Can private individuals apply for traditional medicine filing?

Private individuals cannot apply for drug filing, but medical institutions can. Here is a brief introduction.

I. Project Name

Matters related to filing in the preparation room of medical institutions

1, the person in charge of the drug testing room has changed.

2. Change of the person in charge of the quality management organization

3. The key configuration facilities have changed.

Second, the basis

Measures for the Supervision and Administration of Preparations in Medical Institutions (for Trial Implementation)

Standard for quality management of pharmaceutical preparations in medical institutions (for Trial Implementation)

Third, the application materials

1, the person in charge of the quality organization and the person in charge of the drug testing room change for the record:

(1) Catalogue of application materials and statement of authenticity self-assurance;

(2) Power of attorney of the legal representative;

(3) medical institutions for the record report;

(4) Notice of appointment and dismissal of medical institutions;

(five) change the resume of personnel;

(6) A copy of the certificate of relevant academic qualifications and technical titles of the change personnel;

2, medical institutions, preparation room and other key production facilities conditions and state changes for the record:

(1) Catalogue of application materials and statement of authenticity self-assurance;

(2) Power of attorney of the legal representative;

(3) medical institutions for the record report;

(4) Formulas, varieties and technological processes related to changes in conditions such as key production facilities (indicate main quality control points and projects);

(5) Description of the name, model and production capacity of the preparation room, facilities and equipment before and after the change;

(6) Layout of production technology, equipment, warehouse layout, area and air purification system before and after the change;

(7) If the air purification system and clean area change and need to be re-tested, the performance test report of clean room (area) shall be submitted;

(8) Verification after change;

(9) Other materials that need to be submitted.

Four. Format and requirements of application materials

(a) the application materials are complete and clear, imitating Song No.4, printed or copied on one side of A4 paper, and the contents and page numbers are arranged in turn according to the data requirements, and bound into a book.

(two) the application materials should be stamped with the official seal; All copies shall be marked with the words "This copy is consistent with the original" or written explanation, with the date and official seal; If the copy of a single material exceeds 2 pages (including 2 pages), it shall be stamped with the seal of riding seam.

(3) The power of attorney shall specify the entrusted contents and attach a copy of the trustee's ID card. The power of attorney shall be signed by the legal representative and stamped with the official seal of the medical institution.