Regulation 2007/1394 - Advanced therapy medicinal products

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Contents

  1. Current status
  2. Key information
  3. Key dates
  4. Legislative text
  5. Original proposal
  6. Sources and disclaimer
  7. Full version
  8. EU Monitor

1.

Current status

This regulation has been published on December 10, 2007 and entered into force on December 30, 2007.

2.

Key information

official 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
 
Legal instrument Regulation
Number legal act Regulation 2007/1394
Original proposal COM(2005)567 EN
CELEX number147 32007R1394

3.

Key dates

Document 13-11-2007
Publication in Official Journal 10-12-2007; Special edition in Croatian: Chapter 13 Volume 064,OJ L 324, 10.12.2007
Effect 30-12-2007; Entry into force Date pub. + 20 See Art 26
30-12-2008; Application See Art 30
End of validity 31-12-9999

4.

Legislative text

10.12.2007   

EN

Official Journal of the European Union

L 324/121
 

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)

THE EUROPEAN PARLIAMENT AND THE COUNCIL OF THE EUROPEAN UNION,

Having regard to the Treaty establishing the European Community, and in particular Article 95 thereof,

Having regard to the proposal from the Commission,

Having regard to the Opinion of the European Economic and Social Committee (1),

After consulting the Committee of the Regions,

Acting in accordance with the procedure laid down in Article 251 of the Treaty (2),

Whereas:

 

(1)

New scientific progress in cellular and molecular biotechnology has led to the development of advanced therapies, such as gene therapy, somatic cell therapy, and tissue engineering. This nascent field of biomedicine offers new opportunities for the treatment of diseases and dysfunctions of the human body.
 

(2)

Insofar as advanced therapy products are presented as having properties for treating or preventing diseases in human beings, or that they may be used in or administered to human beings with a view to restoring, correcting or modifying physiological functions by exerting principally a pharmacological, immunological or metabolic action, they are biological medicinal products within the meaning of Annex I to Directive 2001/83/EC of the European Parliament and of the Council of 6 November 2001 on the Community code relating to medicinal products for human use (3), read in conjunction with the definition of medicinal products in Article 1(2) thereof. Thus, the essential aim of any rules governing their production, distribution and use must be to safeguard public health.
 

(3)

For reasons of clarity, complex therapeutic products require precise legal definitions. Gene therapy medicinal products and somatic cell therapy medicinal products have been defined in Annex I to Directive 2001/83/EC, but a legal definition of tissue engineered products remains to be laid down. When products are based on viable cells or tissues, the pharmacological, immunological or metabolic action should be considered as the principal mode of action. It should also be clarified that products which do not meet the definition of a medicinal product, such as products made exclusively of non-viable materials which act primarily by physical means, cannot by definition be advanced therapy medicinal products.
 

(4)

According to Directive 2001/83/EC and the Medical Device Directives the basis for deciding which regulatory regime is applicable to combinations of medicinal products and medical devices is the principal mode of action of the combination product. However, the complexity of combined advanced therapy medicinal products containing viable cells or tissues requires a specific approach. For these products, whatever the role of the medical device, the pharmacological, immunological or metabolic action of these cells or tissues should be considered to be the principal mode of action of the combination product. Such combination products should always be regulated under this Regulation.
 

(5)

Because of the novelty, complexity and technical specificity of advanced therapy medicinal products, specially tailored and harmonised rules are needed to ensure the free movement of those products within the Community, and the effective operation of the internal market in the biotechnology sector.
 

(6)

This Regulation is a lex specialis, which introduces additional provisions to those laid down in Directive 2001/83/EC. The scope of this Regulation should be to regulate advanced therapy medicinal products which are intended to be placed on the market in Member States and either prepared industrially...


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This text has been adopted from EUR-Lex.

5.

Original proposal

 

6.

Sources and disclaimer

For further information you may want to consult the following sources that have been used to compile this dossier:

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7.

Full version

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8.

EU Monitor

The EU Monitor enables its users to keep track of the European process of lawmaking, focusing on the relevant dossiers. It automatically signals developments in your chosen topics of interest. Apologies to unregistered users, we can no longer add new users.This service will discontinue in the near future.

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    See Bock, A.K., Ibarreta, D., Rodriguez-Cerezo, E.:
     
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    Part IV of Annex I to Directive 2001/83/EC, as amended by Directive 2003/63/EC, OJ L159, 27.6.2003, p.46. See also
     
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    Part IV of Annex I to Directive 2001/83/EC, as amended by Directive 2003/63/EC, OJ L159, 27.6.2003, p.46. See also
     
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    OJ L 311, 28.11.2001, p. 67

     
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    Part IV of Annex I to Directive 2001/83/EC, as amended by Directive 2003/63/EC, OJ L159, 27.6.2003, p.46. See also
     
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    OJ L 311, 28.11.2001, p. 67

     
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    Part IV of Annex I to Directive 2001/83/EC, as amended by Directive 2003/63/EC, OJ L159, 27.6.2003, p.46. See also
     
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    Part IV of Annex I to Directive 2001/83/EC, as amended by Directive 2003/63/EC, OJ L159, 27.6.2003, p.46. See also
     
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    Part IV of Annex I to Directive 2001/83/EC, as amended by Directive 2003/63/EC, OJ L159, 27.6.2003, p.46. See also
     
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    Part IV of Annex I to Directive 2001/83/EC, as amended by Directive 2003/63/EC, OJ L159, 27.6.2003, p.46. See also
     
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    Part IV of Annex I to Directive 2001/83/EC, as amended by Directive 2003/63/EC, OJ L159, 27.6.2003, p.46. See also
     
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    Article 2(1) of Directive 2001/83/EC, as amended by Directive 2004/27/EC.

     
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    Article 14(9) of Regulation (EC) No 726/2004.

     
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    Article 14(7) and 14(8) of Regulation (EC) No 726/2004.

     
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    Part IV of Annex I to Directive 2001/83/EC, as amended by Directive 2003/63/EC, OJ L159, 27.6.2003, p.46. See also
     
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    Part IV of Annex I to Directive 2001/83/EC, as amended by Directive 2003/63/EC, OJ L159, 27.6.2003, p.46. See also
     
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    OJ L 311, 28.11.2001, p. 67

     
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    Part IV of Annex I to Directive 2001/83/EC, as amended by Directive 2003/63/EC, OJ L159, 27.6.2003, p.46. See also
     
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    OJ L 311, 28.11.2001, p. 67

     
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    See Bock, A.K., Ibarreta, D., Rodriguez-Cerezo, E.:
     
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    Part IV of Annex I to Directive 2001/83/EC, as amended by Directive 2003/63/EC, OJ L159, 27.6.2003, p.46. See also
     
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    OJ L 311, 28.11.2001, p. 67

     
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    Part IV of Annex I to Directive 2001/83/EC, as amended by Directive 2003/63/EC, OJ L159, 27.6.2003, p.46. See also
     
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    See Bock, A.K., Ibarreta, D., Rodriguez-Cerezo, E.:
     
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    OJ L 311, 28.11.2001, p. 67

     
  • 130. 
    See Bock, A.K., Ibarreta, D., Rodriguez-Cerezo, E.:
     
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    Part IV of Annex I to Directive 2001/83/EC, as amended by Directive 2003/63/EC, OJ L159, 27.6.2003, p.46. See also
     
  • 132. 
    Part IV of Annex I to Directive 2001/83/EC, as amended by Directive 2003/63/EC, OJ L159, 27.6.2003, p.46. See also
     
  • 133. 
    Part IV of Annex I to Directive 2001/83/EC, as amended by Directive 2003/63/EC, OJ L159, 27.6.2003, p.46. See also
     
  • 134. 
    Part IV of Annex I to Directive 2001/83/EC, as amended by Directive 2003/63/EC, OJ L159, 27.6.2003, p.46. See also
     
  • 135. 
    Part IV of Annex I to Directive 2001/83/EC, as amended by Directive 2003/63/EC, OJ L159, 27.6.2003, p.46. See also
     
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    OJ L 169, 12.7.1993, p. 1

     
  • 138. 
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    Part IV of Annex I to Directive 2001/83/EC, as amended by Directive 2003/63/EC, OJ L159, 27.6.2003, p.46. See also
     
  • 140. 
    See Bock, A.K., Ibarreta, D., Rodriguez-Cerezo, E.:
     
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    Part IV of Annex I to Directive 2001/83/EC, as amended by Directive 2003/63/EC, OJ L159, 27.6.2003, p.46. See also
     
  • 142. 
    OJ L035, 15.2.1995, p. 1, as amended by Council Regulation (EC) No 2743/98 of 14 December 1998, OJ L345, 19.12.98, p. 3 and by Commission Regulation (EC) No 494/2003 of 18 March 2003, OJ L73, 19.3.2003, p. 6. See also COM(2005)106.

     
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  • 144. 
    Part IV of Annex I to Directive 2001/83/EC, as amended by Directive 2003/63/EC, OJ L159, 27.6.2003, p.46. See also
     
  • 145. 
    See also Annex 7 of the EMEA 2004 Annual
     
  • 146. 
    Part IV of Annex I to Directive 2001/83/EC, as amended by Directive 2003/63/EC, OJ L159, 27.6.2003, p.46. See also
     
  • 147. 
    Deze databank van de Europese Unie biedt de mogelijkheid de actuele werkzaamheden (workflow) van de Europese instellingen (Europees Parlement, Raad, ESC, Comité van de Regio's, Europese Centrale Bank, Hof van Justitie enz.) te volgen. EURlex volgt alle voorstellen (zoals wetgevende en begrotingsdossiers) en mededelingen van de Commissie, vanaf het moment dat ze aan de Raad of het Europees Parlement worden voorgelegd.
     
  • 148. 
    EUR-lex provides an overview of the proposal, amendments, citations and legality.