Regulations on Administrative Protection of Pharmaceuticals

(Approved by the State Council on December 12, 1992 and promulgated by Decree No. 12 of the State Pharmaceutical Administration on December 19, 1992)
Chapter I General 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;
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(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;
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(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;
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(2) a copy of the certificate issued by the competent authorities of the country to which the applicant belongs granting such exclusive right;
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(3) a copy of the document issued by the competent authorities of the country to which the applicant belongs approving the manufacture or marketing of the pharmaceutical;
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(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 reason 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 13The 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.