Measures for the Administration of Drug GSP Certification.
Article 1 In order to strengthen the quality management of drug business and ensure the safety and effectiveness of people's drug use, these measures are formulated in accordance with the Drug Administration Law of the People's Republic of China and other relevant laws and regulations.
Article 2 These measures apply to pharmaceutical wholesale enterprises and retail enterprises, and other drug production and trading enterprises can also refer to these measures.
Article 3 Pharmaceutical trading enterprises shall carry out drug GSP certification and supervision and inspection in accordance with the provisions of these Measures, and complete the relevant certification work as required.
Article 4 The State Food and Drug Administration is responsible for formulating drug GSP certification standards and certification procedures, and is responsible for supervising and inspecting drug GSP certification.
Article 5 The GSP certification of drugs shall adhere to the principles of science, justice, fairness and openness, and strictly abide by the provisions of relevant national laws and regulations.
Article 6 The GSP certification of drugs shall follow the principle of voluntary application by enterprises and be carried out in strict accordance with the certification procedures.
Article 7 Enterprises applying for drug GSP certification shall establish and improve the quality management system for drug operation in accordance with the requirements of the "Good Practice for Drug Operation" and ensure its effective operation.
Article 8 Enterprises applying for drug GSP certification shall meet the following conditions:
1) Have independent legal personality;
2) The "Drug Business License" and the "Business License of Enterprise Legal Person" have been obtained;
3) A drug management quality management system has been established in accordance with the requirements of the "Good Manufacturing Practice for Pharmaceutical Operations" and its effective operation has been ensured
4) The application for drug GSP certification has been carried out in accordance with the regulations.
Article 9 Enterprises applying for drug GSP certification shall submit the following materials to the food and drug supervision and administration departments of the provinces, autonomous regions and municipalities directly under the Central Government:
1) Application for GSP certification of drugs;
2) Copies of "Drug Business License" and "Business License of Enterprise Legal Person";
3) Application report for certification of good management standards for drug operation of enterprises;
4) Organizational structure and functions of enterprise quality management;
5) Enterprise drug management quality management system documents;
6) The list of the person in charge of the enterprise, the person in charge of quality management, the pharmacy technician and the technician of traditional Chinese medicine, and the copy of the academic qualifications, professional titles, professional qualifications or practice registration certificates;
7) Floor plan of the business premises and warehouse of the enterprise;
8) The procedure documents and work manuals formulated by the enterprise in accordance with the requirements of the "Good Practice for Drug Operation".
Article 10 The food and drug supervision and administration departments of provinces, autonomous regions and municipalities directly under the Central Government shall, within 15 working days from the date of receipt of the application materials, review the application materials and organize on-site inspections. For those who meet the requirements, the "Drug GSP Certification Notice" shall be issued to the applicant enterprise and publicized in accordance with the relevant regulations;If the requirements are not met, the applicant enterprise shall be notified in writing and the reasons shall be explained.