The qualified person appointed by the Marketing Right Holder shall undertake the following: 1. Providing pharmaceutical or scientific information about the marketed Medical Product to Health Establishments, ensuring its accuracy and conformity with the information approved by the EDE. 2. Inform the EDE of any change or update in the manufacturing or composition methods, the source of the active ingredients, the form, packaging, or qualitative testing methods of the Medical Product, or any new use of the Medical Product or any change, update, addition, or deletion of the uses specified within the Marketing Approval to obtain its approval, and the EDE is obligated to make available data and information about the changes after their approval in accordance with the mechanisms approved by it. 3. Comply with the provisions of the guides and standards issued by the EDE concerning pharmacovigilance, and implementation of the provisions of Clause (3) of Article (68) of this Decree-Law. 4. Follow up on post-marketing reports on the Medical Product, reports on its effectiveness, safety of use and quality during its circulation in Health Establishments in the State.
Interpretation and application must be checked against the official text and current version.