Decree of the President of the People’s Republic of China No. 3
I hereby promulgate the Basic Law of the Macao Special Administrative Region of the People’ s Republic of China, including Annex I,
Method for the Selection of the Chief Executive of the Macao Special Administrative Region, Annex II, Method for the Formation of
the Legislative Council of the Macao Special Administrative Region, Annex m National Laws to Be Applied in the Macao Special Administrative
Region, and designs of the regional flag and regional emblem of the Macao Special Administrative Region, which was adopted at the
First Session of the Eighth National People’ s Congress of the People ‘ s Republic of China on 31 March 1993 and shall be put into
effect as of 20 December 1999.
Jiang Zemin
President of the People’s Republic of China
31 March 1993
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Preamble
Chapter I General Principles
Chapter II Relationship between the Central Authorities and the Macao Special Administrative Region
Chapter III Fundamental Rights and Duties of the Residents
Chapter IV Political Structure
Section 1 The Chief Executive
Section 2 The Executive Authorities
Section 3 The Legislature
Section 4 The Judiciary
Section 5 Municipal Organs
Section 6 Public Servants
Section 7 Swearing Allegiance
Chapter V Economy
Chapter VI Culture and Social Affairs
Chapter VII External Affairs
Chapter VIII Interpretation and Amendment of the Basic Law
Chapter IX Supplementary Provisions
Annex I Method for the Selection of the Chief Executive of the Macao Special Administrative Region
Annex 11 Method for the Formation of the Legislative Council of the Macao Special Administrative Region
Annex III National Laws to Be Applied in the Macao Special Admrnistrative Region
Decision of the National People’s Congress on the Basic Law of the Macao Special Administrative Region of the People s Republic of
China
Decision of the National People’s Congress on the Establishment of the Macao Special Administrative Region of the People s Republic
of China
Decision of the National People s Congress on the Method for the Formation of the First Government, the First Legislative Council
and the First Judiciary of the Macao Special Administrative Region
Decision of the National People’s Congress on Approving the Proposal by the Drafting Committee for the Basic Law of the Macao Special
Administrative Region on the Establishment of the Committee for the Basic Law of the Macao Special Administrative Region under the
Standing Committee of the National People’s Congress
Appendix
Proposal by the Drafting Committee for the Basic Law of the Macao Special Administrative Region on the Establishment of the Committee
for the Basic Law of the Macao Special Administrative Region under the Standing Committee of the National People’s Congress
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Preamble
Macao, including the Macao Peninsula, Taipa Island and Coloane Island, has been part of the territory of China since ancient times;
it was gradually occupied by Portugal after the mid-16th century. On 13 April 1987, the Chinese and Portuguese Governments signed
the Joint Declaration on the Question of Macao, affirming that the Government of the People’ s Republic of China will resume the
exercise of sovereignty over Macao with effect from 20 December 1999, thus fulfilling the long-cherished common aspiration of the
Chinese people for the recovery of Macao.
Upholding national unity and territorial integrity, contributing to social stability and economic development, and taking account
of its history and realities, the People’ s Republic of China has decided that upon China’s resumption of the exercise of sovereignty
over Macao, a Macao Special Administrative Region will be established in accordance with the provisions of Article 31 of the Constitution
of the People’s Republic of China, and that under the principle of ” one country, two systems”, the socialist system and policies
will not be practised in Macao. The basic policies of the People’s Republic of China regarding Macao have been elaborated by the
Chinese Government in the Sino-Portuguese Joint Declaration .
In accordance with the Constitution of the People’ s Republic of China, the National People’ s Congress hereby enacts the Basic Law
of the Macao Special Administrative Region of the People’ s Republic of China, prescribing the Systems to be practised in the Macao
Special Administrative Region, in order to ensure the implementation of the basic policies of the Peoples Republic of China regarding
Macao.
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Chapter I
General Principles
Article 1
The Macao Special Administrative Region is an inalienable part of the People’s Republic of China.
Article 2
The National People’ s Congress authorises the Macao Special Administrative Region to exercise a high degree of autonomy and enjoy
executive, legislative and independent judicial power, including that of final adjudication, in accordance with the provisions of
this Law.
Article 3
The executive authorities and legislature of the Macao Special Administrative Region shall be composed of permanent residents of Macao
in accordance with the relevant provisions of this Law.
Article 4
The Macao Special Administrative Region shall safeguard the rights and freedoms of the residents of the Macao Special Administrative
Region and of other persons in the Region in accordance with law.
Article 5
The socialist system and policies shall not be practised in the Macao Special Administrative Region, and the previous capitalist system
and way of life shall remain unchanged for 50 years .
Article 6
The right of private ownership of property shall be protected by law in the Macao Special Administrative Region.
Article 7
The land and natural resources within the Macao Special Administrative Region shall be State property, except for the private land
recognised as such according to the laws in force before the establishment of the Macao Special Administrative Region. The Government
of the Macao Special Administrative Region shall be responsible for their management, use and development and for their lease or
grant to individuals or legal persons for use or development. The revenues derived therefrom shall be exclusively at the disposal
of the government of the Region.
Article 8
The laws, decrees, administrative regulations and other normative acts previously in force in Macao shall be maintained, except for
any that contravenes this Law, or subject to any amendment by the legislature or other relevant organs of the Macao Special Administrative
Region in accordance with legal procedures.
Article 9
In addition to the Chinese language, Portuguese may also be used as an official language by the executive authorities legislature
and judiciary of the Macao Special Administrative Region .
Article 10
Apart from displaying the national flag and national emblem of the People’s Republic of China, the Macao Special Administrative Region
may also use a regional flag and regional emblem.
The regional flag of the Macao Special Administrative Region is a green flag with five stars, lotus flower, bridge and sea water.
The regional emblem of the Macao Special Administrative Region is composed of five stars, lotus flower, bridge and sea water encircled
by the words “Macao Special Administrative Region of the People’s Republic of China” in Chinese and “MACAO” in Portuguese.
Article 11
In accordance with Article 31 of the Constitution of the People’s Republic of China, the systems and policies practised in the Macao
Special Administrative Region, including the social and economic systems, the system for safeguarding the fundamental rights and
freedoms of its residents, the executives legislative and judicial systems, and the relevant policies, shall be based on the provisions
of this Law.
No law, decree, administrative regulations and normative acts of the Macao Special Administrative Region shall contravene this Law.
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Chapter II
Relationship between the Central Authorities and the Macao Special Administrative Region
Article 12
The Macao Special Administrative Region shall be a local administrative region of the People’s Republic of China, which shall enjoy
a high degree of autonomy and come directly under the Central People’s Government.
Article 13
The Central People’s Government shall be responsible for the foreign affairs relating to the Macao Special Administrative Region.
The Ministry of Foreign Affairs of the People’s Republic of China shall establish an office in Macao to deal with foreign affairs
.
The Central People’s Government authorizes the Macao Special Administrative Region to conduct relevant external affairs, on its own,
in accordance with this Law.
Article 14
The Central People’s Government shall be responsible for the defence of the Macao Special Administrative Region.
The Government of the Macao Special Administrative Region shall be responsible for the maintenance of public order in the Region.
Article 15
The Central People’s Government shall appoint or remove the Chief Executive, the principal officials of the government and the Procurator
General of the Macao Special Administrative Region in accordance with the relevant provisions of this Law.
Article 16
The Macao Special Administrative Region shall be vested with executive power. It shall, on its own, conduct the administrative affairs
of the Region in accordance with the relevant provisions of this Law.
Article 17
The Macao Special Administrative Region shall be Yested with legislative power.
Laws enacted by the legislature of the Macao Special Administrative Region must be reported to the Standing Committee of the National
People’s Congress for the record. The reporting for record shall not affect the entry into force of such laws.
If the Standing committee of the National People ‘ s Congress, after consulting the Committee for the Basic Law of the Macao Special
Administrative Region under it, considers that any law enacted by the legislature of the Region is not in conformity with the provisions
of this Law regarding affairs within the responsibility of the Central Authorities or regarding the relationship between the Central
Authorities and the Region, the Standing Committee may return the law in question but shall not amend it. Any law returned by the
Standing Committee of the National People’s Congress shall immediately be invalidated. This invalidation shall not have retroactive
effect, unless otherwise provided for in the laws of the Region.
Article 18
The laws in force in the Macao Special Administrative Region shall be this Law, the laws previously in force in Macao as provided
for in Article 8 of this Law, and the laws enacted by the legislature of the Region.
National laws shall not be applied in the Macao Special Administrative Region except for those listed in Annex m to this Law. The
laws listed therein shall be applied locally by way of promulgation or legislation by the Region.
The Standing Committee of the National People ‘ s Congress may add to or delete from the list of laws in Annex m after consulting
its Committee for the Basic Law of the Macao Special Administrative Region and the government of the Region. Laws listed in Annex
m to this Law shall be confined to those relating to defence and foreign affairs as well as other matters outside the limits of the
autonomy of the Region as specified by this Law.
In the event that the Standing Committee of the National People’s Congress decides to declare a state of war or, by reason of turmoil
within the Macao Special Administrative Region which endangers national unity or security and is beyond the control of the government
of the Region, decides that the Region is in a state of emergency, the central People ‘ s Government may issue an order applying
the relevant national laws in the Region.
Article 19
The Macao Special Administrative Region shall be vested with independent judicial power, including that of final adjudication.
The courts of the Macao Special Administrative Region shall have jurisdiction over all cases in the Region, except that the restrictions
on their jurisdiction imposed by the legal system and principles previously in force in Macao shall be maintained.
The courts of the Macao Special Administrative Region shall have no jurisdiction over acts of state such as defence and foreign affairs.
The courts of the Region shall obtain a certificate from the Chief Executive on questions of fact concerning acts of state such as
defence and foreign affairs whenever such questions arise in the adjudication of cases. This certificate shall be binding on the
courts. Before issuing such a certificate, the Chief Executive shall obtain a certifying document from the Central People’s Government.
Article 20
The Macao Special Administrative Region may enjoy other powers granted to it by the National People’s Congress, the Standing Committee
of the National People’s Congress or the Central People’s Government.
Article 21
Chinese citizens who are residents of the Macao Special Administrative Region shall be enpost_titled to participate in the management of
state affairs according to law. In accordance with the assigned number of seats and the selection method specified by the National
People’s Congress, the Chinese citizens among the residents of the Macao Special Administrative Region shall locally elect deputies
of the Region to the National People’s Congress to participate in the work of the highest organ of state power.
Article 22
No department of the Central People’s Government and no province, autonomous region, or municipality directly under the Central Government
may interfere in the affairs which the Macao Special Administrative Region administers, on its own, in accordance with this Law.
If there is a need for departments of the Central Government, or for provinces, autonomous regions, or municipalities directly under
the Central Government to set up offices in the Macao Special Administrative Region, they must obtain the consent of the government
of the Region and the approval of the Central People’s Government.
All offices set up in the Macao Special Administrative Region by departments of the Central Government, or by provinces, autonomous
regions, or municipalities directly under the Central Government, and the personnel of these offices shall abide by the laws of the
Region.
For entry into the Macao Special Administrative Region, people from other provinces, autonomous regions or municipalities directly
under the Central Government must apply for approval. Among them, the number of persons who enter the Region for the purpose of settlement
shall be determined by the competent authorities of the Central reopen Region . The Macao Special Administrative Region may establish
an office in Beijing.
Article 23
The Macao Special Administrative Region shall enact laws, on its own, to prohibit any act of treason, secession, sedition, subversion
against the Central People’s Government, or theft of state secrets, to prohibit foreign political organizations or bodies from conducting
political activities in the Region, and to prohibit political organizations or bodies of the Region from establishing ties with foreign
political organisations or bodies.
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Chapter III
Fundamental Rights and Duties of the Residents
Article 24
Residents Of the Macao Special Administrative Region (“Macao residents”) shall include permanent residents and non-permanent residents.
The permanent residents of the Macao Special Administrative Region shall be:
(1) Chinese citizens born in Macao before or after the establishment of the Macao Special Administrative Region and their children
of Chinese nationality born outside Macao;
(2) Chinese citizens who have ordinarily resided in Macao for a continuous period of not less than seven years before or after the
establishment of the Macao Special Administrative Region and their children of Chinese nationality born outside Macao after they
have become permanent residents;
(3) The Portuguese who were born in Macao and have taken Macao as their place of permanent residence before or after the establishment
of the Macao Special Administrative Region;
(4) The Portuguese who have ordinarily resided in Macao for a continuous period of not less than seven years and have taken Macao
as their place of permanent residence before or after the establishment of the Macao Special Administrative Region;
(5) Other persons who have ordinarily resided in Macao for a continuous period of not less than seven years and have taken Macao as
their place of permanent residence before or after the establishment of the Macao Special Administrative Region;
(6) Persons under 18 years of age born in Macao of those residents listed in category (5) before or after the establishment of the
Macao Special Administrative Region.
The above mentioned residents shall have the right of abode in the Macao Special Administrative Region and shall be qualified to obtain
permanent identity cards.
The non-permanent residents of the Macao Special Administrative Region shall be persons who are qualified to obtain Macao identity
cards in accordance with the laws of the Region but have no right of abode.
Article 25
All Macao residents shall be equal before the law, and shall be free from discrimination, irrespective of their nationality descent,
race, sex, language, religion, political persuasion or ideological belief, educational level, economic status or social conditions.
Article 26
Permanent residents of the Macao Special Administrative Region shall have the right to vote and the right to stand for election in
accordance with law.
Article 27
Macao residents shall have freedom of speech, of the press and of publication; freedom of association, of assembly, Of procession
and of demonstration; and the right and freedom to form and join trade unions, and to strike.
Article 28
The freedom of the person of Macao residents shall be inviolable.
No Macao resident shall be subjected to arbitrary or unlawful arrest, detention or imprisonment. In case of arbitrary or unlawful
detention or imprisonment, Macao residents have the right to apply to the court for the issuance of a writ of habeas corpus.
Unlawful search of the body of any resident or deprivation or restriction of the freedom of the person shall be prohibited.
Torture or inhuman treatment of any resident shall be prohibited.
Article 29
Macao residents shall not be punished by law, unless their acts constitute a crime and they shall be punished for it as expressly
prescribed by law at the time.
When charged with criminal offences, Macao residents shall enjoy the right to an early court trial and shall be presumed innocent
before convicted.
Article 30
The human dignity of Macao residents shall be inviolable. Humiliation, slander and false accusation against residents in any form
shall be prohibited.
Macao residents shall enjoy the right to personal reputation and the privacy of their private and family life.
Article 31
The homes and other premises of Macao residents shall be inviolable Arbitrary or unlawful search of, or intrusion into, a resident’s
home or other premises shall be prohibited.
Article 32
The freedom and privacy of communication of Macao residents shall be protected by law. No department or individual may, on any grounds,
infringe upon the freedom and privacy of communication of residents except that the relevant authorities may inspect communication
in accordance with the provisions of the law to meet the needs of public security or of investigation into criminal offences.
Article 33
Macao residents shall have freedom of movement within the Macao Special Administrative Region and freedom of emigration to other countries
and regions. They shall have freedom to travel and to enter or leave the Region and shall have the right to obtain travel documents
in accordance with law. Unless restrained by law, holders of valid travel documents shall be free to leave the Region without special
authorization.
Article 34
Macao residents shall have freedom of conscience.
Macao residents shall have freedom of religious belief and freedom to preach and to conduct and participate in religious activities
in public.
Article 35
Macao residents shall have freedom of choice of occupation and work.
Article 36
Macao residents shall have the right to resort to law and to have access to the courts, to lawyers’ help for protection of their lawful
rights and interests, and to judicial remedies.
Macao residents shall have the right to institute legal proceedings in the courts against the acts of the executive authorities and
their personnel.
Article 37
Macao residents shall have freedom to engage in education, academic research, literary and artistic creation, and other cultural activities.
Article 38
The freedom of marriage of Macao residents and their right to form and raise a family freely shall be protected by law.
The legitimate rights and interests of women shall be protected by the Macao Special Administrative Region.
The minors, the aged and the disabled shall be taken care of and protected by the Macao Special Administrative Region.
Article 39
Macao residents shall have the right to social welfare in accordance with law. The welfare benefits and retirement security of the
labour force shall be protected by law.
Article 40
The provisions of International Covenant on Civil and Political Rights, International Covenant on Economic, Social and Cultural Rights,
and international labour conventions as applied to Macao shall remain in force and shall be implemented through the laws of the Macao
Special Administrative Region.
The rights and freedoms enjoyed by Macao residents shall not be restricted unless as prescribed by law. Such restrictions shall not
contravene the provisions of the first paragraph of this Article.
Article 41
Macao residents shall enjoy the other rights and freedoms safeguarded by the laws of the Macao Special Administrative Region.
Article 42
The interests of the residents of Portuguese descent in Macao shall be protected by the Macao Special Administrative Legion in accordance
with law, and their customs and cultural raditions shall be respected.
Article 43
Persons in the Macao Special Administrative Region other than Macao residents shall, in accordance with law, enjoy the rights and
freedoms of Macao residents prescribed in his Chapter.
Article 44
Macao residents and other persons in Macao shall have the obligation to abide by the laws in force in the Macao Special Administrative
Region.
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Chapter IV
Political Structure
Section 1 The Chief Executive
Article 45
The Chief Executive of the Macao Special Administrative Region shall be the head of the Macao Special Administrative Region and shall
represent the Region.
The Chief Executive of the Macao Special Administrative Region shall be accountable to the Central People’s Government and the Macao
Special Administrative Region in accordance with the provisions of this Law.
Article 46
The Chief Executive of the Macao Special Administrative Region shall be a Chinese citizen of not less than 40 years of age who is
a permanent resident of the Region and has ordinarily resided in Macao for a continuous period of not less than 20 years.
Article 47
The Chief Executive of the Macao Special Administrative Region shall be selected by election or through consultations held locally
and be appointed by the Central People’s Government.
The specific method for selecting the Chief Executive is prescribed in Annex I: “Method for the Selection of the Chief Executive of
the Macao Special Administrative Region”.
Article 48
The term of office of the Chief Executive of the Macao Special Administrative Region shall be five years. He or she may serve for
not more than two consecutive terms.
Article 49
The Chief Executive of the Macao Special Administrative Region, during his or her term of office, shall have no right of abode in
any foreign country and shall not engage in any activities for his or her personal gains. The Chief Executive, on assuming office,
shall declare his or her assets No the President of the Court of Final Appeal of the Macac Special Administrative Region. This declaration
shall be put on record.
Article 50
The Chief Executive of the Macao Special Administrative Region shall exercise the following powers and functions:
(1) To lead the government of the Region;
(2) To be responsible for the implementation of this Law and other laws which, in accordance with this Law, apply in the Macao Special
Administrative Region;
(3) To sign bills passed by the Legislative Council and to promulgate laws;
To sign budgets passed by the Legislative Council and report the budgets and final accounts to the Central People s Government for
the record;
(4) To decide on government policies and to issue executive orders;
(5) To formulate the administrative regulations and promulgate them for implementation;
(6) To nominate and to report to the Central People’s Government for appointment the following principal officials: Secretaries of
Departments, Commissioner against Corruptions Director of Audit, the leading members of the Police and the customs and excise; and
to recommend to the Central People s Government the removal of the above mentioned officials;
(7) To appoint part of the members of the Legislative Council;
(8) To appoint or r^emove members of the Executive Council;
(9) To appoint or remove presidents and judges of the courts at all levels and procurators in accordance with legal procedures;
(10) To nominate and report to the Central People’s Government for appointment of the Procurator-General and recommend to the Central
People’s Government the removal of the Procurator-General in accordance with legal procedures;
(11) To appoint or remove holders of public office in accordance with legal procedures;
(12) To implement the directives issued by the Central People’s Government in respect of the relevant matters provided for in this
Law;
(13) To conduct, on behalf of the Government’ of the Macao Special Administrative Region, external affairs and Other affairs as authorized
by the Central Authorities;
(14) To approve the introduction of motions regarding revenues or expenditure to the Legislative Council;
(15) To decide, in the light of security and vital interests, whether government officials or other personnel in charge of government
affairs should testify or give evidence before the Legislative Council or its committees;
(16) To confer medals and post_titles of honour of the Macao Special Administrative Region in accordance with law;
(17) To pardon persons convicted of criminal offences or commute their penalties in accordance with law; and
(18) To handle petitions and complaints.
Article 51
If the Chief Executive of the Macao Special Administrative Region considers that a bill passed by the Legislative Council is not compatible
with the overall interests of the Region, he or she may give his or her reasons in writing and return it to the Legislative Council
within 90 days for reconsideration. If the Legislative Council passes the original bill again by not less than a two-thirds majority
of all the members, the Chief Executive must sign and promulgate it within 30 days or act in accordance with the provisions of Article
52 of this Law.
Article 52
The Chief Executive of the Macao Special Administrative Region may dissolve the Legislative Council under any of the following circumstances:
(1) The Chief Executive refuses to sign a bill passed the second time by the Legislative Council; and
(2) The Legislative Council refuses to pass a budget introduced by the government or any other bills which he or she considers concern
the overall interests of the Region, and after consultations, consensus still cannot be reached.
Before dissolving the Legislative Council, the Chief Executive must consult the Executive Council and he or she shall explain the
reason for it to the public.
The Chief Executive may dissolve the Legislative Council only once in each term of his or her office.
Article 53
If the Legislative Council of the Macao Special Administrative Region fails to pass the budget introduced by the government, the Chief
Executive may approve provisional short-term appropriations according to the level of expenditure of the previous fiscal year.
Article 54
The Chief Executive of the Macao Special Administrative Region must resign under any of the following circumstances:
(1) When he or she loses the ability to discharge his or her duties as a result of serious illness or other reasons;
(2) When, after the Legislative Council is dissolved because he or she twice refuses to sign a bill passed by it, the new Legislative
Council again passes by a two-thirds majority of all the members the original bill in dispute, but he or she still refuses to sign
it within 30 days; and
(3) When, after the Legislative Council is dissolved because it refuses to pass a budget or any other bill concerning the overall
interests of the Macao Special Administrative Region, the newly elected Legislative Council still refuses to pass the original bill
in dispute.
Article 55
If the Chief Executive of the Macao Special Administrative Region is not able to discharge his or her duties for a short period, such
duties shall temporarily be assumed by the secretaries of the departments in the order of precedence, which shall be stipulated by
law.
In the event that the office of Chief Executive becomes vacant, a new Chief Execut
Regulations on Administrative Protection of Pharmaceuticals
Chapter I General Provisions Chapter II Application for Administrative Protection Chapter III Examination and Approval of Administrative
Protection Chapter IV Duration, Cessation, Revocation and Effect of Administrative Protection Chapter V Supplementary Provisions
Article 1 These Regulations are formulated with a view to expanding economic and technological cooperation and exchange with
foreign countries and providing administrative protection for the lawful rights and interests of the owners of the exclusive
right of foreign pharmaceuticals.
Article 2 The pharmaceuticals as mentioned in these Regulations refer to medicines for human beings.
Article 3 Enterprises and other organizations or individuals from any country or region which has concluded bilateral treaty or agreement
with the People’s Republic of China on administrative protection of pharmaceuticals may apply for administrative
protection of pharmaceuticals in accordance with these Regulations.
Article 4 The competent administrative department for the production and distribution of pharmaceuticals under the State Council shall accept
and examine applications for administrative protection of pharmaceuticals, grant administrative protection to the pharmaceuticals
which conform with the provisions of these Regulations, and issue to the applicants the certificates for administrative
protection.
CHAPTER II APPLICATION FOR ADMINISTRATIVE PROTECTION
Article 5 A pharmaceutical to be applied for administrative protection shall meet the following requirements:
(1) Its exclusive right was not subject to protection in accordance with the provisions of the China’s Patent Law prior to January,
1, 1993;
(2) Its exclusive right to prohibit others from making, using or selling it in the country to which the applicant belongs was
granted after January 1, 1986 and before January 1, 1993;
(3) It has not been marketed in China prior to the date of filing the application for administrative protection.
Article 6 The right of applying for administrative protection of a pharmaceutical belongs to the owner of the exclusive right
of the pharmaceutical.
Article 7 Where an owner of the exclusive right of a foreign pharmaceutical applies for administrative protection, he shall
appoint an agency designated by the competent administrative department for the production and distribution of pharmaceuticals
under the State Council to undertake the matter.
Article 8 An applicant shall submit the Chinese and foreign language bilingual versions of following documents:
(1) an application for administrative protection of the pharmaceutical;
(2) a copy of the certificate issued by the competent authorities of the country to which the applicant belongs granting such exclusive
right;
(3) a copy of the document issued by the competent authorities of the country to which the application belongs approving the
manufacture or marketing of the pharmaceutical;
(4) a copy of the contract for the manufacture or marketing of the pharmaceutical in China formally entered into between the
applicant and a Chinese enterprise as legal person (including foreign capital enterprises, Chinese-foreign joint ventures,
or Chinese-foreign equity contractual joint ventures) which has been permitted to manufacture or market pharmaceuticals in
accordance with the relevant Chinese laws and regulations.
Article 9 Before or after applying for the administrative protection, the owner of the exclusive right of a foreign pharmaceutical shall
apply to the administrative department of health under the State Council for going through the procedures for permitting the
manufacture or marketing of the pharmaceutical in China, in accordance with the provisions of the Pharmaceutical Administration
Law of the People’s Republic of China.
CHAPTER III EXAMINATION AND APPROVAL OF ADMINISTRATIVE PROTECTION
Article 10 Within 15 days from the date of receipt of the application documents for administrative protection, the competent administrative
department for the production and distribution of pharmaceuticals under the State Council, upon preliminary examination, shall
handle the case in either of following measures according to different conditions:
(1) Where the application documents are in conformity with the provisions of Article 8 of these Regulations, issue
the notice of acceptance and announce it;
(2) Where the application documents are not in conformity with the provisions of Article 8 of these Regulations, require
the applicant to complete them within a definite time limit; if on the expiry of the time limit the requirement is not met,
the application shall be deemed as not having been filed.
Article 11 The competent administrative department for the production and distribution of pharmaceuticals under the State Council shall
finish the examination within six months from the date of receipt of the application documents, or from the date of receipt
of the complementary documents stipulated in Article 10, Item (2) of these Regulations. If, under special circumstances,
the examination cannot be finished within six months, the competent administrative department for the production and distribution
of pharmaceuticals under the State Council shall promptly notify the applicant, give the reason and properly prolong the
examination time.
After examination, where the application is in conformity with the provisions of these Regulations, the administrative protection
shall be granted; where the application is not in conformity with the provisions of these Regulations, no administrative protection
shall be granted and the reasons shall be given.
Article 12 Where a pharmaceutical is granted with administrative protection, the competent administrative department for the production
and distribution of pharmaceuticals under the State Council shall issue the certificate of administrative protection and make
an announcement.
CHAPTER IV DURATION, CESSATION, REVOCATION AND EFFECT OF ADMINISTRATIVE PROTECTION
Article 13 The duration of administrative protection of a pharmaceutical is seven years and six months beginning from the date on which
the certificate of administrative protection is issued.
Article 14 The owner of the exclusive right of a foreign pharmaceutical shall pay an annual fee beginning with the year in which the certificate
of administrative protection of the pharmaceutical is issued.
Article 15 In any of the following cases, the administrative protection shall cease before the expiration of its duration:
(1) where the exclusive right of a pharmaceutical is ineffective or becomes invalid in the country to which the applicant belongs;
(2) where the owner of the exclusive right of a pharmaceutical does not pay the annual fee as prescribed;
(3) where the owner of the exclusive right of a pharmaceutical waives the administrative protection by a written declaration;
(4) where the owner of the exclusive right of a pharmaceutical does not apply to the administrative department of health under
the State Council for going through the procedures for permitting the manufacture or marketing of this pharmaceutical in
China within a year from the date on which the certificate of administrative protection of the pharmaceutical is issued.
Article 16 After the certificate for administrative protection of a pharmaceutical has been issued, any organization or individual
that thinks that the grant of administrative protection to the pharmaceutical is not in conformity with the provisions of
these Regulations may request the competent administrative department for the production and distribution of pharmaceuticals
under the State Council to revoke the administrative protection of the pharmaceutical. Where the owner of the exclusive right
of the pharmaceutical is not satisfied with the revocation decision made by the competent administrative department for
the production and distribution of pharmaceuticals under the State Council, may institute legal proceedings in a people’s
court.
Article 17 The cessation or revocation of the administrative protection of a pharmaceutical shall be announced by the competent administrative
department for the production and distribution of pharmaceuticals under the State Council.
Article 18 For the pharmaceuticals which have obtained administrative protection, without the authorization of the owners of the exclusive
right of the pharmaceuticals, the administrative department of health under the State Council or the administrative departments
of health of provinces, autonomous regions or municipalities directly under the Central Government may not permit others
to manufacture or sell them.
Article 19 Where there is any manufacture or marketing of a pharmaceutical without authorization of the owner of the exclusive
right of the pharmaceutical who has obtained administrative protection, the owner of the exclusive right of the pharmaceutical
may request the competent administrative department for the production and distribution of pharmaceuticals under the State
Council to check the infringing act; if the owner of the exclusive right of the pharmaceutical claims for economic compensation,
he may institute a legal proceedings in a people’s court.
CHAPTER V SUPPLEMENTARY PROVISIONS
Article 20 The competent administrative department for the production and distribution of pharmaceuticals under the State Council shall
take measures to keep secret all the materials provided by applicants which require to be kept secret.
Article 21 Fees shall be paid as prescribed for filing the application for administrative protection of pharmaceuticals and fulfilling
any other relevant procedures with the competent administrative department for the production and distribution of pharmaceuticals
under the State Council.
Article 22 The rules for the implementation of these Regulations shall be formulated by the competent administrative department for
the production and distribution of pharmaceuticals under the State Council.
Article 23 The competent administrative department for the production and distribution of pharmaceuticals under the State Council
shall be responsible for the interpretation of these Regulations.
Article 24 These Regulations shall enter into force as of January 1, 1993.
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MOFTEC P.R.C.
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EDITOR:Victor
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