1. The License to open a Medical Product Factories and Contracting Companies Manufacture Medical Products shall be valid for a period of not less than one year, renewable. The License holder shall comply with practicing the licensed activity during the specified period of validity of the License. 2. The License Renewal Application shall be submitted sixty (60) days before its expiration date, and the renewal shall be made in accordance with the same terms and conditions specified for issuing the License for the first time. 3. The License Holder may not continue to practice the licensed Medical Product Factories and Contracting Companies Manufacture Medical Products activity from the date the License expires until its renewal. 4. As an exception to Clause (3) of this Article, the EDE may grant the Medical Product Factories and Contracting Companies Manufacture Medical Products an additional period of (30) thirty days after the expiration date of the license to practice its activity in accordance with the following conditions: a. Obtain a Valid Good Manufacturing Practice Certificate from the EDE. b. There is a previously submitted application for license renewal and it is under process with the EDE. 5. Failure to submit a License Renewal Application within ninety (90) days from the date of expiry shall result in the automatic License Cancellation and the imposition of the fine specified in the Regulations of Violations and Administrative Penalties issued for the implementation of the Decree-Law.
Interpretation and application must be checked against the official text and current version.