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Regulatory framework for marketing authorisation of medicinal products containing or consisting of genetically modified organisms
(Author: M. Goossens - Last revised:
February 28, 2006
)
COUNCIL REGULATION 2309/93/EEC of 22 July1993 laying
down Community procedures for the authorisation and supervision of
medicinal products for human and veterinary use and establishing a
European Agency for the Evaluation of Medicinal Products
(OJ L 214, 24.08.1993, p.1)
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The above regulation has been replaced by:
REGULATION (EC) No 726/2004 of the European parliament and of the Council of 31 March 2004 laying down Community procedures for the authorisation and supervision of medicinal products for human and veterinary use and establishing a European Medicines Agency (OJ L 136, 30.04.2004, p.1)
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In case of a medicinal product containing or consisting of genetically modified organisms, the articles 6 and 31* of the new Regulation require from the applicant to provide the information requested by Annexes III and IV of Directive 2001/18/EC (replacing Directive 90/220/EEC) and the environmental risk assessment in accordance with the principles set out in Annex II to Directive 2001/18/EC (see the authorisation procedure below).
DIRECTIVE
2001/18/EC of the European Parliament and of the Council
of 12 March 2001 on the deliberate release into the environment of
genetically modified organisms and repealing Council Directive
90/220/EEC (OJ L 106, 17.4.2001, p.1)
*(former articles 6 and 28 of Regulation 2309/93 have not toroughly changed in the new regulation with the exception of the reference to the new Directive 2001/18/EC and its annexes)
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