Article 75Anyone violating the provisions in Articles 48, 49, 50, 51 and 52 of the Regulations concerning the control over drug pricing shall be punished according to the relevant provisions in the Pricing Law.

Article 76Where the approved content of a drug advertisement is altered without authorization, the advertiser shall be ordered by the drug regulatory department to discontinue publishing the said advertisement without delay, and punishments shall be given by the original approving drug regulatory department according to the provisions in Article 92 of the Drug Administration Law.

After the drug regulatory department withdraws the drug advertisement approval number, it shall notify the organ in charge of advertising supervision and control of the matter within five working days from the date the administrative decision is made. The organ in charge of advertising supervision and control shall, within 15 working days from the date it receives the notification from the drug regulatory department, make an administrative decision for handling the matter according to the relevant provisions in the Advertisement Law of the People's Republic of China.

Article 77Where any enterprise published a drug advertisement outside the province, autonomous region or municipality directly under the Central Government where the drug manufacturer or import drug agent is located without filing a record with the drug regulatory department of the province, autonomous region or municipality directly under the Central Government where the drug advertisement is published, the drug regulatory department of the province, autonomous region or municipality directly under the Central Government shall order the enterprise to make a rectification within a time limit. If the enterprise fails to make any rectification within the time limit, advertising activities carried out in the place for the said drug shall be discontinued.

Article 78Where the drug regulatory department finds that a drug advertisement is published without approval by the drug regulatory department of the people's government of the province, autonomous region or municipality directly under the Central Government, the drug regulatory department of the people's government of the province, autonomous region or municipality directly under the Central Government shall notify the organ in charge of advertising supervision and control to investigate and handle the matter in accordance with law.

Article 79Where anyone that, in violation of the provisions set forth in the Drug Administration Law and in the Regulations, commits any of the following acts shall be given heavier punishments by the drug regulatory department based on the extent of punishment ser forth in the Drug Administration Law and in the Regulations:

(1) passing narcotics, psychotropic substances, medicinal toxic drugs and radioactive pharmaceuticals off as other drugs or vice versa;

(2) producing or selling counterfeit or substandard drugs of which the main users are pregnant or parturient women, infants and children;

(3) producing or selling biological and blood products which are defined as counterfeit or substandard drugs;

(4) producing, selling or using counterfeit or substandard drugs, thus inducing harmful results to people;

(5) producing, selling or using counterfeit or substandard drugs again after being punished; or

(6) refusing or evading supervision and inspection, or forging, destroying or concealing relevant evidentiary materials, or using sealed and seized articles without authorization.

Article 80Branches of drug regulatory departments shall have the authority to, according to the provisions in the Drug Administration Law and in the Regulations, give administrative sanctions such as warning, fine and confiscation of drugs illegally produced or marketed and illegal gains therefrom.

Article 81Where a drug distributor or medical institution dose not violate the relevant provisions in the Drug Administration Law and in the Regulations and has sufficient evidence to prove its unawareness that the drugs being sold or used are counterfeit or substandard drugs, the said drugs and the illegal gains therefrom shall be confiscated; however, it may be exempted from other administrative punishments.

Article 82Articles confiscated according to the provisions in the Drug Administration Law and in the Regulations shall be dealt with under supervision by drug regulatory departments in accordance with regulations.

Chapter X Supplementary Provisions

Article 83The terms used in the Regulations are defined as follows:

Drug quality attachment and other marks refer to approval documents for drug production, drug testing reports, drug packages, labels and insert sheets.

New drugs refer to the drugs which have not been marketed within the territory of the People's Republic of China.

Prescription drugs refer to the drugs that may only be purchased, dispensed or used with prescriptions by licensed doctors or licensed assistant doctors.

Non-prescription drugs refer to the drugs announced by the drug regulatory department under the State Council which can be purchased or used by consumers upon their own judgment without prescriptions by licensed doctors or licensed assistant doctors.

Pharmaceutical preparations of medical institutions refer to pharmaceutical preparations based on fixed prescriptions which have been dispensed upon approval by medical institutions according to their own clinical needs for their own use.

Drug certification refers to the process through which drug regulatory departments inspect and evaluate the units engaging in research and development, production, distribution or use of drugs as to their compliance with corresponding requirements, and decide on whether to issue the corresponding certificates.

Drug distribution refers to drug wholesale and/or retail.

Scope for drug distribution refers to the category of drugs reviewed and approved for distribution by drug regulatory departments.

Drug wholesalers refer to the drug distributors who sell the purchased drugs to drug manufacturers, drug distributors or medical institutions.

Drug retailers refer to the drug distributors who sell the purchased drugs to consumers directly.

Article 84The term "drugs to be marketed in China for the first time" used in Article 41 of the Drug Administration Law refers to the drugs that are marketed for the first time in China by domestic or foreign drug manufacturers, including the same product manufactured by different drug manufacturers.

Article 85In the second paragraph of Article 59 of the Drug Administration Law, "drug manufacturers, drug distributors or their agents are prohibited from offering, under any pretence, 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", the term "money or things of value or other benefits" refer to the illegitimate benefits provided by drug manufacturers, drug distributors or their agents to leading members, drug purchasers, physicians, or other related persons of the medical institutions for the purpose of influencing their acts in purchasing or prescribing drugs.

Article 86The Regulations shall go into effect as of September 15, 2002.