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Order No. 165 of March 13, 1995, on Marketing Authorization for Medicinal Products, Denmark
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Repealed Text
Year of Version
1995
Dates
Entry into force:
March 28, 1995
Adopted:
March 13, 1995
Type of Text
Implementing Rules/Regulations
Subject Matter
Undisclosed Information (Trade Secrets),
IP Regulatory Body,
Other
Notes
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
Main text(s)
Main text(s)
Danish
Bekendtgørelse om markedsføringstilladelse til lægemidler (BEK nr 165 af 13/03/1995)
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Legislation
Is repealed by (1 text(s))
Is repealed by (1 text(s))
WIPO Lex No.
DK015