【正文】 e said departments, and may not release those drugs for which no Drug Import Note is issued. The drug regulatory department in the place where the port is located shall notify the drug testing institution to conduct sampling and testing of the drugs to be imported according to the regulations of the drug regulatory department under the State Council, and sampling fees shall be charged in accordance with the provisions of the second paragraph of Article 41 of this Law. The ports where drugs may be imported shall be proposed by the drug regulatory department under the State Council together with the General Customs Administration and submitted to the State Council for approval. Article 41 The drug regulatory department under the State Council shall designate drug testing institutions to test the following drugs before they are marketed or at the time they are imported。 (2)drugs to be marketed in China for the first time。 it shall withdraw the approval number or Import Drug License issued to drugs with uncertain therapeutic efficacy, serious adverse reaction, or other factors harmful to human health. No drugs whose Approval Numbers or Import Drug Licenses have been withdrawn may be produced, distributed or used. Those already produced or imported shall be destroyed or disposed of under the supervision of the local drug regulatory department. Article 43 The State adopts a system for drug reserve. When major disasters, epidemic situations or other emergencies occur in the country, the department specified by the State Council may transfer drugs from the enterprises to meet the urgent needs. Article 44 The State Council shall have the power to restrict or prohibit the exportation of the drugs which are in short supply within the country. Article 45 Anyone who wishes to import or export narcotic drugs and psychotropic substances that fall within the scope specified by the State shall produce the Import License or Export License issued by the drug regulatory department under the State Council. Article 46 The newlydiscovered crude drugs or cultivated crude drugs introduced from abroad may be marketed only after examination and approval by the drug regulatory department under the State Council. Article 47 Measures for the control over the folk crude drugs customarily used in certain regions shall be formulated by the drug regulatory department together with the administrative department for traditional Chinese medicines under the State Council.
Article 48 Production (including dispensing, the same below) and distribution of counterfeit drugs are prohibited. A drug is a counterfeit drug in any of the following cases: (1) the ingredients in the drug are different from those specified by the national drug standards。 (2)it is produced or imported without approval, or marketed without being tested, as required by this Law。 (4)it is contaminated。 or (6)the indications or functions indicated are beyond the specified scope. Article 49 Production and distribution of substandard drugs are prohibited. A drug with content not up to the national drug standards is a substandard drug. A drug shall be treated as a substandard drug in any of the following cases: (1) the date of expiry is not indicated or is altered。 (3) it is beyond the date of expiry。 (5) colorants, preservatives, spices, flavorings or other excipients are added without authorization。s Republic of China and on the basis of average social cost, supply and demand on the market, and public affordability, rationally fix and adjust the prices, in order to ensure that price is mensurate with quality, eliminate excessively high price, and protect the legitimate interests of users. Drug manufacturers, drug distributors and medical institutions shall implement prices fixed or guided by the government. No one may raise prices in any manner without authorization. Drug manufacturers shall provide the truthful manufacturing and operation cost to the petent pricing department of the government. No one may refuse to or falsely or deceptively report the cost. Article 56 For drugs the prices of which are adjustable with the market according to law, drug manufacturers, drug distributors and medical institutions shall fix the prices on the principles of fairness, rationality，good faith and mensuration of price with quality, in order to provide the users with drugs of reasonable prices. When fixing and indicating retailing prices, drug manufacturers, drug distributors and medical institutions shall abide by the regulations on control over drug prices formulated by the petent pricing department under the State Council. Usurious profits and fraud in pricing that harms the users39。 and the medical institutions designated by medical insurance provider shall truthfully publicize the prices of drugs in mon use in pliance with the specified measures, in order to ensure reasonable use of drugs. Specific measures shall be formulated by the administrative department for health under the State Council. Article 59 Drug manufacturers, drug distributors and medical institutions are prohibited from offering or accepting, in private, offthebook rakeoffs or other benefits in the course of purchasing and selling drugs. Drug manufacturers, drug distributors or their agents are prohibited from offering, under any pretences, money or things of value or other benefits to leading members, drug purchasers, physicians, or other related persons of the medical institutions where their drugs are used. Leading members of medical institutions, drug purchasers, physicians, or other related persons, on their part, are prohibited from accepting, under any pretences, money or things of value or other benefits offered by drug manufacturers and drug distributors or their agents. Article 60 Drug advertisements shall be subject to approval by the drug regulatory department of the people