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.
Interpretation and application must be checked against the official text and current version.