COMMISSION DIRECTIVE 2009/120/EC
of 14 September 2009
amending Directive 2001/83/EC of the European Parliament and of the Council on the Community code relating to medicinal products for human use as regards advanced therapy medicinal products
(Text with EEA relevance)
THE COMMISSION OF THE EUROPEAN COMMUNITIES,
Having regard to the Treaty establishing the European Community,
Having regard 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 (1), and in particular Article 120 thereof,
Whereas:
(1)
Medicinal products for human use may only be placed on the market if a marketing authorisation has been delivered by a competent authority on the basis of an application dossier containing the results of tests and trials carried out on the products concerned.
(2)
Annex I to Directive 2001/83/EC lays down detailed scientific and technical requirements regarding the testing of medicinal products for human use against which the quality, safety and efficacy of the medicinal product should be assessed. Those detailed scientific and technical requirements should be regularly adapted to take account of scientific and technical progress.
(3)
Due to scientific and technical progress in the field of advanced therapies, as reflected in 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 (2), it is appropriate to adapt Annex I. The definitions and detailed scientific and technical requirements for gene therapy medicinal products and somatic cell therapy medicinal products should be updated. Moreover, detailed scientific and technical requirements should be established for tissue engineered products, as well as for advanced therapy medicinal product containing devices and combined advanced therapy medicinal products.
(4)
The measures provided for in this Directive are in accordance with the opinion of the Standing Committee for Medicinal Products for Human Use,
HAS ADOPTED THIS DIRECTIVE:
Article 1
Part IV of Annex I to Directive 2001/83/EC is replaced by the text set out in the Annex to this Directive.
Article 2
1. Member States shall bring into force the laws, regulations and administrative provisions necessary to comply with this Directive by 5 April 2010 at the latest. They shall forthwith communicate to the Commission the text of those provisions and a correlation table between those provisions and this Directive.
When Member States adopt those provisions, they shall contain a reference to this Directive or be accompanied by such a reference on the occasion of their official publication. Member States shall determine how such reference is to be made.
2. Member States shall communicate to the Commission the text of the main provisions of national law which they adopt in the field covered by this Directive.
Article 3
This Directive shall enter into force on the 20th day following its publication in the Official Journal of the European Union.
Article 4
This Directive is addressed to the Member States.
Done at Brussels, 14 September 2009.