1. The EDE, Ministry or Competent Health Authority, each within the limits of their jurisdiction, shall supervise the compliance of Pharmaceutical Establishments and Biobanks with the provisions of this Decree-Law, its Executive Regulations and the decisions issued in implementation thereof, including the licensing conditions, approvals and permits issued, and for this purpose it may carry out inspections, take samples and request the necessary information and documents. 2. The EDE shall supervise and inspect shipments of Medical Products and logistics centers in ports and outlets, in all regions of the State, including free zones. To this end, it may conduct announced and unannounced inspections, take samples, and request the necessary information and documents. 3. The EDE shall carry out inspections of Pharmaceutical Establishments and Biobanks licensed by the Ministry or the Competent Health Authority, in coordination with it, and for this purpose it may take samples and request the necessary information and documents. 4. The EDE may cooperate with the Ministry and the Competent Health Authority to conduct joint monitoring of the compliance of licensed Pharmaceutical Establishments and Biobanks and to ensure the availability of sufficient stock of Medical Products therein, and it may form work teams to conduct joint monitoring.
Interpretation and application must be checked against the official text and current version.