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| Category | PUBLIC HEALTH AND MEDICINE | Organ of Promulgation | The State Council | Status of Effect | In Force |
| Date of Promulgation | 1992-10-14 | Effective Date | 1993-01-01 |
|
Regulations on the Protection of Types of Traditional Chinese Medicine |
|---|
Article 1 These Regulations are formulated for the purposes of improving
the quality of types of traditional Chinese medicine, protecting the
legitimate rights and interests of traditional Chinese medicine producing
enterprises, and promoting the development of traditional Chinese medicine.
Article 2 These Regulations apply to types of traditional Chinese
medicine produced and manufactured within the territory of China, including
prepared traditional Chinese medicines, extracts and preparations from natural
medicinal materials, as well as artificial traditional Chinese medicines.
Those types of traditional Chinese medicine for which patents are applied
for shall be dealt with under the provisions of the Patent Law, and not under
these Regulations.
Article 3 The State encourages research and development of types of
traditional Chinese medicine with clinical effects, and practises a
classification protection system for types of traditional Chinese medicine
with reliable quality and certain curative effects.
Article 4 The administrative department of public health under the State Article 5 Types of traditional Chinese medicine under the protection of The protection of types of traditional Chinese medicine shall consist of Article 6 For types of traditional Chinese medicine which conform to any (1) having special curative effects for a certain disease; (2) artificial medicines prepared from varieties of wild medicinal (3) used for the prevention and cure of special diseases. Article 7 For types of traditional Chinese medicine which conform to any (1) conforming to the provisions of Article 6 in these Regulations, or (2) having outstanding curative effects for a certain disease; or (3) effective substances and special preparations extracted from natural Article 8 New medicines approved by the administrative department of Article 9 Procedures for handling applications for the protection of (1) Any traditional Chinese medicine producing enterprise may, if it (2) The State examination and evaluation committee for the protection of (3) Based on the conclusion of the State examination and evaluation The administrative department of public health under the State Council Article 10 Any enterprise applying for protection of types of traditional Article 11 The administrative department of public health under the State Article 12 The period of protection for types of traditional Chinese The period of first class protection is thirty years, twenty years and ten The period of second class protection is seven years. Article 13 Within the period of protection, the prescriptions and Departments, enterprises and units concerned which have the duty to keep Article 14 Transfer to any foreign country of prescriptions and Article 15 Where, due to special circumstances, it is necessary to extend Article 16 The period of protection of types of traditional Chinese If it is necessary to extend the period of protection of a type of Article 17 The production of protected types of traditional Chinese Article 18 Where more than one enterprises produce a type of traditional (1) If it is up to the national pharmaceutical standards, the Certificate (2) If it is below the national pharmaceutical standards, the registered Article 19 For protected types of traditional Chinese medicine in short Article 20 Enterprises producing protected types of traditional Chinese Article 21 Registration of protected types of traditional Chinese Article 22 If anyone divulges secrets in violation of the provisions of Article 23 If anyone, in violation of the provisions of Article 17 of If anyone fabricates the Certificate of Protection of Types of Traditional If the aforesaid acts have constituted crimes, the judicial organs shall Article 24 A party who refuses to accept the decision of punishment made Article 25 Requirements and application forms for the protection of types Article 26 The administrative department of public health under the State Article 27 These Regulations shall come into effect on January 1, 1993.
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Council shall be responsible for the supervision and control of the protection
of types of traditional Chinese medicine throughout the country. The State
competent authority for the production and trading of traditional Chinese
medicine shall assist the administrative department with the control of the
protection of types of traditional Chinese medicine throughout the country.
Chapter II Classification and Approval for the Protection of Types of
Traditional Chinese Medicine
these Regulations must be those listed in the national pharmaceutical
standards. Upon the determination of the administrative department of public
health under the State Council, protection of types of traditional Chinese
medicine listed in the pharmaceutical standards of provinces, autonomous
regions and municipalities directly under the Central Government may be
applied for.
first class protection and second class protection.
of the following conditions, first class protection may be applied for.
materials analogously under first class protection; or
of the following conditions, second class protection may be applied for.
having once been listed under first class protection but now being cancelled;
medicinal materials.
public health under the State Council shall be protected within a period of
protection as described by the administrative department. For those of them
which conform to the provisions of Article 6 or 7 in these Regulations, an
application for the renewal of the protection may, six months before the
expiration date of protection approved by the administrative department of
public health under the State Council, be offered according to the provisions
of these Regulations.
types of traditional Chinese medicine are as follows:
thinks that the type of traditional Chinese medicine it produces conforms to
the provisions of Article 5, 6, 7 or 8 in these Regulations, apply for
protection with the local competent authority for the production and trading
of traditional Chinese medicine in the province, autonomous region or
municipality directly under the Central Government. The local competent
authority for the production and trading of traditional Chinese medicine shall
write down its comments on the application, then transmit it to the
administrative department of public health at the same level, which shall make
a preliminary examination and write down its comments and submit the
application, with comments, to the administrative department of public health
under the State Council. Under special circumstances, a traditional Chinese
medicine producing enterprise may directly apply to the State competent
authority for the production and trading of traditional Chinese medicine which
shall write down comments on the application and transmit it to the
administrative department of public health under the State Council, or may
directly apply to the administrative department of public health under the
State Council.
types of traditional Chinese medicine shall, under the authorization of the
administrative department of public health under the State Council, be
responsible for the examination and evaluation of the types of traditional
Chinese medicine for which the protection is applied for. The committee shall
provide an examination and evaluation conclusion within six months as of the
date of receiving an application.
committee for the protection of types of traditional Chinese medicine, the
administrative department of public health under the State Council shall, in
consultation with the State competent authority for the production and trading
of traditional Chinese medicine, decide whether or not to grant the protection
thereto. For the types of traditional Chinese medicine of which the protection
has been approved, the administrative department of public health under the
State Council shall issue a Certificate of Protection of Types of Traditional
Chinese Medicine.
shall be responsible for the formation of the State examination and evaluation
committee for the protection of types of traditional Chinese medicine, members
of which shall, in consultation with the State competent authority for the
production and trading of traditional Chinese medicine, be appointed from
experts in the field of medical service, scientific research, inspection, as
well as trading and management of traditional Chinese medicine.
Chinese medicine shall provide the State examination and evaluation committee
for the protection of types of traditional Chinese medicine with complete sets
of materials as required by the administrative department of public health
under the State Council.
Council shall make announcements in the designated professional newspapers and
periodicals regarding the types of traditional Chinese medicine to which
protection has been granted or those for which the period of protection has
expired.
Chapter III Protection of Protected Types of Traditional Chinese Medicine
medicine is as follows:
years respectively.
pharmaceutical techniques of types of traditional Chinese medicine under first
class protection shall be kept secret and shall not be published by the
producing enterprises having been granted the Certificate of Protection of
Types of Traditional Chinese Medicine, the competent authorities for the
production and trading of traditional Chinese medicine, the administrative
departments of public health, and other units or individuals concerned.
secrets shall set up necessary security systems as required by the State.
pharmaceutical techniques of types of traditional Chinese medicine under first
class protection shall be dealt with according to the relevant State
provisions of security.
the period of protection of a type of traditional Chinese medicine under first
class protection, the producing enterprise shall, six months before the
expiration date of protection, submit an application for extension according
to the procedures described in the Article 9 of these Regulations. The
extended period of protection shall be decided by the State examination and
evaluation for the protection of types of traditional Chinese medicine,
however, an extension approved each time shall not exceed the period of
protection granted for the first time.
medicine under second protection may be extended for seven years upon
expiration.
traditional Chinese medicine under second class protection, the producing
enterprise shall, six months before the expiration date of protection, submit
an application for extension according to the procedures described in the
Article 9 of these Regulations.
medicine within the period of protection shall be restricted to enterprises
which have been granted the Certificate of Protection of Types of Traditional
Chinese Medicine, unless otherwise provided for in Article 19 of these
Regulations.
Chinese medicine under protection before the protection is granted by the
administrative department of public health under the State Council, those
enterprises who have not applied for the Certificate of Protection of Types of
Traditional Chinese Medicine shall, within six months as of the date of
announcement, report the case to the administrative department of public
health under the State Council and provide relevant materials according to the
provisions of Article 10 of these Regulations. The administrative department
of public health under the State Council shall designate a pharmaceutical
inspection institution to inspect the quality of the reported type of medicine
as has been done with the type under protection. Based on the inspection, the
administrative department of public health under the State Council may take
the following measures:
of Protection of Types of Traditional Chinese Medicine shall be issued through
consultation with the State competent authority for the production and trading
of traditional Chinese medicine.
document of approval of this type of traditional Chinese medicine shall be
revoked according to the laws and regulations governing pharmaceutical
administration.
supply for clinical needs, the administrative departments of public health in
provinces, autonomous regions and municipalities directly under the Central
Government shall, as proposed by the State competent authority for the
production and trading of traditional Chinese medicine, and with the approval
of the administrative department of public health under the State Council,
issue registered documents of approval to the enterprises which produce in
their localities the same types of traditional Chinese medicine as the
protected types for imitation. The imitation enterprises shall pay reasonable
use fees to the enterprises who hold the Certificate of Protection of Types of
Traditional Chinese Medicine and transfer the prescriptions and pharmaceutical
techniques of the protected types. The amounts of the use fees shall be
decided by the two sides through consultation. If the two sides fail to reach
an agreement, the administrative department of public health under the State
Council shall make a ruling.
medicine and the competent authorities for the production and trading of
traditional Chinese medicine shall improve conditions of production and the
qualities of the protected types as required by the administrative departments
of public health in provinces, autonomous regions and municipalities directly
under the Central Government.
medicine within the period of protection in any foreign country shall be
subject to the approval of the administrative department of public health
under the State Council.
Chapter IV Penalties
Article 13 of these Regulations, the unit to which he belongs or the higher
authority shall impose upon him disciplinary sanctions. If a crime has been
constituted, criminal liability shall be investigated according to laws.
these Regulations, imitates a protected type of traditional Chinese medicine
without approval, the administrative departments of public health at or above
the county level shall punish him as a producer of fake medicines.
Chinese Medicine and relevant certification documents to produce and sell
medicines, the administrative departments of public health at or above the
county level shall confiscate all medicines involved and illegal gains, and
may concurrently fine him not more than three times the prices of the standard
equivalents of medicines involved.
investigate for criminal liabilities.
by the administrative departments of public health may apply for
administrative reconsideration or institute administrative proceedings
according to the relevant provisions of laws and administrative regulations.
Chapter V Supplementary Provisions
of traditional Chinese medicine shall be decided by the administrative
department of public health under the State Council.
Council shall be responsible for the interpretation of these Regulations.
URL: http://www.asianlii.org/cn/legis/cen/laws/rotpototcm652