1. The approval for Emergency Use of the Medical Product shall be valid for the term of the State of health emergency declared by the State, and until it issues another declaration stating the end of the State of emergency, unless another period is specified by the EDE. 2. The EDE may review its Emergency Use authorization and consider revoking it based on new evidence or changes in the health emergency situation. 3. The EDE may extend the validity period of the Emergency Use approval issued by it or renew it for periods determined by it if the health emergency continues and the Medical Product continues to meet the necessary standards. 4. The Entity submitting the Emergency Use approval request may not continue to practice the activity mentioned in the Emergency Use approval after its expiration date. 5. Submit 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.
Interpretation and application must be checked against the official text and current version.