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The owner must be carefully studied, especially the second chapter (the start of the application and approval of drug production enterprises) and the third chapter (the management of drug production licenses)
The owner must be carefully studied, especially the second chapter (the start of the application and approval of drug production enterprises) and the third chapter (the management of drug production licenses)
The owner should be careful to learn the first chapter (the application of drug production enterprises). Production License Management)
Attached is a summary of the "Drug Production Supervision and Administration Measures":
Chapter II Application and Approval of Drug Manufacturing Enterprises
Article 4 The establishment of drug manufacturing enterprises, in addition to the drug industry development plan and industrial policy formulated by the state, should also meet the following conditions:
(a) have the qualification of the recognized by law. Pharmacy technicians, engineers and corresponding skilled workers, the enterprise's legal representative or the person in charge of the enterprise, the person in charge of quality is not "Drug Administration Law," Article 76 of the circumstances;
(b) with its pharmaceutical production of plant, facilities and sanitation environment;
(c) with the production of drugs for quality management and quality inspection of the institutions, personnel As well as the necessary instruments and equipment;
(D) have to ensure the quality of drugs regulations.
The relevant state laws and regulations on the production of narcotic drugs, psychotropic drugs, toxic drugs for medical use, radioactive drugs, drugs and other chemicals, in accordance with its provisions.
Article 5 The applicant to open a pharmaceutical production enterprise, shall apply to the drug supervision and management department of the province, autonomous region and municipality directly under the Central Government (food) where the proposed enterprise is located, and submit the following materials:
(a) the basic situation of the applicant and its relevant documents;
(b) the basic situation of the proposed enterprise, including the name of the proposed enterprise, the production of varieties, dosage form (b) the basic information of the proposed enterprise, including the name of the proposed enterprise, production varieties, dosage forms, equipment, process and production capacity; the site of the proposed enterprise, the surrounding environment, infrastructure and other conditions, as well as the scale of investment and other information;
(c) the notification of pre-approval of the name of the proposed enterprise issued by the administrative department for industry and commerce, the production address and the registered address, the type of enterprise, the legal representative or person in charge of the enterprise;
(d) the organization chart of the proposed enterprise ( Indicate the duties and interrelationships of each department and the person in charge of the department);
(E) the legal representative of the proposed enterprise, the person in charge of the enterprise, the person in charge of the department of the curriculum vitae, academic qualifications and professional title certificate; according to the law through the qualification of pharmacy and related professional and technical personnel, engineers and technicians, skilled workers register, and indicate the department and position; senior, intermediate, junior technicians, the proportion of the situation table;
(F) the proposed enterprise's surrounding environment, general layout, warehousing layout, quality inspection site layout;
(G) the proposed enterprise's production process layout plan (including locker rooms, washrooms, human and logistics channels, air locks, and so on, and indicate the direction of people, flow and air cleanliness level), air purification system, air supply, air return, air exhaust Layout plan, process equipment layout plan;
(H) the scope of the proposed production, dosage forms, varieties, quality standards and the basis;
(IX) the proposed production of dosage forms and varieties of the process flow diagram, and indicate the main quality control points and projects;
(J) air purification system, water system, the main equipment to verify the general situation; production, inspection instruments, meters and scales Calibration;
(k) the main production equipment and inspection instruments catalog;
(l) the proposed enterprise production management, quality management documents catalog.
The applicant shall be responsible for the authenticity of all contents of its application materials.
Article 6 The pharmaceutical production enterprises will be part of the production plant separation, the formation of independent drug manufacturers, in accordance with the provisions of Article 4 and Article 5 of these Measures for the "Drug Production License".
Article VII provinces, autonomous regions, municipalities directly under the Central Government (food) drug supervision and management department receives the application, shall be dealt with in accordance with the following:
(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, it shall allow the applicant to apply for (B) the application materials there are errors that can be corrected on the spot, the applicant shall be allowed to correct on the spot;
(C) the application materials are incomplete or do not meet the requirements of the form of review, 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 all the contents of the need to make corrections, and notify the applicant of any delay in notifying the applicant of the application materials received from the date of the application will be deemed to be admissible;
(D) Application materials are complete, meet the formal review 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 application for the start-up of pharmaceutical production enterprises, should be issued with the special seal of acceptance of the department and the date of the "Notice of Acceptance" or "Notice of Inadmissibility".
Article VIII provinces, autonomous regions, municipalities directly under the Central Government (food) drug supervision and management departments shall, within 30 working days from the date of receipt of the application, make a decision.
The review meets the requirements, be approved, and written approval of the decision to issue within 10 working days from the date of issuance of the "Drug Manufacturing License"; does not meet the requirements, make a written decision not to approve, and explain the reasons, while informing the applicant enjoys the right to apply for administrative reconsideration or bring an administrative lawsuit according to law.
Article IX of the new start-up pharmaceutical production enterprises, pharmaceutical production enterprises, new drug production plant or new production of dosage forms, should be obtained from the production of drugs or approved by the official production of documents within 30 days from the date of approval, in accordance with the provisions of the State Food and Drug Administration to the corresponding (food) drug supervision and management departments to apply for "Drug Production Quality Management Standard" certification.
Article 10 Provinces, autonomous regions, municipalities directly under the Central (food) Drug Administration shall publicize in the administrative organs of the website and office space to apply for the "Drug Manufacturing License" required conditions, procedures, deadlines, the need to submit all the materials of the table of contents and the application form model text.
Provinces, autonomous regions, municipalities directly under the Central Government (food) drug supervision and management departments to issue the "drug production license" of the relevant information should be made public, the public has the right to access.
Article 11 Provinces, autonomous regions, municipalities directly under the Central Government (food) drug supervision and management departments of the drug production enterprises to start the application review, shall publicize the approval process and approval results. Applicants and interested parties can submit written comments on matters directly related to their vital interests for presentation and defense.
Article 12 The application for the establishment of pharmaceutical production enterprises directly involves the applicant and others with significant interests, provinces, autonomous regions, municipalities directly under the Central Government (food) drug supervision and management departments shall inform the applicant, the interested party can be in accordance with the laws, regulations and the State Food and Drug Administration and the right to apply for a hearing of other provisions; in the application for the establishment of pharmaceutical production enterprises to review. Provinces, autonomous regions, municipalities directly under the Central Government (food) drug supervision and management department that involves public **** interests of major licensing matters, should be announced to the community, and held hearings.
I hope to be useful to the owner, good luck!