10.12.2007 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 EURO- PEAN UNION, Having regard to the Treaty establishing the European Commu- nity, 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 (%), Whereas: (1)  New scientific progress in cellular and molecular biotech- nology has led to the development of advanced therapies, such as gene therapy, somatic cell therapy, and tissue engi- neering. This nascent field of biomedicine offers new opportunities for the treatment of diseases and dysfunc- tions of the human body. (2)  Insofar as advanced therapy products are presented as hav- ing 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 modi- fying physiological functions by exerting principally a pharmacological, immunological or metabolic action, they are biological medicinal products within the meaning of Annex [ to Directive 2001/83/EC of the European Parlia- ment and of the Council of 6 November 2001 on the Community code relating to medicinal products for human use (%), read in conjunction with the definition of medici- nal 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 (1) 0] C 309, 16.12.2006, p. 15. (?) Opinion of the European Parliament of 25 April 2007 (not yet pub- lished in the Official Journal) and Council Decision of 30 October 2007. (*) OJL311,28.11.2001, p. 67. Directive as last amended by Regulation (EC) No 1901/2006 (O] L 378, 27.12.2006, p. 1). 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 tis- sues, 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. According to Directive 2001/83/EC and the Medical Device Directives the basis for deciding which regulatory regime is applicable to combinations of medicinal prod- ucts and medical devices is the principal mode of action of the combination product. However, the complexity of combined advanced therapy medicinal products contain- ing 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 prin- cipal mode of action of the combination product. Such combination products should always be regulated under this Regulation. Because of the novelty, complexity and technical specific- ity of advanced therapy medicinal products, specially tai- lored 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 bio- technology sector. This Regulation is a lex specialis, which introduces addi- tional 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 or manufactured by a method involving an industrial process, in accordance with the general scope of the Community pharmaceutical legisla- tion laid down in Title II of Directive 2001/83/EC. Advanced therapy medicinal products which are prepared on a non-routine basis according to specific quality stan- dards, and used within the same Member State in a hospi- tal under the exclusive professional responsibility of a medical practitioner, in order to comply with an individual medical prescription for a custom-made product for an individual patient, should be excluded from the scope of this Regulation whilst at the same time ensuring that rel- evant Community rules related to quality and safety are not undermined.