1. The EDE may issue a decision to cancel the Marketing Approval, conditional Marketing Approval, or approval for Emergency Use of a Medical Product in the State in any of the following cases: a. The locally manufactured Medical Product has not been put on the market within (2) years from the date of granting Marketing Approval without an excuse acceptable to the EDE. b. The locally manufactured Medical Product has not been put on the market within one year from the date of granting Marketing Approval without an excuse acceptable to the EDE. c. The Medical Product that has obtained Emergency Use approval or conditional Marketing Approval has not been placed on the market within (3) three months from the date of granting it without an excuse acceptable to the EDE. d. The unavailability or absence of the Medical Product in the market for (2) consecutive years after its introduction to the market without an excuse acceptable to the EDE. e. If it is proven that Marketing Approval of any kind or Emergency Use approval was obtained based on incorrect documents. f. If a decision is issued requiring a ban on the manufacture, distribution or circulation of the Medical Product in the State, the State of origin or any of the reference bodies approved by the EDE. g. If it is proven that the Medical Product Manufacturer or the contracted company for manufacturing Medical Products has repeatedly failed to apply the principles of good manufacturing practice or the principles of good storage and distribution, which affects the quality of the Medical Product. h. If the Medical Product is proven to be unsafe or unsafe, or repeatedly fails to comply with approved quality standards, when laboratory tests are conducted in the EDE quality control laboratory. i. If the Medical Product is proven to be unsafe due to new safety concerns or reports of adverse medical reactions or events that may require the Medical Product to be withdrawn. j. If a decision is issued requiring the prohibition of the activity of a Medical Products Manufacturer, a contracted company for the manufacture of Medical Products, a Medical Warehouse in the State, the Entity represented by the Marketing Office in the State of origin, or any of the reference bodies approved by the EDE. k. The Executive Regulations of this Decree-Law shall specify any other cases that require the cancellation of Marketing Approval of all types or approval for Emergency Use. 2. With the approval of the EDE, Ownership of the Marketing Approval or conditional Marketing Approval for a Medical Product may be transferred to other parties, in accordance with the terms and conditions specified in the Executive Regulations of this Decree-Law.
Interpretation and application must be checked against the official text and current version.