The medical institution preparation license is valid for 5 years. Medical institution preparations refer to fixed prescription preparations prepared by medical institutions for their own use with approval based on the clinical needs of the unit. Preparations prepared by medical institutions should be of a variety not available on the market.
How to apply for a medical institution practice license
The unit or individual applying to set up a medical institution shall submit an application report for the "Medical Institution Practice License" to the County Health Bureau and fill in the "Medical Practice Registration" "Registration Letter" should be submitted:
1. List of legal representatives or principals of medical institutions and heads of departments and copies of relevant qualification certificates, practice certificates, and ID cards;
2. Proof of property ownership or use of the medical institution;
3. Architectural design plan of the medical institution;
4. Capital verification certificate, asset evaluation report;
5. List of general equipment and list of drug types.
The process for applying for a medical institution practice license:
1. The unit manager brings the above information to the health administration department to apply;
2. After passing the review, If the applicant fails to pass the review, the applicant will be notified in writing of the review results and the reasons for disapproval
Legal basis
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Full Text of "Measures for the Registration and Management of Preparations in Medical Institutions"
Article 3 Preparations for medical institutions refer to fixed prescription preparations prepared by medical institutions for their own use upon approval based on the clinical needs of the unit.
Preparations prepared by medical institutions should be varieties not available on the market.
Article 4: The State Food and Drug Administration is responsible for the supervision and management of preparations in medical institutions nationwide.
The (food) drug regulatory authorities of provinces, autonomous regions, and municipalities directly under the Central Government are responsible for the approval, supervision and management of preparations by medical institutions within their respective jurisdictions.
Article 5: Applicants for medical institution preparations shall be medical institutions that hold a "Medical Institution Practice License" and obtain a "Medical Institution Preparation License".
Medical institutions in the "hospital" category that have not obtained a "Medical Institution Preparation License" or a "Medical Institution Preparation License" that does not have a corresponding preparation dosage form can apply for medical institution traditional Chinese medicine preparations, but they must also submit a commission to prepare the preparations. application. The unit that accepts entrusted preparation shall be a medical institution that has obtained the "Medical Institution Preparation License" or a pharmaceutical manufacturer that has obtained the "Good Manufacturing Practice for Pharmaceutical Products" certification. The dosage forms of preparations entrusted to be prepared shall be consistent with the scope stated in the "Medical Institution Preparation License" or "Good Manufacturing Practice" certification held by the entrusted party.
Article 6: Medical institution preparations can only be used within the medical institution with the prescription of a licensed physician or a licensed assistant physician, and shall be consistent with the scope of diagnosis and treatment stated in the "Medical Institution Practice License."
Article 31: The validity period of the preparation approval number of a medical institution is 3 years. If the validity period expires and it is necessary to continue preparation, the applicant shall submit a re-registration application and submit relevant materials in accordance with the original application preparation procedures 3 months before the expiration of the validity period.
2. Description
1. Documentation item 3 supporting documents include:
(1) Copy of "Medical Institution Practice License" and "Medical Institution Preparation License";
(2) Medical Institution The patent status of the preparation or the used prescription, process, etc. and a description of its ownership status, as well as a guarantee that it will not infringe the patents of others;
(3) Provide documents proving the legal source of chemical raw materials, including : Copies of approval documents, sales invoices, inspection reports, drug standards and other materials for raw materials;
(4) Copies of registration certificates of packaging materials and containers that come into direct contact with preparations;
(5) A copy of the "Approval Document for Clinical Research of Preparations from Medical Institutions".
(6) If a medical institution in the "hospital" category that has not obtained a "Medical Institution Preparation License" or a "Medical Institution Preparation License" and does not have a corresponding preparation dosage form applies for traditional Chinese medicine preparations from a medical institution, it should also provide the following information : The entrusted preparation contract signed by both parties entrusting the preparation of traditional Chinese medicine preparations, and a copy of the preparation preparation unit's "Medical Institution Preparation License" or "Pharmaceutical Good Manufacturing Practice" certification certificate.
2． The functions and indications of TCM preparations must be expressed using TCM terminology and TCM disease names.
3. Traditional Chinese medicine preparations should be compared with the varieties included in the national drug standards, including:
(1) Prescription composition;
(2) Principle and law characteristics;
(3) Functional treatment.
4. Information item 10: The self-inspection report of the sample refers to the inspection report issued by the medical institution after inspecting the preparation. When submitting pre-clinical research data, self-test reports for three consecutive batches of samples should be provided. If a medical institution in the "hospital" category that has not obtained a "Medical Institution Preparation License" or a "Medical Institution Preparation License" and does not have a corresponding preparation dosage form applies for traditional Chinese medicine preparations from a medical institution, it shall provide three consecutive batches of preparation samples issued by the entrusted preparation unit. Self-test report.
5． The prescription is formulated according to the theory of traditional Chinese medicine and is prepared using traditional techniques (that is, the preparation process does not change the material basis for treating the disease in the original prescription), and the prescription has a history of use in this medical institution for more than 5 years (including 5 years). Traditional Chinese medicine preparations are exempt from reporting information items 13-17. However, if one of the following circumstances applies, information items 14 and 15 need to be submitted:
(1) The prescription contains medicinal materials that are toxic in legal standards and proven toxic by modern toxicology;
(2) The composition of the prescription contains incompatible substances such as Shibaban and Shibafan;
(3) The dosage of medicinal flavor in the prescription exceeds the drug standards.
6． If the chemical preparation you apply for preparation has already obtained the preparation approval number for the same variety, you can be exempted from reporting information items 13-17.
7. Preclinical application materials items range from 1 to 16.
8. When submitting clinical research summary data, three consecutive batches of self-inspection reports based on reviewed quality standards should be submitted at the same time.
9. Application materials must be printed on A4 paper in triplicate.