Without prejudice to the applicable legislation concerning intellectual property, the EDE may issue conditional Marketing Approval for the following Medical Products: 1. Orphan medical or biological products for the treatment of rare diseases that have been provisionally approved globally by some reference Health Authorities. 2. Medical Products for the treatment of life-threatening and serious diseases, the use of which results in significant therapeutic benefit, and no alternative, equivalent or authorized Medical Product is available in the State. 3. Medical Products that are not available in the State and for which there is no equivalent alternative. 4. Any other products determined by the Executive Regulations of this Decree-Law.
Interpretation and application must be checked against the official text and current version.