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Pharmaceutical Administration Law of the People's
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1985.07.01
STANDING COMMITTEE OF THE NATIONAL PEOPLE'S CONGRESS
PHARMACEUTICAL ADMINISTRATION LAW OF THE PEOPLE'S REPUBLIC OF CHINA
 (Adopted at the Seventh Meeting of the Standing Committee of the
Sixth National  People's Congress and promulgated by Order No. 18 of
the President of  the  People's  Republic of China on September 20,
1984, and effective as of July 1, 1985)
CONTENTS
CHAPTER I GENERAL PROVISIONS
CHAPTER II ADMINISTRATION OF PHARMACEUTICAL PRODUCING ENTERPRISES
CHAPTER III ADMINISTRATION OF PHARMACEUTICAL TRADING ENTERPRISES
CHAPTER IV ADMINISTRATION OF PHARMACEUTICALS AT MEDICAL UNITS
CHAPTER V PHARMACEUTICAL ADMINISTRATION
CHAPTER VI PACKAGING AND REPACKAGING OF PHARMACEUTICALS
CHAPTER VII PHARMACEUTICALS UNDER SPECIAL CONTROL
  CHAPTER   VIII   ADMINISTRATION   OF   TRADEMARKS   AND
ADVERTISEMENTS OF PHARMACEUTICALS
CHAPTER IX SUPERVISION OVER PHARMACEUTICALS
CHAPTER X LEGAL RESPONSIBILITY
CHAPTER XI SUPPLEMENTARY PROVISIONS
CHAPTER I GENERAL PROVISIONS
 @@  Article  1.  This  Law  is  formulated  with  a  view to
enhancing  the  supervision   and  control  of  pharmaceuticals,
ensuring  their  quality,  improving  their  curative  effects,
guaranteeing  safety in medication and safeguarding the health of the
people.
 @@ Article 2. The administrative department of health under the
State Council  shall  be  responsible  for the supervision and
control of pharmaceuticals throughout the country.
 @@  Article  3.  The  state  shall  develop  both modern and
traditional medicines  and  give full play to their role in the
prevention and treatment of diseases and in health care.
 The  state  shall  protect  the  resources  of  wild medicinal
materials and encourage the domestic cultivation of Chinese traditional
medicinal crops.
CHAPTER II ADMINISTRATION OF PHARMACEUTICAL PRODUCING ENTERPRISES
 @@  Article  4.  The  establishment of a pharmaceutical producing
enterprise must  be  sanctioned  by the competent authorities for
the production and trading  of  pharmaceuticals  of the province,
autonomous  region,  or municipality  directly  under the Central
Government in which the enterprise is located, and approved by the
administrative department of health of the same province, autonomous
region  or  municipality,  which  will  issue a Pharmaceuticals
Producer  Licence.  The  administrative  authorities  for industry
and  commerce shall not issue business licences to any enterprises
producing pharmaceuticals without the Pharmaceutical Producer Licence.
The Pharmaceutical Producer Licence shall have a period of validity,
upon expiration  of  which a new licence shall be issued after an
examination for its  renewal. Detailed measures for the renewal of
such licences shall be stipulated by the administrative department
of health under the State Council.
  @@  Article  5.  To  establish  a  pharmaceutical  producing
enterprise, the following requirements must be met:
 (1)  It shall be staffed with the necessary personnel required for
producing the  medicines concerned, that is, pharmacists or technical
personnel  with a qualification  equivalent  to  or  higher than
assistant engineer as well as skilled workers.
 If  an enterprise processing Chinese traditional medicines into
ready-to-use mixture  and  powder forms does not have pharmacists or
technical personnel with  a  qualification equivalent to or higher
than assistant engineer, it shall be staffed instead with skilled
pharmaceutical  workers  who are familiar with the properties of the
medicines  processed  and  are registered with the administrative
department of health at or above the county level.
 (2)  It  shall  have factory premises, facilities and a sanitary
environment suitable for the medicines produced.
 (3)  It  shall  have a unit or competent personnel capable of
inspecting the quality  of  the  medicines  produced,  as well as
necessary instruments and equipment.
 @@  Article  6.  Pharmaceuticals must be produced in accordance
with the technological  procedure, and the record of production must
be complete and accurate.
 The  process  for  preparing  traditional  Chinese medicines in
ready-to-use forms must conform to the Pharmacopoeia of the People's
Republic of China or  the  Processing  Norms  stipulated  by the
administrative departments of health of the provinces, autonomous
regions, or municipalities directly under the Central Government.
 @@  Article  7.  The raw and supplementary materials used for the
production of  pharmaceuticals and containers and packaging materials
in direct contact with pharmaceuticals must conform to the requirements
for medicinal use.
 @@  Article 8. Pharmaceuticals must 

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