1. The EDE shall issue a decision to cancel the approval or permit issued by it to import, export or re-export the Medical Product, raw materials or pharmaceutical raw materials, in any of the following cases: a. If it is proven that obtaining approval or permit from the EDE was a result of submitting forged documents or incorrect information. b. New clinical data or new data resulting from post-marketing surveillance activities, including an increase in the number of medical events or serious adverse reactions associated with the Medical Product, which demonstrate the unsafety of the Medical Product to be imported or exported. c. Reasons for cancelling or resubmitting the Marketing Approval of all types or the Emergency Use approval issued for the Medical Product to be imported or exported in the State, as stated in Article (15) and Article (17) of this Decree-Law. d. Withdrawal or suspension of the Marketing Approval issued for the Medical Product to be imported in the State of origin, or the State of origin revoking the authorization for international export. e. Receive data proving the unsafety of the raw materials or pharmaceutical raw materials to be imported or exported. 2. The Ownership of the approval or import, export or re-export permit issued by the EDE may not be transferred to another party. In the event that the Marketing Right Holder or the importing or exporting Establishment changes, a new approval or permit for import, export or re-export shall be applied for.
Interpretation and application must be checked against the official text and current version.