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Position：Home > Others > Rules for Implementation of the Regulations on Administrative Protection of Pharmaceuticals (1992) |
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| Rules for Implementation of the Regulations on Administrative Protection of Pharmaceuticals (1992) |
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Promulgated by the State Pharmaceutical Administration of
the People's Republic of China on December 30, 1992 )
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Chapter
I General Provisions
Article
1. These
Rules are formulated in accordance with the provi-sions of Article
22 of the Regulations on Administrative Protection of Pharmaceuticals
(hereinafter referred to as the Regulations).
Article
2. The
competent authorities for the production and distribu-tion of pharmaceuticals
under the State Council, as mentioned in the Regulations, refers to
the State Pharmaceutical Administration of the People's Republic of
China (hereinafter referred to as the SPAC).
The SPAC shall establish the Office for Administrative Protection
of Pharmaceuticals, which shall be in charge of the receiving and
examina-tion of the applications for administrative protection of
pharmaceuticals, the issuance of certificates, the registration and
announcement of relevant matters of administrative protection and
the settlement of infringement disputes.
The administrative department of health under the State Council, as
mentioned in the Regulations, refers to the Ministry of Public Health
of the People's Republic of China.
Article
3. The
pharmaceuticals, as mentioned in the Regulations, re-fer to substances
intended for use in the prevention, treatment or diagnosis of human
diseases, or intended to effect the purposive regula-tion of human
physiological functions, for which indications, usage and dosage are
prescribed.
Article
4. An
owner of the exclusive right of a pharmaceutical, as mentioned in
the Regulations, refers to the person or legal entity that possesses
the complete rights of manufacturing and using and selling of the
pharmaceutical applied for administrative protection.
Article
5. "Has
not been marketed in China", as mentioned in Article 5 (3) of the
Regulations, refers to the pharmaceutical applied for admini-strative
protection had not been distributed through lawful commercial channels
in the pharmaceutical markets within China's territory.
Article
6. The
agency, as mentioned in Article 7 of the Regulations, refers to Huake
Pharmaceutical Intellectual Property Consultative Center.
Article
7. Any
application for administrative protection of pharmaceuticals filed
with the Office for Administrative Protection of Pharmaceuticals and
any other relevant proceedings shall be prepared in the form prescribed
by the SPAC.
Article
8. Where
the documents concerning administrative protection of the Office for
Administrative Protection of Pharmaceuticals need to be sent to an
applicant, they shall be transmitted by the agency.
Article
9. The
first day of any time limit prescribed in the Regula-tions or these
Rules shall not be counted. Where a time limit is counted by year
or by month, it shall expire on the corresponding day of the last
month; if there is no corresponding day in that month , the time limit
shall expire in the last day of that month. If a time limit expires
on an of-ficial holiday, the time limit shall expire on the first
working day after that official holiday.
Go Top
Chapter
II Application for Administrative
Protection
Article
10. The
original language, as mentioned in Article 8 of the Regulations,
refers to the official language of the country to which an ap-plicant
belongs.
Article
11. Where
an applicant entrusts the agency to attend to appli-cation for administrative
protection, both parties shall sign a power of at-torney, which
shall indicate the scope of the power entrusted.
The agency shall submit a power of attorney at the same time of
submitting the application documents to the Office for Administrative
Protection of Pharmaceuticals, as prescribed in Article 8 of the
Regula-tions and these Rules.
Article
12. Each
application for administrative protection of pharmaceuticals shall
be limited to a single pharmaceutical.
Article
13. An
application for administrative protection stipulated in Article
8 (1) of the Regulations shall indicate clearly the following matters:
(1) the name and the address of the applicant;
(2) the nationality of the applicant;
(3) where the applicant is an enterprise or other organization,
the name of the country or the region in which the headquarter of
such en-terprise or organization is located;
(4) the name chemical structure or formulation in case of pharmaceutical
preparation, dosage form, indications, directions for ad-ministration,
dose and a brief introduction to the processing technology of the
pharmaceutical;
(5) the signatures or the seals of the applicant and the agency;
(6) a list of the documents constituting the application;
(7) other relevant matters needing to be indicated.
Article
14. The
various documents submitted by the applicant shall be neat and clear,
and no alteration is allowed. The words of documents shall be written
from left to right. Drawings shall be made with the aid of drafting
instrument.
The standard scientific and technical terms in connection with the
application documents as prescribed by the State shall be used.
Article
15. Where,
prior to the issuance of the certificate for admini-strative protection,
an applicant requires to withdraw his or its applica-tion for administrative
protection, he or it shall submit a written declara-tion to the
Office for Administrative Protection of Pharmaceuticals through
the agency, in which the name of the applicant and the name of the
pharmaceutical shall be indicated.
Go Top
Chapter
III Examination and Approval
of Application for
Administrative Protection
Article
16. Where
documents submitted to the Office for Administra-tive Protection
of Pharmaceuticals belong to any of the following cases, the documents
shall be deemed to have not been submitted:
(1) the documents are not presented in the prescribed form or
the content is not in conformity with the requirements;
(2) the documents have not been submitted as prescribed.
Article
17. The
Office for Administrative Protection of Pharmaceuticals shall
finish the examination promptly, within the exami-nation time
stipulated in Article 11 of the Regulations.
Go Top
Chapter
IV Duration, Cessation,
Revocation and
Effect of Administrative Protectiont
Article
18. The
date on which the certificate for administrative pro-tection
of a pharmaceutical is issued, as mentioned in Article 13 of
the Regulations, refers to the date written on the certificate.
Article
19. The
announcements as stipulated in the Regulations and these Rules,
after being issued by the Office for Administrative Protection
of Pharmaceuticals, shall be published on the China Pharmaceutical
News.
Article
20. The
Office for Administrative Protection of Pharmaceuticals shall
maintain a Register of Administrative Protection of Pharmaceuticls
in which matters relating to any application and ap-proval shall
be recorded.
Article
21. The
reasons under which a pharmaceutical, granted with administrative
protection, may be revoked under Article 16 of the Regu-lations,
refer to the subject pharmaceutical is not in conformity with
the provisions of Article 5 of the Regulations.
Article
22. Anyone
who requests the Office for Administrative Pro-tection of Pharmaceuticals
to revoke administrative protection of a pharmaceutical in accordance
with the provisions of Article 16 of the Regulations, shall
submit a request and state the facts and reasons there-fore
together with the relevant supporting documents, in duplicate.
Article
23. After
the receipt of the request for revocation, the Office for Administrative
Protection of Pharmaceuticals shall make an examina-tion of
it . Where facts and reasons for revocation are not stated in
the request or the reasons for revocation do not conform to
the provisions of Article 21 of these Rules, the request shall
not be accepted by the Office for Administrative Protection
of Pharmaceuticals.
The Office for Administrative Protection of Pharmaceuticals
shall deliver a copy of the accepted request and copies of relevent
testimonial documents to the owner of the exclusive right obtained
administrative protection, and shall require him or it to submit
his or its observation within a specified time limit.
Go Top
Chapter
V The Fees
Article
24. The
fees which shall be paid when an application for ad-ministrative
protection is filed, or when other procedures are gone
through with the Office for Administrative Protection
of Pharmaceuticals, are as follows:
(1) application fee;
(2) examination fee;
(3) annual fee;
(4) announcement fee;
(5) certificate fee;
(6) fee for a request for revocation;
(7) fee for settlement of infringement disputes.
The amount of the fees listed above shall be prescribed
by the SPAC separately.
Article
25. An
applicant shall pay the application fee at the same time
of filing the application for administrative protection;
and shall pay the examination fee and announcement fee
within one month from the date on which the notification
of acceptance is received. Where, without any justified
reason, the fees are not paid or the balance is not made
up within the time limit, the application shall be deemed
to have been withdrawn.
Article
26. The
owner of the exclusive right of a pharmaceutical shall
pay the certificate fee, the announcement fee and the
annual fee for the year within one month from the date
on which the certificate for admini-strative protection
is issued. During the effective term of administrative
protection, the owner shall pay an annual fee for the
year within the first two months of each year. Where ,
without any justified reason, the fees are not paid or
the balance is not made up within the time limit, the
ad-ministrative protection shall be deemed to be given
up by the owner automatically.
Article
27. Where
anyone requests the Office for Administrative Pro-tection
of Pharmaceuticals to revoke administrative protection
of a pharmaceutical in accordance with Article 16 of the
Regulations, he or it shall pay the fee for a request
for revocation at the time the request for revocation
is submitted.
Article
28. Where
the owner of the exclusive right of a pharmaceutical obtained
administrative protection requests the Office for Administrative
Protection of Pharmaceuticals to stop the infringing act
in accordance with Article 19 of the Regulations, the
owner shall pay the fee for settlement of infringement
disputes at the time the request for settle-ment of infringement
is submitted.
Article
29. Various
fees prescribed, as Article 24 of these Rules shall be
charged by the agency.
Go Top
Chapter
VI Supplementary Provisions
Article
30. The
SPAC shall be responsible for the interpretation of these
Rules.
Article
31. These
Rules shall enter into force on January 1, 1993.
(Translated by the State Pharmaceutical Administration
of the Peo-ple's Republic of China. In case of discrepancy,
the original version in Chinese shall prevail)
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