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Eudralex Volume 3 GUIDELINE ON ENVIRONMENTAL RISK ASSESSMENTS FOR MEDICINAL PRODUCTS CONSISTING OF, OR CONTAINING, GENETICALLY MODIFIED ORGANISMS (GMOs)
Origin/Publisher:
European Commission Enterprise and Industry DG, BREY 13/ 092, B - 1049 Brussels (Belgium), http://ec.europa.eu/enterprise/
Document Type:
Guideline
Content:
This guideline outlines the legislative framework governing the inclusion of Environmental Risk Assessment particulars in applications for Marketing Authorisation for medicinal products consisting of, or containing, a Genetically Modified Organism. The document also provides: - An outline of the various special administrative and procedural details associated with the
applications involved. - A description of the environmental risk assessment methodology and scientific issues and data
which applicants should address in the relevant parts of the application dossiers.
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