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Regulations on Administrative Protection of Pharmaceuticals (1992)

( Approved by the State Council on December 12, 1992 and
promulgated by the State Pharmaceutical Administration on December 19, 1992 )

Duration, Cessation, Revocation and Effect of Administrative Protectiont

Article 13.   The term of administrative protection begins from the date on which the certificate for administrative protection of a pharmaceutical is issued and remains in force for seven years and six months.

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 for administrative protection of the pharmaceutical is is-sued.

Article 15.   In any of the following cases, administrative protection shall cease before the expiration of its duration:

(1) where the exclusive right of a pharmaceutical had been invalid or had lost efficacy in the country to which the applicant belongs;

(2) where the owner of the exclusive right of a pharmaceutical does not pay an annual fee as prescribed;

(3) where the owner of the exclusive right of a pharmaceutical aban-dons 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 of approval for manufacture or marketing of this pharmaceutical in China within a year from the date on which the certificate for administrative protection of the pharmaceutical is issued.

Article 16.   Where, after the certificate for administrative protection of a pharmaceutical has been issued, any organization or individual thinks that the grant of administrative protection to the subject pharmaceutical is not in conformity with the provisions of these Regula-tions, it or he may request the competent authorities for the production and distribution of pharmaceuticals under the State Council to revoke the administrative protection of the subject pharmaceutical. Where the owner of the exclusive right of the pharmaceutical is not satisfied with the revo-cation decision made by the competent authorities for the production and distribution of pharmaceuticals under the State Council, it or he may in-stitute legal proceedings in the people's court.

Article 17.   The cessation or revocation of administrative protection of pharmaceuticals shall be announced by the competent authorities for the production and distribution of pharmaceuticals under the State Council.

Article 18.   For the pharmaceuticals which have obtained administra-tive protection, without the authorization of the owners of the exclusive right of the pharmaceuticals, the administrative department of health un-der the State Council and the administrative departments of health of provinces, autonomous regions or municipalities directly under the Cen-tral Government shall not ratify 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 com-petent authorities for the production and distribution of pharmaceuticals under the State Council to stop the infringing act; if the owner of the ex-clusive right of the pharmaceutical requests for economic compensation, he or it may institute legal proceedings in the people's court.