.1. list of excipients, including preservative systems,

        3. 6.2. incompatibilities,

        4. 6.3. shelf life, when necessary after reconstitution of the medicinal product...

        5. 6.4. special precautions for storage,

        6. 6.5. nature and contents of container and special equipment for use,...

        7. 6.6. special precautions and instructions for handling and disposal of a...

      7. 7. Marketing authorisation holder.

      8. 8. Marketing authorisation number(s).

      9. 9. Date of the first authorisation or renewal of the authorisation....

      10. 10. Date of revision of the text.

    3. ANNEX III

      Labelling of outer/immediate packaging referred to in Article 11

      1. The name of the medicinal product and, if appropriate, an...

    4. ANNEX IV

      Package leaflet referred to in Article 13

      1. For the identification of the advanced therapy medicinal product: the...

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