1. Conditional Marketing Approval shall be valid for one year and is renewable for similar periods if the reasons and justifications for requesting conditional Marketing Approval continue. 2. The request to renew the conditional Marketing Approval shall be submitted ninety (90) days before its expiration date. The renewal shall be made in accordance with the same terms and conditions specified for its first issuance, if the reasons and justifications for requesting the conditional Marketing Approval continue. 3. The Entity submitting the conditional Marketing Approval request may not continue to practice the activity mentioned in the conditional Marketing Approval after its expiry date and until its renewal. 4. The EDE may grant Conditional 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. 5. If the Marketing Right Holder desires to continue trading the Medical Product after the expiry of the conditional marketing approval period and the expiration of the reasons and justifications calling for its submission, he shall submit a request to obtain the Marketing Approval referred to in Article (5) of this Decree-Law.
Interpretation and application must be checked against the official text and current version.