1. The BOD shall issue a decision on the controls, conditions and good vigilance practices that shall be adhered to by the Marketing Rights holder, licensed Pharmaceutical Establishments and Biobanks. The EDE shall be committed to updating them periodically in accordance with new information and educating the EDEs mentioned in this Clause about them. 2. Pharmaceutical Establishments, Biobanks and Health Establishments shall operate a system for reporting the cases mentioned in Clause (3) of this Article, and issue periodic safety reports related thereto to the EDE in accordance with the controls, conditions and good vigilance practices issued by the EDE. 3. Pharmaceutical Establishments, Biobanks, Health Establishments, the Ministry, the Competent Health Authorities, their employees, and health professionals shall inform the EDE of the following: a. Any serious side effects, serious adverse events, or serious adverse reactions, whether expected or unexpected, of the Medical Product, during its circulation or through local and international Clinical Research conducted on it, as soon as possible from the date of knowledge thereof, and shall not be delayed for more than (5) five days. Reporting may be in the form of initial reports, provided that follow-up reports are submitted within a maximum of (15) fifteen days, including re-assessment of the case and after completion of the data. b. Any side effects, adverse events, or non-serious adverse reactions of the Medical Product during its circulation or through local and international Clinical Research conducted on it, within (90) ninety days of receiving the related reports, provided that the reporting is in the form of complete reports. c. Any complaint or report to withdraw a batch of the Medical Product or the entire Medical Product inside or outside the State within a period not exceeding (15) fifteen days from the date of knowledge of the complaint or report. d. Any suspicion of fraud or counterfeiting of the Medical Product or suspicion of illegal trade in Medical Products by third parties immediately from the date of knowledge thereof. e. Any defects in the quality of the Medical Product within (15) fifteen days of receiving the full reports related thereto. 4. Users of Medical Products, patients, their affiliates, and members of society as a whole shall inform the EDE directly, or inform Pharmaceutical Establishments, Health Establishments, the Ministry, or the Competent Health Authority, of any of the cases mentioned in Clause (3) of this Article, immediately from the date of becoming aware of them. 5. The EDE shall establish and manage the national electronic system to receive and document reports of the cases referred to in Clause (3) of this Article, and the related data and information received from the categories mentioned in Clauses (3-4) of this Article, and shall be committed to educating these categories about the reporting mechanism and use of the system. 6. The EDE shall determine a mechanism for documenting reports in the system referred to in Clause (5) of this Article, which may be received through the system referred to in Article (65) of this Decree-Law, or verbally or in writing outside the system by the categories mentioned in Clauses (3-4) of this Article. 7. The EDE shall investigate the reports received by it concerning the cases referred to in Clause (3) of this Article, and confirm their validity and accuracy in consultation and coordination with the relevant pharmaceutical and Health Establishments or Biobanks. To this end, it may conduct announced and unannounced inspections, take samples, and request relevant information and documents. Based on the results of the investigation, the EDE shall suspend or withdraw the Medical Product in question or take any other necessary measures or procedures to ensure that the report is not repeated.
Interpretation and application must be checked against the official text and current version.