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.

1. The EDE, in coordination with the Competent Health Authority, shall establish a National System for the circulation, tracking and coding of Medical Products from the factory to the end user. The EDE shall manage this system in a manner that achieves the following objectives:
    a. Ensuring the validity, safety and authenticity of the Medical Product circulating in the State.
    b. Reducing and reporting grey market, counterfeit, expired or illegal Medical Products.
    c. Ensuring adequate supplies of Medical Products and strengthening emergency response capacity.
    d. Protecting investments made by Pharmaceutical Establishments in the State and protecting their intellectual property in the State, including protecting pharmaceutical trademarks and their Owners.
2. The EDE makes the system available for use and reporting by the following categories in the State:
    a. The Ministry and the relevant Health Authorities.
    b. Pharmaceutical Establishments and Biobanks.
    c. Health Establishments.
    d. Practicing health professions.
    e. The federal and local authorities concerned with customs inspection.
    f. The judicial police officers mentioned in this Decree-Law. G. Patients and community members.
3. The mechanism of the system operation, data sources, controls and procedures for recording, storing, managing, using, circulating and exchanging it, making it available, and the mechanisms for linking it with the Ministry, the Competent Health Authorities, pharmaceutical and Health Establishments, Biobanks, and the relevant customs inspection authorities, and the obligations of these authorities to feed the system with any relevant data and information available to them or to their affiliated Establishments, shall be issued by a resolution of the Cabinet based on the Chairman proposal.