Provisions Governing the Import of Drugs

 1991.01.01



MINISTRY OF PUBLIC HEALTH



PROVISIONS GOVERNING THE IMPORT OF DRUGS



 (Promulgated  on November 2, 1990 by the Ministry of Public Health



of the People's Republic of China)



CONTENTS



CHAPTER I GENERAL PROVISIONS



CHAPTER II REGISTRATION OF IMPORTED DRUGS



CHAPTER III CONTRACTS AND SPECIFICATIONS



CHAPTER IV TESTS



CHAPTER V CLAIMING COMPENSATION



CHAPTER VI PENALTY



CHAPTER VII SUPPLEMENTARY ARTICLE



CHAPTER I GENERAL PROVISIONS



 @@  Article 1. In view to strengthen the management and supervision



of the quality  of  imported drugs to guarantee their safe and



effective uses, this provisions are established according to the "Drug



Administration Law of the People's Republic of China" and related eats,



regulations, and provisions.



 @@  Article  2. The health administrative departments of the State



Council of  the People's Republic of China is the competent authority



for management and  supervision  of  imported  drugs. The health



departments  (bureaux)  of  provinces,  autonomous  regions,  and



municipalities  directly  under  the  central  government  are



responsible for management and supervision of drugs imported in their



own areas.



 @@  Article 3. Imported drugs must undergo official tests conducted



by the Coastal  Institutes  for Drug Control (hereafter referred



as  Coastal Institutes),  which  are  authorized by the Ministry of



Public Health of the People's Republic of China to conduct official



tests for imported drugs on behave of the government.



 And  the National Institute for the Control of Pharmaceutical and



Biological Products  is  responsible  for the technical guidance



for  the  Coastal Institutes and for the adjudication upon disputed



tested results.



 @@  Article  4.  Imported  drugs  must  be  in kinds of safe,



effective, and badly needed in domestic clinical practice.



CHAPTER II REGISTRATION OF IMPORTED DRUGS



 @@  Article  5.  A registration procedure for the import of drugs



has been enacted  by the country. Imported drugs must have the



"registration certificate  for imported drug" issued by the Ministry



of Public Health of the People's Republic of China. The registration



certificate is applicable only to the drug, the country, and the



manufacturer as stated therein.



  In  import  of  drugs  that do not have import registration



certificates but are  of special requirement or short of domestic



supply, the importing units should apply from the Ministry of Public



Health of the People's Republic of China a "single permit for import



of drug". The "permit" is applicable only to the drug, the country,



the manufacturer, the quantities, the terms and the Coastal Institutes



indicated in the permit thereof.



 @@  Article  6.  "Registration  certificate  for imported drug"



should be applied  for by a foreign manufacturer or its agent with an



application form filled-up in duplicate being submitted to the Bureau



of Drug Administration of the Ministry of Public Health with all



data  and  documents as so required. Single permit for import of



drug  for specially wanted drugs should  be  applied for by the



domestic importing units and all the data and documents so required



shall be submitted to the relevant health departments (bureaux) in



the provinces, autonomous regions, or municipalities directly under



the  central  government  for preliminary examination and then be



transferred  to the Bureau of Drugs Administration of the Ministry of



Public Health for approval,



 @@ Article 7. Following data and documents shall be submitted



when applying for a "registration certificate";



 1.  Original  certificate  issued  by  the  authority  of  the



manufacturing country  ratifying the production, sales and export of



the drug concerned as well as GMP inspection report with its Chinese



version;



2. Letters patent;



3. Data sheets and their Chinese versions;



4. Technical informations:



 a.  Formula,  names  (including non-proprietary name, trade name,



chemical name) of active ingredients, auxliaries and preservatives and



dosages;



b. Brief description of its production process;



 c. Specifications and quality control methods of the drug(s) and



their Chinese translations;



  d.  Abstracts  of  Its  pharmacological  and  toxicological



experiments, and their informations on literature;



 e.  Clinical  data,  including  indications,  dosages,  rout



of   its  administration,    adverse    and   side-effects,



contraindications,  and precautions;



f. Data on its stability studies.



5. Samples of the drug(s); and



6. Packaging materials and their samples.



 @@  Article  8. In the application of "registration certificate for



imported drug",  if the attached specifications were standards of the



manufacturer's that  didn't included in the "Pharmacopoeia of the



People's Republic of China" or in the "Provisions of Biological



Products  of  the people's Republic of China" then three batches



of samples should be submitted to Coastal Institute assigned by the



Bureau  of Drug Administration of the Ministry of Public Health for



checking. If results met requirement, the examination shall proceed.



 @@  Article  9.  Drug(s)  imported  for the first time shall be



subject to clinical trials or validations within he territory of China.



 @@ Article 10. "Registration Certificate for Imported Drug" is valid



for 3 years  as  of  its  issuance. Renewal of the registration



certificate may applied for by foreign manufacturer and their agents



six months before its expiration,  and  should be attached with



certificate  issued  by  the manufacturing  country ratifying the



production  and  sales as well as documents such as data sheets



and  specifications, the renewal shall be accepted if the documents



passed examination.



 If  revisions  have made on specifications, production process,



indications, data  sheet,  etc.  the  revised  copies  should be



submitted  in  time by the manufacturer  to the Bureau of Drug



Administration of the Ministry of Public Health for reexamination.



CHAPTER III CONTRACTS AND SPECIFICATIONS



 @@  Article  11. Foreign trade unit deal with imported drugs must



possess "Business  licence  for  handling  drugs"  issued  by the



health departments (bureaux)  and  contract have to be signed with



foreign unit in accordance with  the  provisions.  A copy of the



contract along with reprinted copy of the "registration certificate"



of "single permit for import of drugs" ought to be submitted to the



Coastal Institute within 15 days after signing contract.



 @@  Article  12.  Specifications must specified in the contract



and they should  be  included  in  current  Pharmacopoeia of the



People's Republic of china, Drug Specifications issued by the MPH,



PRC.  or Pharmacopoeias generally  used in international commerce.



Those drugs that didn't contained in phrmacopoeias mentioned above



shall  adopt  specifications  accepted during issuance  of  the



registration  certificate  by  the MPH, PRC. These specifications



should  be  timely submitted to the Coastal Institute by the importing



unit before the drug arriving the port.



 @@  Article  13.  That  special reagents, standard substances, or



reference standard substances needed in tests shall be offered by



the seller and should be distinctly defined in the contract.



CHAPTER IV TESTS



 @@  Article  14. Coastal Institute shall be informed timely by the



importing unit  or receiving agent after the drugs arriving the



port,  and  an "application  form  for tests of imported drugs"



should  be  filled and submitted along with receipt, shipping order



and quality certificate of the drugs  issued by the producer. The



drugs shall be released or provisionally kept for quarantine by the



Customs while the declaration form of the drugs was affixed with the



stamp of acceptance of the Coastal Institute.



 @@  Article  15.  The applicant units should arrange for the



Coastal Institute  for sampling within seven days after the Customs



releases, and samples shall be taken in site in presence of the two



in accordance with "Sampling  Regulations on Imported Drugs" and



"Sampling  Regulations on Imported Medicinal Material". The drug(s)



shall not be allocated, selled, and used by the applicant unit until



certificate of qualify issued by the Coastal Institute has received.



 @@ Article 16. Drugs without "registration certificate for imported



drug" or  "single  permit for import of drugs" and drugs beared no



names, no batch numbers,  or no brande names of the manufacturing



country, their tests shall be refused by the Coastal Institute.



 @@  Article 17. Test should be timely done and the report shall be



issued within 25 days after sampling by the Coastal Institute. When



the testing report could not be issued timely in special condition, an



explanation must be given to the applicant unit in order to extend



the limit for claiming compensation.



 @@  Article 18. The "testing report of imported drugs" issued



by the Coastal Institute should distinctly indicate the results and



conclusion, e.g.  "the drugs met the specifications and allowed to



enter the country" or "the drugs didn't meet the specifications



and not allowed to enter the country". When special situation was



encentered the Coastal Institute ought to consult with the native



health departments (bureaux) for treatment.



While  drugs manufacturing enterprise, drugs handling enterprise,



and medical  institution  purchase imported drugs the drugs importing



unit shall be  asked for offering a copy of the testing report



issued by Coastal Institute.



 Data  sheet  in Chinese shall attach to the imported drug selled on



domestic market.



 @@  Article  19.  If  an  objection on testing result has been



raised, it should  be  put  forward within 90 days from the date



issuing testing report to the Coastal Institute for retesting by the



drugs importing unit, along with reasons and evidences suggested.



If  objection  on retesting result still  exist,  the  National



Institute for the Control of pharmaceutical and Biological Products



should be applied for reexamination on arbitration. All the expenses



on retesting and reexamination on arbitration shall be paid by the



failed side.



 @@  Article  20. The receiving unit may applied for exemption of



examination for  small amount of imported drugs needed in first



aid and research (excluding clinical trial of new drugs) or donated



by foreigner, and the Customs  shall  release the above mention



drugs upon examination-exempted certificate issued by local health



departments  (bureaux).  If  problems  occurred  in  using the



examination-exempted  drugs,  the  receiving unit shall hold  the



responsibility. Small amount of imported drugs for individual use shall



be managed pursuant to the provisions of the Customs.



 The imported drugs mentioned in this article shouldn't be selled on



market.



CHAPTER V CLAIMING COMPENSATION



 @@  Article  21. The Ministry of Public Health, PRC., the National



Institute for the Control of Pharmaceutical and Biological Products,



and the local health  departments (bureaux) should be informed by



the Coastal Institute regarding  testing  report of the products



unqualified and not allowed to import, and other Coastal Institutes



should also be informed; in addition, the report should be issued in



both  Chinese and English and the importing unit  shall  claim



compensation  based  on  it  to  foreign country. The unqualified



drugs  shall  be  properly  kept  by the importing unit, and no



entrance  and  no unauthorized use should be allowed until the



settlement of the  compensation. The Coastal Institute should be



informed timely regarding the outcome of the compensation by written



report.



CHAPTER VI PENALTY



 @@  Article  22.  Manufacturer and handler of imported drugs whose



products have failed to meet standards more than twice shall be



punished from warning, circulating, to withdrawing the registration



certificate, by the Ministry of Public Health of the PRC.



 For  counterfeit,  fake, and adulterated imported imported drugs,



except the samples  reserved for reference by the Coastal Institute,



the balance shall be  confiscated by health departments (bureaux)



and all the "registration certificates for import drugs" owned by



the manufacturer or handler shall be withdrawn by the Ministry of



Public Health of th PRC.



 @@  Article  23.  Those  who dealt with imported drugs without



"Business licence  for handling drugs"; those who engaged in sales or



uses of imported drugs  that  haven't been tested by a Coastal



Institute; those who forged or disguised testing report, certificate



on  testing results or application form for tests; and those who



violated this provisions shall be punished according to the relevant



article of the "Drug Administration Law of the People's Republic of



China" by the local health departments (bureaux).



 Those  who forged or disguised "registration certificate for imported



drugs" shall  be  punished  according  to  relevant  articles of



the  "Drug Administration Law of the People's Republic of China"



in addition to confistication of the fake certificate.



 @@  Article  24.  Based  on  the  seriousness of the situation,



disciplinary action  or criminal responsibility shall be imposed



on  personnel  or investigated staffs working in health department



(bureaux) and in Coastal Institute  by  whom  power was abused,



malpractices were committed out of personal benefit, and duty was



neglected and harmful effect or economic damage was created to the



country.



CHAPTER VII SUPPLEMENTARY ARTICLE



  @@  Article  25.  Charges  on  issuance  of  "registration



certificate  for imported drugs" by the MPH., PRC., and on the



tests and issuance of certificate  to  foreign country by Coastal



Institute shall be collected in accordance with relevant provisions.



  @@   Article  26.  Narcotic  drugs,  psychotropic  drugs,



radiopharmaceuticals shall  be  imported according to "regulations



on  Management of Narcotic drugs",  "Regulations on Management of



Psychotropic  drugs",  and  "Regulations  on  Management  of



Radiopharmaceuticals"  promultigated  by the State Council of the



People's Republic of China.



 @@  Article  27.  Importation  of human serum albumin and blood



preparations specially permitted by MPH., PRC., may only be organized



after approval by the MPH. PRC. based on relevant regulations.



 @@  Article  28.  The phrase "pharmacopoeias generally used in



international commerce"  used  in this provisions refers to "United



States  Pharmacopoeia",  "British   Pharmacopoeia",   "Japanese



Pharmacopoeia"  and  "European Pharmacopoeia".



 @@  Article  29.  The  Ministry of Public Health of the People's



Republic  of China is responsible for the interpretation of the



provisions.



 @@  Article 30. This provisions shall come into force on Jan. 1 of



1991.