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 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 Article 4 The competent administrative department for the production and distribution of pharmaceuticals under the State Council shall accept 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, (2) Its exclusive right to prohibit others from making, using or selling it in the country to which the applicant belongs was (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 Article 7 Where an owner of the exclusive right of a foreign pharmaceutical applies for administrative protection, he shall 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 (3) a copy of the document issued by the competent authorities of the country to which the application belongs approving the (4) a copy of the contract for the manufacture or marketing of the pharmaceutical in China formally entered into between the Article 9 Before or after applying for the administrative protection, the owner of the exclusive right of a foreign pharmaceutical shall 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 (1) Where the application documents are in conformity with the provisions of Article 8 of these Regulations, issue (2) Where the application documents are not in conformity with the provisions of Article 8 of these Regulations, require Article 11 The competent administrative department for the production and distribution of pharmaceuticals under the State Council shall After examination, where the application is in conformity with the provisions of these Regulations, the administrative protection Article 12 Where a pharmaceutical is granted with administrative protection, the competent administrative department for the production
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 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 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 Article 16 After the certificate for administrative protection of a pharmaceutical has been issued, any organization or individual Article 17 The cessation or revocation of the administrative protection of a pharmaceutical shall be announced by the competent administrative Article 18 For the pharmaceuticals which have obtained administrative protection, without the authorization of the owners of the exclusive Article 19 Where there is any manufacture or marketing of a pharmaceutical without authorization of the owner of the exclusive CHAPTER V SUPPLEMENTARY PROVISIONS Article 20 The competent administrative department for the production and distribution of pharmaceuticals under the State Council shall Article 21 Fees shall be paid as prescribed for filing the application for administrative protection of pharmaceuticals and fulfilling Article 22 The rules for the implementation of these Regulations shall be formulated by the competent administrative department for Article 23 The competent administrative department for the production and distribution of pharmaceuticals under the State Council Article 24 These Regulations shall enter into force as of January 1, 1993.
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MOFTEC P.R.C. |
EDITOR:Victor |