Article 61 No fees may be charged for selective drug sampling and testing.
Where the party has any objection to the results of testing conducted by the drug testing institution and applies for re-testing, it shall pay in advance the fees for drug testing to the drug testing institution responsible for the re-testing according to the provisions of the drug regulatory department under the State Council or of the drug regulatory department of the people’s government of the province, autonomous region or municipality directly under the Central Government. If the results of re-testing are inconsistent with the original testing results, the fees for the re-testing shall be paid by the original testing institution.
Article 62 Fees may be collected for certificate issuance, drug registration, drug certification, drug testing for approval and mandatory drug testing according to the provisions in the Drug Administration Law and in the Regulations. The specific standards for collecting fees shall be formulated by the finance department under the State Council and the competent pricing department under the State Council.
Chapter IV Legal Liabilities
Article 63 A drug manufacturer or distributor shall be punished by the drug regulatory department according to the provisions in Article 79 of the Drug Administration Law under any of the following circumstances:
(1) where any newly-established drug manufacturer or any manufacturer with a newly-built workshop or with newly-added dosage forms fails in the GMP certification within the time limit prescribed by the drug regulatory department under the State Council but is still engaged in drug production.
(2) where any newly-established drug distributor fails in GSP certification within the time limit prescribed by the drug regulatory department under the State Council but is still engaged in drug distribution.
Article 64 Any contract giver or acceptor, in violation of the provisions in Article 13 of the Drug Administration Law, giving or accepting the contract for drug production without authorization shall be punished in accordance with the provisions in Article 74 of the Drug Administration Law.
Article 65 Where, without approval, anyone who sets up a store to sell drugs at the town or country fairs, or sells drugs in a store at the fairs beyond the approved scope of drug distribution, shall be punished according to the provisions in Article 73 of the Drug Administration Law.
Article 66 Any medical institution that uses pharmaceutical preparations dispensed by other medical institutions without approval shall be punished according to the provisions in Article 80 of the Drug Administration Law.
Article 67 Any out-patient department, clinic or any other medical institution, which is set up by individuals, if providing patients with drugs beyond the defined scope or kinds of drugs, shall be punished according to the provisions in Article 73 of the Drug Administration Law.
Article 68 Any medical institution that uses counterfeit and substandard drugs shall be punished according to the provisions in Article 74 and 75 of the Drug Administration Law.
Article 69 Any institution, in violation of the provisions in Article 29 of the Drug Administration Law, conducting a drug clinical trial without approval shall be punished according to the provisions in Article 79 of the Drug Administration Law.
Article 70 Where an applicant, in applying for conducting a drug clinical trail, submits false data on drug production procedures, quality specifications, or results of pharmacological and toxicological studies, etc., or submits fraud samples, the drug regulatory department under the State Council shall disapprove the application and give a warning to the applicant; where the circumstances are serious, no application for clinical trial of the said drug submitted by the said applicant may be accepted within three years.
Article 71 Where anyone producing prepared slices of Chinese crude drugs without the national drug standard fails to comply with the processing procedures formulated by the drug regulatory department of the people’s government of the province, autonomous region or municipality directly under the Central Government, or any medical institution dispensing pharmaceutical preparations fails to comply with the standards approved by the drug regulatory department of the people’s government of the province, autonomous region or municipality directly under the Central Government, punishment shall be imposed thereupon according to the provisions in Article 75 of the Drug Administration Law.医学全在线www.med126.com
Article 72 Where the drug regulatory department and its staff members, in violation of regulations, release undisclosed experimental data or other materials submitted by a manufacturer or seller for obtaining approval of production or marketing of a drug containing new chemical entities, thus resulting in losses to the applicant, the drug regulatory department shall be liable for compensation in accordance with law. After compensating the losses, the drug regulatory department shall order the staff members who disclose the said data in purpose or have serious negligence to partially or fully bear the compensation and shall also impose administrative sanctions on those who are directly liable therefor.
Article 73 Any drug manufacturer or distributor producing or distributing drugs or any medical institution dispensing pharmaceutical preparations, whose package, labels or inset sheets are in violation of the provisions in the Drug Administration Law and in the Regulations, shall be punished according to the provisions in Article 86 of the Drug Administration Law.
Article 74 Any drug manufacturer, distributor or medical institution altering any items licensed for manufacturing, distributing, or dispensing drugs without completing the formalities for registration of alteration as required shall be given a warning by the original certificate-issuing department and be ordered to complete the said formalities within a time limit. Its Drug Manufacturing Certificate, Drug Distribution Certificate or Pharmaceutical Preparation Certificate for Medical Institution shall be announced as nullified if it fails to do so within the time limit, and punishment shall be given according to the provisions in Article 73 of the Drug Administration Law if it continues its production and distribution activities.
Article 75 Anyone violating the provisions in Article 48, 49, 50, 51 or 52 of the Regulations concerning the control over drug pricing shall be punished according to the relevant provisions in the Pricing Law.
Article 76 Where 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 punishment 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 matting according to the relevant provisions in the Advertisement Law of the People’s Republic of China.
Article 77 Where any enterprise published a drug advertisement outside the province, autonomous region or municipality directly under the Central Government where the drug manufacturer or drug import agency 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 the 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 78 Where 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 shall notify the organ in charge of advertising supervision and control to investigate and handle the matter in accordance with law.
Article 79 Where anyone that, in violation of the provisions in the Drug Administration Law and in the Regulations, commits any of the following acts shall be given heavier punishment by the drug regulatory department based on the extent of punishment 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 and 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 80 Branches of drug regulatory departments shall have the authority to, according to the provisions in the Drug Administration Law and in the Regulations, give administrative punishments such as warning, fine and confiscation of drugs illegally produced or marketed and illegal gains therefrom.
Article 81 Where 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 illegal gains therefrom shall be confiscated; however, it may be exempted from other administrative punishments.
Article 82 Articles 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 provisions.
Chapter X Supplementary Provisions
Article 83 The 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 assistance doctors.
Pharmaceutical preparations in 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 the drug regulatory department inspects and evaluates the units engaging in research and development, production, distribution or use of drugs as to their compliance with corresponding requirements, and decides 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 the drug regulatory department.
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 84 The 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 firs time in China by domestic or foreign drug manufacturers, including the same product manufactured by different drug manufacturers.
Article 85 In 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 86 The Regulations shall go into effect as of September 15, 2002.
