Denmark
Order on Marketing Authorization for Medicinal Products
| Year of current version: | 1995 |
|---|---|
| Date of entry into force of original text: | March 28, 1995 |
| Date of Text (Issued): | March 13, 1995 |
| Type of Text: | Implementing Rules/Regulations |
| Subject Matter: | Undisclosed Information (Trade Secrets) |
| Notes: | |
| Available Texts: | |
| Danish | Bekendtgørelse om markedsføringstilladelse til lægemidler |
| WIPO Lex No.: | DK015 |
![Bekendtgørelse om markedsføringstilladelse til lægemidler, Complete document (pdf) [324 KB]](/shared/images/icon/new/pdf.gif){kind=icon}
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'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.'