1. The Marketing Approval shall be valid for a period of (5) five years, and shall be renewed for similar periods in accordance with the terms and rules governing this in the Executive Regulations of this Decree-Law. 2. The request to renew the Marketing Approval shall be submitted ninety (90) days before its expiration date. 3. The Marketing Right Holder may not continue the activity permitted in the Marketing Approval issued for the specific Medical Product after the expiry date of the Marketing Approval and until its renewal, unless the EDE deems otherwise. The EDE may authorize the Marketing Right Holder to continue the activities related to some Medical Products if necessary. 4. The EDE may grant Marketing Approval for a period less than the period referred to in Clause (1) of this Article, in accordance with the controls specified in the Executive Regulations of this Decree-Law.
Interpretation and application must be checked against the official text and current version.