Medical Products, Pharmacy Profession and Pharmaceutical Establishments Law

Article 135 — Article (135) License Term and Renewal

Part Seven: Licence of Pharmaceutical Establishments and Biobanks · Chapter Eight: Licensing Contractual Companies for Research and Development

1. The License to open Contractual Company for Research and Development 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 Contractual Company for Research and Development activity from the date the License expires until its renewal. 4. As an exception to Clause (3) of this Article, the Competent Health Establishment or Authority, each within the limits of their jurisdiction, may grant the Contractual Company for Research and Development an additional period of (30) thirty days after the expiry date of the License to practice its activity, provided that there is a request to renew the License submitted in advance and is under process with the Competent Health Establishment or Authority, each within the limits of their jurisdiction. 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.

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