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European marketing authorisation
for GMO-medicinal products
(Author: M. Goossens - Last revised:
February 4, 2013
)
Marketing authorisation for GMO-medicinal products for human use
Two product has received marketing authorisation under Regulation 2309/93/EEC:
Marketing authorisation for GMO-medicinal products for veterinary use
One product has been assessed and received marketing authorisation under Directive 90/220/EEC (table1).
Since the European Regulation 2309/93/EEC applies, 13 medicinal products containing genetically modified organisms have received marketing authorisation in Europe (table1). Since the publication of the Royal Decree of 18/12/98 (full text in French - in Dutch), the environmental risk has been reviewed for 9 of those products by the Belgian Biosafety Council in compliance with article 22 of the Decree. One more products has been reviewed by the Belgian Biosafety Council but the applicant has withdrawn his application.
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