Laws and Regulations under TRIPS Art. 63.2 - View details of the document

Denmark
Order concerning marketing authorization for medicinal products, No. 165/1995, in particular §9.1 (3)
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.
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