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Pharmaceutical Administration Law of the People's
双击自动滚屏 文章来源:网上转载   发布者:admin   发布时间:2001-7-28   阅读:11411

 

 @@  Article  28.  Imported medicines must be inspected by the
pharmaceutical  inspection   institutions  authorized  by  the
administrative  department of public health under the State Council;
those having passed the inspection shall be allowed to be imported.
 Medicines  to  be  imported in small quantities for urgent clinical
needs by medical  units  or  for  personal  use shall be handled
according to customs regulations.
 @@ Article 29. The administrative department of health under the
State Council shall have the power to restrict or prohibit the
export of traditional  Chinese  medicinal  materials and prepared
Chinese medicines which are in short supply in the domestic market.
 @@  Article  30.  Import  Licences or Export Licences issued
by  the administrative department of health under the State Council
are required for the import or export of narcotics and psychotropic
substances falling within  the  restricted scope prescribed by the
administrative department of health under the State Council.
 @@  Article  31.  Newly  discovered domestic medicinal plants or
medicinal plants  introduced from abroad may be sold only after
they  have been examined  and  approved  by  the  administrative
department of health of the relevant province, autonomous region,
or municipality directly under the Central Government.
  @@  Article  32.  Measures for controlling medicinal materials
traditionally used  by local people in certain regions shall be
formulated  by the administrative department of health under the State
Council.
 @@  Article  33. The production and sale of fake medicines are
prohibited. A fake medicine has either of the following characteristics:
 (1)  The names of its components are different from those prescribed
for  it  by  state  pharmaceutical  standards  or  pharmaceutical
standards  of  the relevant  province,  autonomous  region,  or
municipality directly under the Central Government;
 (2)  A non-medical substance is passed off as a medicine, or one
medicine is passed off as another.
 A medicine shall be handled as fake medicine in any of the following
cases:
 (1)  Where the use of the medicine has been prohibited by the
administrative department of health under the State Council;
 (2)  Where  the  medicine  produced  without  being  assigned a
registration
number;
(3) Where the medicine has deteriorated and cannot be used as such; or
 (4) Where the medicine has been contaminated and cannot be used as
such.
 @@  Article  34. The production and sale of medicines of inferior
quality shall be prohibited. A medicine of inferior quality has
any of the following characteristics:
 (1)  The  components of the medicine does not conform in quantity
to that required by state pharmaceutical standards or pharmaceutical
standards  of  the  relevant  province,  autonomous  region, or
municipality directly under the Central Government;
(2) The medicine has passed its expire date; or
 (3) The medicine fails to meet the prescribed standards in other
respects.
 @@  Article  35.  Personnel  in  pharmaceutical  producing or
trading enterprises  and  in  medical units, who have direct contact
with  medicines, must  undergo  an  annual  medical  examination.
Persons who have contracted contagious  diseases  or  any other
disease  which  may  contaminate  the medicines  shall  not  be
allowed  to  engage  in any work which has direct contact with
pharmaceuticals.
CHAPTER VI ADMINISTRATION OF PHARMACEUTICALS AT MEDICAL UNITS
  @@  Article  36.  Packaging  must  meet the specific quality
requirements of the  pharmaceuticals and facilitate their storage,
transportation  and medical  use.  If  a medicine has a period of
validity, it must be clearly indicated on the package.
 Traditional  Chinese  medicinal  materials  must  be  packaged
before transportation.  There  must appear on the package the name of
the medicine, place of production, date, name of the consignor, and an
indication showing that the quality of the medicine is up to standard.
 @@  Article  37.  Packages of pharmaceuticals must, in accordance
with the regulations, be labeled and include directions for use.
 The  label  or  directions  must  indicate the name of the
medicine, specifications, the producer, registration number, batch
number  of  the  product,  principal  components,  indications,
directions  for  use dosage, contraindications, adverse reactions and
precautions.
 Special  indications must be printed as required on the labels of
narcotics, psychotropic  substances,  toxic drugs, radioactive drugs
and medicines for external use.
 @@  Article  38.  A pharmaceuticals tr

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