Measures for the Supervision and Administration of Drug Distribution
Measures for the Supervision and Administration of Drug Distribution
Measures for the Supervision and Administration of Drug Distribution
Order of the State Food and Drug Administartion [2007] No. 26
January 31, 2007
The Measures for the Supervision and Administration of Drug Distribution, adopted at the executive meeting of the State Food and Drug Administration on December 8, 2006, is hereby promulgated and shall go into effect as of May 1, 2007.
Shao Mingli Commissioner of SFDA
Appendix: Measures for the Supervision and Administration of Drug Distribution
Chapter I
Article 1 These Provisions are formulated for the purposes of strengthening drug supervision, regulating drug distribution order and ensuring drug quality in accordance with the Drug Administration Law of the People's Republic of China (hereinafter referred to as Drug Administration Law), the Implementing Regulations of the Drug Administration Law of the People's Republic of China(hereinafter referred to as Implementing Regulations of the Drug Administration Law) and the requirements of the relevant law and regulations.
Article 2 Any institutions or individuals engaged in the purchase, sales and supervision of drugs in the People's Republic of China shall abide by the Provisions.
Article 3 Drug manufacturers, distributors and medical institutions shall be responsible for the quality of the drugs that they produce, distribute or use.
Drug manufacturers and distributors shall carry out reforms and innovations in the direction of pharmaceutical logistics provided that drug quality is assured.
Article 4 The drug regulatory departments encourage individuals and organizations to involve in the social supervision on drug distribution. Individuals or organizations have the right to report or accuse of any violation of the Provisions to the drug regulatory departments.
Chapter II Supervision on Drug Purchase and Sales by Manufacturers and Distributors
Article 5 Drug manufacturers or distributors shall be responsible for their drug purchases and sales, and liable for the purchases and sales activities of their sales staff or offices in the name of their enterprise.
Article 6 Drug manufacturers or distributors shall train their purchase and sales staff on drug related laws, regulations and professional knowledge, and establish training records including time, venue, content and trainees.
Article 7 Drug manufacturers or distributors shall strengthen the management of the sales staff and set up specific rules for their sales behaviors.
Article 8 Drug manufacturers or distributors shall not store or spot trade drugs on the premises not approved by the drug regulatory departments.
Article 9 Drug manufacturers shall sell drugs that they produce in the name of themselves, and shall not sell any drug that they produce for contract manufacturing or any drugs produced by others.
Article 10 Where a drug manufacturer or wholesaler sells drugs, it shall provide the following materials:
(1) Copies of the Drug Manufacturing Certificate or Drug Supply Certificate, stamped with the seal of the enterprise, and the business license;
(2) Copies of the approval documents for the drug to be sold, stamped with the seal of the enterprise ;
(3) For import drug sales, relevant proof documents should be provided in accordance with the related provisions of the State.
Where a drug manufacturer or wholesaler sends any of its sales staff to sell drugs, it shall, in addition to the materials prescribed in the previous paragraph of this Article, provide a copy of the authorization letter with the seal of the enterprise.
......