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Danish guidelines on importers/manufacturers:

This article was originally published in Clinica

Executive Summary

The Danish Medicines Agency has published guidelines that clarify when an importer becomes a manufacturer, the Danish manufacturers association MedicoIndustrien reports. These guidelines reflect EU policy, so that if an importer or parallel distributor were to move into the manufacturer's field of responsibility, for example by modifying a product of its packing, they would assume full responsibility as the manufacturer. If however, changes involve inserting a Danish translation of the manufacturer's original instructions for use, or adding an additional label to the package to conform to the Danish language requirements, then the importer or distributor would not be regarded as taking on the manufacturer's responsibilities. For further information see: http://www.medicinskudstyr.dk/1024/visNyhed.mu.asp?artikelID=5692

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