How to apply for a medical practice license
Applications for the establishment of medical institutions units or individuals to the county health bureau to submit "medical practice license" application report, and fill out the "medical practice registration book" should be submitted:
1, the legal representative or principal officer of the medical institution, as well as a directory of heads of departments and relevant qualification certificates, practicing certificates, ID card copies;
2, medical institutions with property rights or proof of use;
3, medical institutions, architectural design plan;
4, proof of capital verification, asset evaluation report;
5, a list of general equipment and a list of types of drugs.
Medical institutions license process:
1, the unit operator with the above information to the health administrative department to apply;
2, after the examination and approval, issued to the medical institutions license;
3, examination and approval is not qualified, the results of the examination and the reasons for the disapproval of the written form of notification to the applicant
Legal basis
"Medical institutions preparation registration management measures"
Article 3 Medical institution preparation, refers to the medical institutions in accordance with the unit's clinical needs and approved by the preparation, self-use of fixed prescription preparations.
The preparations prepared by the medical institutions shall be the varieties that are not available in the market.
Article IV of the State Food and Drug Administration is responsible for the supervision and management of the preparation of the national medical institutions.
Provinces, autonomous regions, municipalities directly under the Central (food) Drug Administration is responsible for the approval and supervision and management of preparations for medical institutions under its jurisdiction.
Article V. The applicant for the preparation of medical institutions shall be a medical institution that holds a Medical Institution Practice License and has obtained a Medical Institution Preparation License.
Not obtaining a "preparation license for medical institutions" or "preparation license for medical institutions" does not have 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 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". The commissioned preparation of the dosage form 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.
Article VI of the preparation of medical institutions can only be used in the medical institution with a licensed physician or physician assistant prescription, and with the "medical institutions license" contained in the scope of treatment.
Article 31 of the medical institution preparation approval number is valid for three years. The expiration of the validity of the need to continue to formulate, the applicant shall, three months before the expiration of the validity period in accordance with the original application procedures for the formulation of re-registration application, submit the relevant information.
Two, description
1. Information item 3 supporting documents include:
(1) "medical practice license" copy of the "medical institutions," a copy of the "medical preparation license";
(2) medical institutions or the use of the prescription, process, etc., the patent situation and its ownership of the state of the description, as well as other people's patents do not constitute an infringement of the Guarantee;
(3) to provide the legal source of chemical raw materials, including: approval of the raw materials, sales invoices, test reports, drug standards and other information copies;
(4) direct contact with the preparation of packaging materials and containers, a copy of the certificate of registration;
(5) "medical institution preparations for clinical research approvals," a copy of the.
(6) did not obtain the "Preparation License for Medical Institutions" or "Preparation License for Medical Institutions" does not have the corresponding preparation dosage form of "hospital" category of medical institutions applying for medical institutions of traditional Chinese medicine preparations, but also should provide the following information: commissioned to dispense traditional Chinese medicine preparations of the two sides signed a commissioned dispensing contract, the preparations of preparations dispensed by the unit of the "The Preparation License for Medical Institutions" or "Preparation License for Medical Institutions". Preparation License for Medical Institutions" or "Good Manufacturing Practice" certification copy.
2. Functions of Chinese medicinal preparations must be expressed using Chinese medicine terminology, Chinese medicine disease name.
3. Chinese medicinal preparations should be compared with the national drug standards contained in the varieties, including:
(1) prescription composition;
(2) rationale and method of characteristics;
(3) the main function.
4. Information item 10 samples of the self-examination report, refers to the medical institutions to test the preparation and issued a test report. Reporting preclinical study information should be provided when the self-test report of three consecutive batches of samples. Medical institutions that have not obtained the "Preparation License for Medical Institutions" or "Preparation License for Medical Institutions" does not have the corresponding preparation dosage form of "hospital" category of medical institutions applying for medical institutions of traditional Chinese medicine preparations, should provide the commissioned preparation unit issued by the self-inspection report on the samples of three consecutive batches of preparations.
5. According to the theory of traditional Chinese medicine prescription, the use of traditional techniques of preparation (i.e., the preparation process does not make the original prescription of the material basis for the treatment of disease changes), and the prescription in the medical institution has more than 5 years (including 5 years) history of use of Chinese medicinal preparations can be exempted from the information items 13-17. However, if one of the following conditions need to be submitted Information items 14 and 15:
(1) The composition of the prescription contains herbs that are labeled as toxic in the legal standards and are proven to be toxic in modern toxicology;
(2) The composition of the prescription contains the eighteen contraindications and nineteen contraindications in the compounding of drugs;
(3) The dosage of flavors of the prescription exceeds the provisions of the standards of the drugs.
6. Application for the preparation of chemical preparations of the same species has been approved by the preparation number, can be exempted from reporting information items 13-17.
7. Pre-clinical reporting information items 1-16.
8. Clinical research summary information should be submitted at the same time, should be reported in accordance with the quality standards after review of three consecutive batches of self-test report.
9. Declaration of information to be printed, A4 paper, in triplicate.