|
Welcome Guest
|
|
You are using Guest Account
|
|
||||||||||||||||||||||||||||||||||
|
We hereby issue the information as to the revision, repeal and reservation of the ministerial rules of the State Food and Drug Administration involving administrative examinations and approvals under the requirements of the Circular of the State Council Regarding Implementing the P.R.C Administrative Permit Law (No.23 [2003] of the State Council) and the Circular of the General Office of the State Council Regarding the Work Schedule Relating to Implementing the Administrative Permit Law with a view to insuring the smooth implementation of the Administrative Permit Law in the regulatory system of food and drug. If there is any inconsistency between the provisions relevant to the administrative permit in the administrative rules now in effect and those in the Administrative Permit Law, the provisions of the Administrative Permit Law shall prevail. I. REVISED ADMINISTRATIVE RULES Nine of the administrative rules involving administrative permit that shall be revised under the Administrative Permit Law: (1) The Measures Regarding the Administration of the Registration of Medical Appliances (as revised) shall be effective as of the date of its promulgation, and the Measures Regarding the Administration of Medical Appliances issued by Order No. 16 of the State Drug Administration shall be repealed simultaneously; (2) The Measures Regarding the Supervision and Regulation of the Production of Medical Appliances shall be effective as of the date of its promulgation, and the Measures Regarding the Supervision and Regulation of Medical Appliance Production Enterprises issued by Order No. 18 of the State Drug Administration shall be repealed simultaneously; (3) The Measures Regarding the Administration of the Permit for Enterprises Dealing in Medical Appliances shall be effective as of the date of its promulgation, and the Measure Regarding the Supervision and Regulation of the Permit for Enterprises Engaged in Medical Appliances issued by Order No. 19 of the State Drug Administration shall be repealed simultaneously; (4) The Measures Regarding the Administration of the Packaging Materials and Containers Directly Touching Drugs shall be effective as of the date of its promulgation, and the Measures Regarding the Administration of Materials and Containers for Packaging Drug (Tentative) issued by Order No. 21 of the State Drug Administration shall be repealed simultaneously; (5) The Measures Regarding the Administration of Internet Drug Information Service shall be effective as of the date of its promulgation, and The Interim Measures Regarding the Administration of Internet Drug Information Service issued by Order No. 26 of the State Drug Administration shall be repealed simultaneously; (6) The Provisions Regarding the Administration of the Specifications, Labels and Packaging Marks of Medical Appliances shall be effective as of the date of its promulgation, and the Provisions Regarding the Administration of the Specifications of Medical Appliances issued by Order No. 30 of the State Drug Administration shall be repealed simultaneously; (7) The Measures Regarding the Administration of Drug Registration shall be effective as of the date of its promulgation, and The Measures Regarding the Administration of Drug Registration (Tentative) issued by Order No. 35 of the State Drug Administration shall be repealed simultaneously; (8) The Measures Regarding the Administration of the Batch-based Endorsement for Biological Products shall be effective as of the date of its promulgation, and the Measures Regarding the Administration of the Batch-based Endorsement for Biological Products (Tentative) issued by Order No. 36 of the State Drug Administration shall be repealed simultaneously; and (9) The Measures Regarding the Supervision and Regulation of the Production of Drugs shall be effective as of the date of its promulgation, and The Measures Regarding the Supervision and Regulation of the Production of Drugs (Tentative) issued by Order No. 37 of the State Drug Administration shall be repealed simultaneously; II. UN-REVISED ADMINISTRATIVE RULES Three administrative rules involving administrative permit that need not be revised under the Administrative Permit Law: (1) The Provisions Regarding the Examination and Approval of New Products Classified as Medical Appliances (Tentative) issued by Order No. 17 of the State Drug Administration; (2) The Measures Regarding the Administration of the Import of Drugs issued by Order No. 4 of the State Drug Administration and the General Administration of Customs of the P.R.C; and (3) The Measures Regarding the Administration of Drug Business License issued by Order No. 6 of the State Food and Drug Administration; III. UN-REPEALED AND UN-REVISED ADMINISTRATIVE RULES UNTIL THE PROMULGATION Two administrative rules involving administrative permit that shall not be repealed and revised until the promulgation of relevant regulations by the State Council: (1) The Measures Regarding the Administration of Ephedrine (Tentative) issued by Order No. 12 of the State Drug Administration; and (2) The Measures Regarding the Administration of Caffeine issued by Order No. 12 of the State Drug Administration. IV. REPEALED ADMINISTRATIVE RULE One administrative rule involving administrative permit that shall be repealed under the requirements of the Administrative Permit Law: The Measures Regarding the Administration of Medications for Drug Addiction Treatment issued by Order No. 11 of the State Drug Administration V. UN-REVISED ADMINISTRATIVE RULE INVOLVING NON-ADMINISTRATIVE PERMIT One administrative rule involving non-administrative permit and examination and approval that need not be revised: The Detailed Implementing Rules for the Administrative Protection of Drugs issued by Order No. 25 of the State Drug Administration. |
||||||||||||||||||||||||||||||||||
|
||||||||||||||||||||||||||||||||||
|
Copyright 2002 NovexCn.com
|