Legal analysis: Management system for the use of patients' own drugs In order to strengthen the management of the use of patients' own drugs, ensure drug safety and prevent medical disputes, the management system for the use of patients' own drugs is formulated. Self-brought drugs refer to drugs brought into the medical institution by patients during hospitalization, but not supplied by the pharmacy department of the medical institution.
Legal basis: Regulations for the Implementation of the Drug Administration Law of the People's Republic of China
Article 2 To set up a preparation room, a medical institution shall apply to the health administrative department of the people's government of the province, autonomous region or municipality directly under the Central Government where it is located, and report it to the drug supervision and administration department of the people's government at the same level for examination and approval; If the pharmaceutical supervisory and administrative departments of the people's governments of provinces, autonomous regions and municipalities directly under the Central Government pass the inspection, they shall be approved and issued a Pharmaceutical Preparation License for Medical Institutions.
the health administrative departments and drug supervision and administration departments of the people's governments of provinces, autonomous regions and municipalities directly under the Central Government shall make a decision on whether to approve or not within 3 working days from the date of receiving the application.
Article 21 Where a medical institution changes the licensed items of the Pharmaceutical Preparation License for Medical Institutions, it shall, 3 days before the licensed items change, apply to the original examination and approval authority for registration of the change of the Pharmaceutical Preparation License for Medical Institutions in accordance with the provisions of Article 2 of these Regulations; Without approval, the licensing matters shall not be changed. The original examination and approval authority shall make a decision within 15 working days from the date of receiving the application.
if a medical institution adds a new dosage form or changes its preparation place, it shall, after passing the inspection by the pharmaceutical supervisory and administrative department of the local people's government of the province, autonomous region or municipality directly under the Central Government, go through the registration of change of the Pharmaceutical Preparation License of Medical Institution in accordance with the provisions of the preceding paragraph.