1. The Marketing Approval for the Medical Product is issued by the EDE in accordance with the following conditions: a. The Applicant shall be a Pharmaceutical Establishment licensed as a Marketing Office, a Medical Products Manufacturer, a contracted Medical Products manufacturing company, or a Medical Warehouse designated by the Marketing Rights holder. b. The Applicant shall implement a quality assurance and product traceability system, a pharmacovigilance system and post-marketing follow-up. c. Assessing the Medical Product compliance with the Marketing Approvals issued for it by the reference countries or its compliance with research information that proves its effectiveness, safety of use, and conformity with approved quality specifications, including the results of clinical assessment or Bioequivalence and post-marketing results to prove the safety and effectiveness of the Medical Product. d. The presence of a certificate of analysis for Medical Products in Pharmaceutical Form or a quality certificate for their batches proving their quality or safety from a laboratory licensed by the EDE or approved by it. e. The Applicant has the right to market it in accordance with the established rules for intellectual property and trademarks. If the Medical Product is similar, the Applicant shall ensure compliance with the applicable laws and regulations concerning the protection of intellectual property and trademarks and provide evidence of the use of information and data for innovative products. f. Submit a valid Good Manufacturing Practice Certificate from the EDE and/or from the Competent Authority in the State of origin and/or any of the reference bodies accredited by the EDE. g. All information and data on the Medical Product and how to use it are provided on the internal and external card and the paper or electronic leaflet for the Medical Product, and the product meets the labelling guidelines issued by the EDE. h. Any other conditions determined by the Executive Regulation of this Decree-Law. 2. Without prejudice to the provisions of international agreements to which the State is a party, and to the provisions of the intellectual property legislation in force in this regard, the EDE may grant Marketing Approval for a similar product, based on its biological and qualitative equivalence with a Pharmaceutical Product for which the legal protection granted has ceased, and for which Marketing Approval has previously been issued in accordance with the provisions of this Decree-Law. 3. The EDE shall record the Medical Product for which Marketing Approval has been issued in the database referred to in Article (66) of this Decree-Law. 4. The Executive Regulations of this Decree-Law shall specify the conditions, requirements and other controls for granting Marketing Approval, classified in accordance with the type of Medical Product and whether it is a similar, innovative, pioneering or orphan Pharmaceutical Product.
Interpretation and application must be checked against the official text and current version.