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

Slovenia
Article 27 of the Medicinal Products and Medicinal Devices Act (published in Official Gazette Nº 101/99)
In regard to undisclosed information provisions of Article 39 of the TRIPS Agreement, the Government of Slovenia, in addition to already notified legislation, herewith notifies Article 27 of the Medicinal Products and Medicinal Devices Act (published in Official Gazette Nº 101/99). The Medicinal Products and Medicinal Devices Act replaced the Medicinal Products Act of 1996. Article 27 relates to the obligation of the respective governmental authority to keep the documentation which accompanies an application for marketing authorization as a trade secret. The translation of Article 27 reads as follows: "The documentation enclosed in the application for authorization for marketing medicinal products is the property of the applicant and a trade secret, with the exception of the summary of principal characteristics of the medicinal product and its instructions for use. The competent authority may abridge the information from a summary of product characteristics, which is necessary for informing the professional community on medicinal products." Disclosure of trade secrets is punishable under Article 266 of the Penal Code of 1994 as amended in 1999. (Published in Official Gazette Nº 63/94 and 23/99.)