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Guideline

The following guideline can be ordered through the address listed in the "Source/Publisher"-category.
In cases in which you can order through the Internet we have established a hyperlink.

Module 1.2 Application form (May 2008)
Internet:http://ec.europa.eu/health/files/eudralex/vol-2/b/update_200805/applicformrevised_rev9_en.pdf
Origin/Publisher:European Commission Enterprise and Industry DG, BREY 13/ 092, B - 1049 Brussels (Belgium), http://ec.europa.eu/enterprise/
Content:This application form is to be used for an application for a marketing authorisation of a medicinal product for human use submitted to (a) the European Medicines Agency under the centralised procedure or (b) a Member State (as well as Iceland, Liechtenstein and Norway) under either a national, mutual recognition procedure or decentralised procedure.
Status:Revision 9
Document Type:Notice to Applicants