1. To be responsible for revising the relevant provisions and measures for the production license of pharmaceutical products, and organize their implementation;
2. Organize the formulation of product catalogues and batch implementation plans for the implementation of production licenses, and send them to the National Industrial Products Production License Office (hereinafter referred to as the National License Office) for approval and publication;
3. Be responsible for formulating detailed rules for the implementation of product production licenses, assessment methods and charging standards; And report to the National License Office for approval;
iv. examine and approve the conditions of product quality inspection and testing units, and report them to the national licensing office for examination and approval;
5. Organize assessment and testing of the product quality assurance system and product quality of the applicant enterprise.
VI. Handling the numbering and certification of the production license of pharmaceutical products approved by the Bureau;
VII. Supervise and manage enterprises that have obtained production licenses for pharmaceutical products. Article 5 The marking and numbering of the production license of pharmaceutical products shall adopt the national unified nine-digit Arabic numeral coding method, Its distribution is:
XK24 1 1 medical instrument products
XK24 21 1 Chinese patent medicine, integrated Chinese and western medicine products
XK24 51 1 chemicals
XK24 91 1 pharmaceutical machinery products
XK24 95 1 medical packaging materials, Container
No. of production license (3)
No. of product (2)
No. of State Administration of Medicine (1)
Note: (1) is the unified number of the country, and the State Administration of Medicine is 24.
(2) The product numbers are arranged according to the order in which production licenses are issued for professional products.
(3) The production license numbers are arranged continuously in the order of acceptance.
X stands for XU, and k stands for ke
Marks and numbers must be used on the packaging or instructions of the product. Article 6 To obtain a production license, an enterprise must meet the following conditions:
1. The enterprise must hold a business license issued by the administrative department for industry and commerce; The product must have a registered trademark.
second, chemicals must hold the approval number of the administrative department of health.
3. The quality of chemicals must meet the current national standards or the industry standards higher than the Pharmacopoeia standards. The quality of medical devices, pharmaceutical machinery, pharmaceutical packaging materials and containers must meet the current national standards or professional standards (ministerial standards), and the correct and complete drawings or technical documents approved according to the prescribed procedures. Article 7 Procedures for application and examination and approval of pharmaceutical product production license:
1. Enterprises applying for pharmaceutical product production license must apply within the prescribed application period, and enterprises that fail to apply within the time limit shall be deemed as automatic waiver. The applicant enterprise shall fill in the application form in duplicate according to the uniform format stipulated by the license office of the bureau, and submit it to the license office of the bureau after being examined and sealed by the license office of the province, autonomous region or municipality directly under the central government and the competent department of medicine.
2. the license office of the bureau will (or entrust) the pharmaceutical administrations of provinces, autonomous regions, municipalities directly under the central government and cities under separate state planning to form a review team, and under the leadership of the production license offices of provinces, autonomous regions, municipalities directly under the central government and cities under separate state planning, inspect and assess the applicant enterprises according to the detailed rules and assessment methods for product implementation, and arrange spot checks to test the product quality.
3. Any enterprise that has passed the inspection and assessment by the review team shall be issued a production license after being reported to the National License Office for the record by the Bureau License Office, and the list shall be published uniformly by the National License Office.
4. Any enterprise that fails to pass the inspection and assessment by the inspection team must be rectified (including the deadline and suspension of production for rectification, which shall not exceed half a year) and then reapply. If it still fails to pass the second inspection and assessment, the application qualification will be cancelled.
5. The validity period of the production license for pharmaceutical products is tentatively set at five years. After the expiration of the production license, if the enterprise continues to produce the product, it shall re-apply according to the requirements of these Measures and the detailed rules for the implementation of the product two months before the expiration.
6. Before organizing mass production, newly-built enterprises or newly-put products should apply.