Order on Marketing Authorization for Medicinal Products

Year of Version:1995
Date of Entry into Force:March 28, 1995
Date of Text (Issued):March 13, 1995
Type of Text:Implementing Rules/Regulations
Subject Matter:Undisclosed Information (Trade Secrets)
The notification by Denmark to the WTO under Article 63.2 of TRIPS states:
'The order stipulates that an applicant for a marketing authorization for a medicinal product shall not be required to provide the results of toxicological and pharmacological tests and clinical trials if he can demonstrate that the medicinal product is essentially similar to a product which has been authorized within the Community, in accordance with Community provisions in force, for not less than six years and is marketed in the Member State for which the application is made.'
Available Texts: 

Bekendtgørelse om markedsføringstilladelse til lægemidler Bekendtgørelse om markedsføringstilladelse til lægemidler, Complete document (pdf) [324 KB]

WIPO Lex No.:DK015