The Applicant for Marketing Rights or his representative for marketing Medical Products shall undertake the following: 1. Appoint one or more qualified persons residing in the State, in accordance with the controls specified in the Executive Regulations of this Decree-Law. 2. Fulfil the conditions mentioned in Article (22) of this Decree-Law 3. Monitor the movement of the Medical Product in the distribution channels. 4. Provide the required capabilities and systems to follow up on the requirements for obtaining Marketing Approval, conditional Marketing Approval, Emergency Use approval, or exclusive Marketing Approval for the Medical Product. 5. Monitor the performance of the Medical Product licensed for marketing, and receiving reports from Health Establishments concerning the effectiveness, safety and quality of the product. 6. Comply with the guides and standards issued by the EDE concerning pharmacovigilance, and to implementing the provisions of Clause (3) of Article (68) of this Decree-Law. 7. Follow up on the procedures for withdrawing the Medical Product. 8. Follow up on patent protection and manufacturing rights issues for the product.
Interpretation and application must be checked against the official text and current version.