Medical institutions to prepare preparations, should be no supply of varieties on the market. Article IV of the State Food and Drug Administration is responsible for the supervision and management of the preparation of medical institutions across the country.
Provinces, autonomous regions, municipalities directly under the Central (food) Drug Administration is responsible for the approval and supervision of medical institutions under the jurisdiction of the preparation. Article 5 The applicant of the preparation of medical institutions shall be a medical institution that holds a "license to practice in medical institutions" and obtains a "preparation license for medical institutions".
Not obtaining a "preparation license for medical institutions" or "preparation license for medical institutions" without the corresponding preparation dosage form "hospital" category of medical institutions can apply for medical institutions of traditional Chinese medicine preparations, but must be entrusted with the preparation of the application. The unit that accepts the entrusted preparation shall be the medical institution that obtains the "Preparation License for Medical Institutions" or the pharmaceutical manufacturer that obtains the certification of "Good Manufacturing Practice". The commissioned preparation formulations should be consistent with the scope of the commissioned party's "preparation license for medical institutions" or "Drug Production Quality Management Standard" certification certificate. Article VI of the medical institution preparations can only be used in the medical institution with the prescription of a licensed physician or physician assistant, and with the "medical practice license" set out in the scope of treatment. Chapter II Declaration and Approval Article 7 The application for medical institution preparations, should be carried out corresponding preclinical studies, including prescription screening, preparation process, quality indicators, pharmacology, toxicology research. Article 8 The information submitted for application for registration of preparations for medical institutions shall be true, complete and standardized. Article 9 The chemical raw materials used for the application of preparations and the implementation of the approval number management of Chinese herbal medicines and traditional Chinese medicine must have a drug approval number, and comply with the statutory drug standards. Article 10 The applicant shall apply for registration of the preparation or use of the prescription, process, use, etc., to provide the applicant or others in China's patents and their ownership of the state description; others in China the existence of patents, the applicant shall submit a statement that the patents of others do not constitute infringement. Article 11 The name of the preparation of medical institutions shall be named in accordance with the principles of drug naming promulgated by the State Food and Drug Administration, shall not use trade names. Article XII of the medical institutions to prepare preparations for the use of excipients and direct contact with the preparations of packaging materials, containers, etc., should be consistent with the State Food and Drug Administration on excipients, direct contact with the packaging materials and containers of the drug management regulations. Article XIII of the medical institution preparation instructions and packaging labels by the province, autonomous region, municipality directly under the Central Government (food) drug supervision and management department based on the information declared by the applicant, in the approval of the preparation of the application together to be approved.
The instructions and packaging labels of medical institutions should be in accordance with the State Food and Drug Administration instructions and packaging labels printed on the management of drug labels, its text, patterns shall not exceed the approved content, and need to be marked "this preparation is limited to the use of the medical institution" words. Article 14 One of the following circumstances, shall not be declared as a medical institution preparations:
(1) the market has been supplied with varieties;
(2) containing active ingredients not approved by the State Food and Drug Administration of the varieties;
(3) in addition to allergic reaction to the original biological products;
(4) traditional Chinese medicine injections;
(5) traditional Chinese medicine, chemical composition of the preparation;
(). (E) compound preparations composed of traditional Chinese medicines and chemical drugs;
(F) narcotic drugs, psychotropic drugs, toxic drugs for medical use, and radiopharmaceuticals;
(VII) other preparations that do not conform to the relevant provisions of the State. Article XV of the application for the preparation of medical institutions, the applicant shall fill out the "application form for registration of medical institutions," the location of the province, autonomous region, municipality directly under the Central Government (food) drug supervision and management department or its commissioned municipal (food) drug supervision and management agencies, submit the relevant information and the actual samples of preparations. Article XVI received the application of the province, autonomous region, municipality directly under the Central Government (food) drug supervision and management department or its commissioned municipal (food) drug supervision and management agency for the declaration of information on the form of review, to meet the requirements to be accepted; does not meet the requirements, shall be notified in writing to the applicant from the date of receipt of the application materials within five days and explain the reasons for the delay in notification since the date of receipt of the materials shall be accepted. Article XVII of provinces, autonomous regions, municipalities directly under the Central (food) drug supervision and management department or its commissioned municipal (food) drug supervision and management agencies should be in the application within 10 days of acceptance of the organization's on-site inspection, take three consecutive batches of samples for testing, notification of the designated drug testing laboratory for sample testing and technical review of quality standards. Commissioned by the municipal level (food) drug supervision and management agencies should be completed after the above work will be reviewed, inspection reports and reporting information to the provincial, autonomous regions, municipalities directly under the Central Government (food) drug supervision and management departments, and notify the applicant.