"Drug Administration Law" Article 74 provides: "medical institutions to prepare preparations, shall be approved by the people's government of the province, autonomous region, municipality directly under the Central People's Government drug supervision and management department, to obtain the preparation of medical institutions license. No medical institution preparation license, shall not make preparations. Medical institutions preparation license shall indicate the validity of the expiration date, the expiration of the re-examination of the issuance of licenses."
Only run a department This article is the original "Drug Administration Law," Article 23 of the reservation, in the text of the deletion of "shall be subject to the location of the provincial, autonomous regions, municipalities directly under the Central People's Government of the health administrative department for examination and approval," will be "approved by the provincial, autonomous regions, municipalities directly under the Central People's Government of the drug supervision and management department. Approved by the department" was amended to "shall be approved by the drug supervision and management department of the people's government of the province, autonomous region and municipality directly under the Central Government", and deleted the book title of the preparation license of medical institutions. This amendment is mainly to remove the provincial health administrative department's power of examination and approval. This modification is convenient for the relative, before applying for medical institutions preparation license need to run two departments, now only need to run a department. August 27, 2003 "Administrative Licensing Law" promulgated, the administrative licensing behavior to regulate. Medical institutions to prepare preparations need to be approved to obtain a medical institution preparation license, belongs to the "Administrative Licensing Law," the provisions of the administrative license, while the review and approval is not an administrative license, as a precursor to administrative licensing is contrary to the provisions of the "Administrative Licensing Law". Preparations for medical institutions are medicines, a special kind of existence of medicines. Drug Administration Law, Article 8, paragraph 2, "the provincial, autonomous regions, municipalities directly under the Central People's Government drug supervision and management department is responsible for drug supervision and management work in the administrative region". Since the provincial drug supervision and management department is responsible for drug supervision in the administrative area, the approval of the preparation of medical institutions should be responsible for drug supervision and management department, and then the provisions of the competent administrative department of health examination and approval is undoubtedly redundant.
Preparation should be licensed
Medical institution preparation refers to the clinical needs of medical institutions in accordance with the unit of routine preparation, self-use of the preparation, the prescription is fixed, the preparation process is mature, and can be clinically used for a long period of time in a particular disease. The basic attributes of the preparation of the preparation is essentially a drug production activities, since it is a drug production activities, should be approved by the license. Unlike general drug production activities, the preparation of medical institutions use clinically verified by the medical institution, safe and effective fixed prescription, and is limited to the internal clinical use of medical institutions. Since 1985, China has implemented a licensing system for the preparation of preparations for medical institutions.
Provincial drug supervision approval
Medical institution preparations fixed prescription, preparation process is mature, the internal use of medical institutions, with risk controllability. Historically, after the implementation of licensing of medical institution preparations, it has been approved by the provincial drug supervision and management department, which not only meets the clinical needs, but also ensures the safety of use, and there has not been any influential drug incidents caused by medical institution preparations. In addition, many medical institutions for the preparation of Chinese medicine preparation, prescription sources and formation of regional, provincial drug supervision and management departments to approve more familiar with the situation.
Legal status is clear
Medical institution preparation license is to obtain the preparation of medical institutions to prepare the signs and licenses. The contents of the medical institution preparation license include: the name of the medical institution, social credit code, registered address, the type of medical institution, the legal representative, the person in charge of the preparation room, the person in charge of quality, the dispensing address and the scope of the dispensing, the license number, the daily supervisory body, the telephone number for complaints and reports, the licensing authority, the issuer, the time of issuance of the license, the validity of the license and other content. The license is generally valid for five years, by the State Drug Administration unified supervision. ? Preparation License for Medical Institutions" is the qualification certificate of medical institutions to prepare preparations, is a medical institution to prepare preparations for the site, personnel, equipment, testing, sanitation, environment, management system and other conditions, by the supervisory authorities to check and acceptance of compliance with the statutory requirements for recognition. Medical institutions without such a certificate shall not be prepared preparations.
Dynamic management
Medical institutions preparation license should be marked with the expiration date, the expiration of the re-examination of the issuance of certificates, which is the same as the "Drug Administration Law" provides for other licenses. With the national drug supervision and management policies, changes in the drug market, new technologies, new techniques in the preparation of medical institutions in the use of preparations, as well as the development of health care system reform, the conditions of the preparation of medical institutions will also change, so the need for dynamic management, the expiration of the validity of the expiration date, based on the new provisions and requirements of the re-examination of the license. At present, the "medical institution preparation license" application, approval procedures and management, mainly based on the former State Food and Drug Administration Bureau Order No. 18 June 1, 2005 came into force, issued by the "medical institution preparation supervision and management methods" (for trial implementation).