Rules for Implementation of the Regulations on Administrative Protection of Pharmaceuticals

(Promulgated by the State Pharmaceutical Administration of the People's Republic of China on December 30, 1992)
Chapter I General Provisions

Article 1 These Rules are formulated in accordance with the provisions 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 distribution 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 examination 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, refer to substances intended for use in the prevention, treatment or diagnosis of human diseases, or intended to effect the purposive regulation 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 administrative 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 Regulations 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 official holiday, the time limit shall expire on the first working day after that official holiday.

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 applicant belongs.

Article 11　Where an applicant entrusts the agency to attend to application for administrative protection, both parties shall sign a power of attorney, 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 Regulations 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 enterprise 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 administrative protection, an applicant requires to withdraw his or its application for administrative protection, he or it shall submit a written declaration 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.

Chapter III Examination and Approval of Application for Administrative Protection

Article 16　Where documents submitted to the Office for Administrative 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 examination time stipulated in Article 11 of the Regulations.

Chapter IV Duration, Cessation, Revocation and Effect of Administrative Protection

Article 18 　The date on which the certificate for administrative protection 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 Pharmaceuticals in which matters relating to any application and approval shall be recorded.

Article 21 The reasons under which a pharmaceutical, granted with administrative protection, may be revoked under Article 16 of the Regulations, 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 Protection 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 examination 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 relevant 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.

Chapter V The Fees

Article 24 　The fees which shall be paid when an application for administrative 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 administrative 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 administrative protection shall be deemed to be given up by the owner automatically.

Article 27 Where anyone requests the Office for Administrative Protection 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 settlement of infringement is submitted.

Article 29 Various fees prescribed, as Article 24 of these Rules shall be charged by the agency.

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 People's Republic of China. In case of discrepancy, the original version in Chinese shall prevail.)