1. The Conditional Marketing Approval for the Medical Product is issued by the EDE in accordance with the following conditions: a. Fulfilling the conditions referred to in paragraphs (a, b, d, g) of Clause (1) of Article (6) of this Decree-Law. b. Assessing the Medical Product compliance with the Marketing Approvals issued to it by the reference countries, or providing complete information and data concerning the reasons and justifications for the Medical Product obtaining conditional Marketing Approval from the reference country or one of the global reference Health Authorities for assessment. c. Submitting an undertaking stating that the Application for the Marketing Approval referred to in Article (5) of this Decree-Law will be submitted immediately after the reasons and justifications that called for the request for conditional Marketing Approval have expired, and in the event that the Marketing Right Holder wishes to continue circulation the Medical Product after the expiry of these reasons and justifications. d. Any other conditions determined by the Executive Regulation of this Decree-Law. 2. The Conditional Marketing Approval for the Medical Product is issued by the EDE in accordance with the following controls: a. The use of Medical Products that have received conditional Marketing Approval on specific persons or groups of persons without the need to conduct Clinical Trials. b. Marketing Medical Products that have been granted conditional approval to fill the temporary shortage of a similar Medical Product licensed in the State, provided that the Medical Product is licensed in another country that has similar control over Medical Products, and there is no identical, licensed and available Medical Product in the State. c. Any other controls determined by the Executive Regulation of this Decree-Law. 3. The EDE shall record the Medical Product for which Marketing Approval has been issued in the database referred to in Article (66) of this Decree-Law.
Interpretation and application must be checked against the official text and current version.