Provinces, autonomous regions, municipalities directly under the Central Government (food) drug supervision and management departments are responsible for the supervision and management of the preparation of medical institutions under their jurisdiction. Article V medical institutions shall comply with the preparation of preparations, "the preparation of medical institutions preparation quality management standard. Chapter II Permission to Establish Preparation Room in Medical Institutions Article 6 Medical institutions to prepare preparations, must have the personnel, facilities, testing instruments, sanitary conditions and management system to ensure the quality of preparations. Article VII of the medical institutions to set up a preparation room, shall be the location of the province, autonomous region, municipality directly under the Central Government (food) drug supervision and management department to submit the following materials:
(a) "medical institutions preparation license application form" (see Annex 1);
(b) the implementation of the "medical institutions preparation quality management standard" self-examination report;
(c) the basic situation of the medical institution and a copy of the License to Practice in Medical Institutions;
(iv) the approval opinion of the health administrative department of the province, autonomous region or municipality directly under the central government of the location;
(v) the basic situation of the proposed preparation room, including the scale of investment in the preparation room, the area, the surrounding environment, infrastructure, and other conditions of the description, and to provide the general layout plan of the medical institution, the general layout plan of the preparation room ( Marked air cleanliness level);
Resume of the person in charge of the preparation room, the person in charge of the pharmacy, preparation quality management organization (including name, age, gender, education, major, position, title, years of original work in pharmacy, etc.) and professional and technical personnel accounted for the proportion of the staff of the preparation room;
Preparation room in charge of the person in charge of the pharmacy, the person in charge of the pharmacy, the preparation of the organization of quality management The person in charge shall be the professional staff on duty in the unit, and the person in charge of the preparation room and the person in charge of the drug testing room shall not be appointed concurrently with each other;
(f) the proposed preparation of dosage forms, preparation capacity, varieties, specifications;
(g) the process flow chart of the preparation of dosage forms, the quality standard (or a draft);
(h) the catalog of the main preparation equipment, testing instruments;
(ix) Preparation preparation management, quality management documents catalog. Article 8 The applicant shall be responsible for the authenticity of its application materials. Article IX provinces, autonomous regions, municipalities directly under the Central Government (food) drug supervision and management department receives the application, shall be dealt with according to the following circumstances:
(a) the application does not belong to the department's terms of reference, it shall make a decision of inadmissibility immediately, and inform the applicant to the relevant administrative organs;
(b) the application materials can be corrected on the spot errors, the applicant shall be allowed to correct on the spot;
(c) the application materials can be corrected on the spot errors. The applicant shall be allowed to correct on the spot;
(c) the application materials are incomplete or do not meet the formal review requirements, shall be issued on the spot or within five working days to the applicant, "Notice of Corrective Material", a one-time notification to the applicant of the need to make corrections to all the contents of the application materials are not informed of the late, from the date of receipt of the application materials will be admitted;
(d) the application materials are complete, meet the formal review requirements, or the applicant in accordance with the requirements of (d) the application materials are complete, meet the formal examination requirements, or the applicant in accordance with the requirements to submit all corrective materials, be accepted.
Provinces, autonomous regions, municipalities directly under the Central Government (food) drug supervision and management departments to accept or not accept the "medical institution preparation license" application, should be issued with the department's special seal and date of acceptance of the "Notice of Acceptance" or "Notice of Inadmissibility". Article X provinces, autonomous regions, municipalities directly under the Central (Food) Drug Administration shall receive the application within 30 working days from the date of receipt, in accordance with the State Food and Drug Administration formulated the "medical institution preparation license acceptance criteria" organization acceptance. Acceptance, be approved, and from the date of approval of the decision within 10 working days from the date of issuance of the applicant's "medical institution preparation license"; unqualified acceptance, make a decision not to approve the applicant in writing and explain the reasons, and inform the applicant of the right to apply for administrative reconsideration or administrative litigation according to law.
Provinces, autonomous regions, municipalities directly under the Central (Food) Drug Administration after acceptance, should be issued from the "medical institution preparation license" within 20 working days from the date of the relevant information to the State Food and Drug Administration for the record. Article XI provinces, autonomous regions, municipalities directly under the Central Government (food) drug supervision and management departments should be in the office premises to publicize the application for "medical institutions preparation license" required matters, basis, conditions, deadlines, all the materials to be submitted to the directory and the application of the model text and so on.
Provinces, autonomous regions, municipalities directly under the Central Government (food) drug supervision and management departments to issue "medical institutions preparation license" of the relevant decisions shall be made public, the public has the right to access. Article 12 Provinces, autonomous regions, municipalities directly under the Central Government (food) drug supervision and management departments in the medical institutions to start the application for review of the preparation room, shall publicize the approval process and the results of the approval. Applicants and interested parties can submit written comments on matters directly related to their vital interests for presentation and defense.