The drug packaging labeling instructions for the record, for example, the procedures are as follows:
(a) the applicant to the provincial bureau of government affairs acceptance department to submit the declaration materials. Provincial government acceptance department within 5 working days for review, meet the requirements of the regulations, issued a "notice of acceptance", the material will be transferred to the evaluation and certification center;
(b) evaluation and certification center in 15 working days to complete the audit work after the issuance of the audit opinion, the material will be transferred to the Office of Drugs and Cosmetics Registration Management;
(c) the Office of Drugs and Cosmetics Registration Management in 10 (C) the Drug and Cosmetic Registration Administration in 10 working days to complete the review and production of supplemental application filing electronic version or "Notice of Approval Opinions", transferred to the provincial government acceptance department;
(D) the Drug and Cosmetic Registration Administration in 5 working days to upload the supplemental application filing electronic version of the database of the General Administration of the State; Provincial Government acceptance department in 5 working days to the applicant to issue "Notice of Approval Opinions";
(E) subject to the approval of the National Bureau of China;
() (E) to be reported to the National Bureau for approval, in accordance with the "Drug Registration Administration" provisions for processing;
(F) individual varieties due to special circumstances, such as equipment and technology, its internal labeling printed generic name, specifications, production batch number and expiration date of the real difficulties, accepted by the Provincial Bureau, reported to the National Bureau for approval, agreed to reduce the content of the labeling.
Expanded information:
Functional Changes
(a) Eliminated Duties.
1. Gradually consolidate the two administrative licenses of drug production and drug production quality management standard certification into one administrative license.
2. Administrative licensing of drug business and pharmaceutical quality management standard certification of two administrative licenses gradually integrated into an administrative license.
3. Production of cosmetics and cosmetic health administrative license administrative license for two administrative licenses into one administrative license.
4. Cancellation of continuing education management of licensed pharmacists, the work of the Chinese Association of Licensed Pharmacists.
5. According to the "State Council Institutional Reform and Functional Transformation Program" need to cancel other duties.
(2) Decentralized duties.
1. Decentralize the certification of quality management standards for drugs and medical devices to provincial food and drug supervision and management departments.
2. The re-registration of drugs and drugs do not change the intrinsic quality of the supplemental application for administrative licensing responsibilities decentralized to the provincial food and drug supervision and management departments.
3. Domestic Class III medical devices do not change the intrinsic quality of the product change the application for administrative licensing responsibilities decentralized to the provincial food and drug supervision and management departments.
4. Will be entrusted with the production of drugs administrative licensing duties decentralized provincial food and drug supervision and management departments.
5. The import of non-special use cosmetics administrative licensing responsibilities delegated to the provincial food and drug supervision and management departments.
Baidu Encyclopedia-State Food and Drug Administration