Medical institution preparation license is valid for five years. Medical institution preparations, refers to the medical institutions in accordance with the clinical needs of the unit approved by the preparation, self-use of fixed prescription preparations. The preparations prepared by medical institutions should be of varieties not available on the market.
Legal basis:
Article 3 of the Measures for the Administration of Registration of Preparations for Medical Institutions
Medical institution preparation refers to the fixed prescription preparations prepared by the medical institution for self-administration with approval according to the clinical needs of the institution. The preparations prepared by medical institutions should be varieties not available on the market.
Article 5 of the Administrative Measures for the Registration of Preparations for Medical Institutions
The applicant for a preparation for medical institutions shall be a medical institution that holds a "license to practice in a medical institution" and has obtained a "license to prepare preparations for medical institutions". Did not obtain a "medical institution preparation license" or "medical institution preparation license" without the corresponding preparation form of "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 should be the medical institution that obtains the "Preparation License for Medical Institutions" or the pharmaceutical manufacturer that obtains the certification of "Good Manufacturing Practice". Commissioned to formulate the preparation of dosage forms should be consistent with the entrusted party to hold the "preparation license for medical institutions" or "pharmaceutical production quality management standard" certificate of authentication of the scope of the same.