China Food and Drug Regulatory Information Network
 
contant us
Home Market Overview Conferences BBS
International Exchange & Forums
Introduction to E-newsletter
Profile of Industry
Laws & Regulations - Drugs - Provisions for Classified Administration of Prescription and Nonprescription Drugs (for trial implementation)
Provisions for Classified Administration of Prescription and Nonprescription Drugs (for trial implementation)
(SDA Decree No. 10)
2011/8/9 14:53:59 Source:  Hits:

  The Provisions for Classified Administration of Prescription and Nonprescription Drugs (for trial implementation), adopted at the executive meeting of the State Drug Administration (SDA) on June 11, 1999, is promulgated now and shall go into effect as of January 1, 2000.

June 18, 1999

  Article 1 The Provisions for Classified Administration of Prescription and Nonprescription Drugs was formulated with a view to safeguarding the safety, effectiveness and convenience for the people in use of drugs in accordance with the Decision of the Central Committee of the Communist Party of China and the State Council Concerning Public Health Reform and Development.

  Article 2 Drugs shall be regulated as prescription drugs and nonprescription drugs respectively according to their varieties, specifications, indications, dosages and routes of administration.

  Prescription drugs may only be prepared, purchased and used with a prescription from a licensed doctor or a licensed assistant doctor; nonprescription drugs may be determined, purchased and used at one¨s own discretion without a prescription from a licensed doctor or a licensed assistant doctor.

  Article 3 The State Drug Administration is responsible for formulating the Provisions for Classified Administration of Prescription and Nonprescription Drugs. Drug regulatory departments at all levels are responsible for organizing, implementing and supervising classified administration of prescription and nonprescription drugs within their respective jurisdictions.

  Article 4 The State Drug Administration is responsible for selecting, approving, releasing and adjusting the list of nonprescription drugs.

  Article 5 A manufacturer of prescription or nonprescription drugs must hold a Drug Manufacturing Enterprise Certificate, and each of its products must come with a drug approval number.

  Article 6 The label and insert sheet of a nonprescription drug shall meet the requirements and be scientific and understandable in wording to facilitate consumers in deciding, selecting and using the drug at their own discretion. The label and insert sheet of a nonprescription drug must be approved by the State Drug Administration.

  Article 7 The packaging of a nonprescription drug must be printed with the specific identification mark for a nonprescription drug specified by the State, in compliance with quality requirements and conducive to storage, transport and use. The package of each basic sales unit must be attached with a label and insert sheet.

  Article 8 Nonprescription drugs are divided into Class A and Class B according to drug safety features.

  A wholesale enterprise dealing in prescription or nonprescription drugs and a retail enterprise dealing in prescription drugs or Class A nonprescription drugs must hold a Drug Distributing Enterprise Certificate.

  Other commercial enterprises approved by a provincial-level drug regulatory department or one of their authorized drug regulatory departments may deal in retail of Class B nonprescription drugs.

  Article 9 A commercial enterprise engaged in retailing Class B nonprescription drugs must have fulltime staff members with a senior high school education level (or above) who, after professional training, has passed the examination by a provincial-level drug regulatory department or its authorized drug regulatory department and obtained a job permit.

  Article 10 A medical institution may decide or recommend the use of a nonprescription drug according to medical needs.

  Article 11 A consumer has the right to select and purchase (a) nonprescription drug(s) at his/her own discretion and use the drug(s) as indicated in the label and insert sheet.

  Article 12 A prescription drug may only be advertised in professional medical journals and newspapers; a nonprescription drug may be advertised in mass media upon approval.

  Article 13 In the classified administration of prescription drugs and nonprescription drugs, specific rules for the examination and approval, distribution and advertising shall be formulated separately.

  Article 14 The Provisions shall be interpreted by the State Drug Administration.

  Article 15 The Provisions shall go into effect as of January 1, 2000.

Laws & Regulations more
Medical Devices more
CHINA CENTER FOR PHARMACEUTICAL INTERNATIONAL EXCHANGE