Search Legislation

Advanced Search

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)

Help about what version

What Version

Close

This is a legislation item that originated from the EU

After exit day there will be three versions of this legislation to consult for different purposes. The legislation.gov.uk version is the version that applies in the UK. The EU Version currently on EUR-lex is the version that currently applies in the EU i.e you may need this if you operate a business in the EU.

The web archive version is the official version of this legislation item as it stood on exit day before being published to legislation.gov.uk and any subsequent UK changes and effects applied. The web archive also captured associated case law and other language formats from EUR-Lex.

Changes to legislation:

There are outstanding changes not yet made to Regulation (EC) No 1394/2007 of the European Parliament and of the Council. Those changes will be listed when you open the content using the Table of Contents below. Any changes that have already been made to the legislation appear in the content and are referenced with annotations. Help about Changes to Legislation

Close

Changes to Legislation

Revised legislation carried on this site may not be fully up to date. Changes and effects are recorded by our editorial team in lists which can be found in the ‘Changes to Legislation’ area. Where those effects have yet to be applied to the text of the legislation by the editorial team they are also listed alongside the affected provisions when you open the content using the Table of Contents below.

View outstanding changes

Changes and effects yet to be applied to :

  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...

Back to top

Options/Help

Print Options

Close

Legislation is available in different versions:

Latest Available (revised):The latest available updated version of the legislation incorporating changes made by subsequent legislation and applied by our editorial team. Changes we have not yet applied to the text, can be found in the ‘Changes to Legislation’ area.

Original (As adopted by EU): The original version of the legislation as it stood when it was first adopted in the EU. No changes have been applied to the text.

Close

Opening Options

Different options to open legislation in order to view more content on screen at once

Close

More Resources

Access essential accompanying documents and information for this legislation item from this tab. Dependent on the legislation item being viewed this may include:

  • the original print PDF of the as adopted version that was used for the EU Official Journal
  • lists of changes made by and/or affecting this legislation item
  • all formats of all associated documents
  • correction slips
  • links to related legislation and further information resources
Close

Timeline of Changes

This timeline shows the different versions taken from EUR-Lex before exit day and during the implementation period as well as any subsequent versions created after the implementation period as a result of changes made by UK legislation.

The dates for the EU versions are taken from the document dates on EUR-Lex and may not always coincide with when the changes came into force for the document.

For any versions created after the implementation period as a result of changes made by UK legislation the date will coincide with the earliest date on which the change (e.g an insertion, a repeal or a substitution) that was applied came into force. For further information see our guide to revised legislation on Understanding Legislation.

Close

More Resources

Use this menu to access essential accompanying documents and information for this legislation item. Dependent on the legislation item being viewed this may include:

  • the original print PDF of the as adopted version that was used for the print copy
  • correction slips

Click 'View More' or select 'More Resources' tab for additional information including:

  • lists of changes made by and/or affecting this legislation item
  • confers power and blanket amendment details
  • all formats of all associated documents
  • links to related legislation and further information resources