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"Regulations on the Administrative Protection of Drugs"
Release time: 2018-12-24 & nbsp & nbsp & nbsp Source: Anonymous



Chapter 1 General Principles
Chapter 2 Application for Administrative Protection
stake betting appChapter 3 Examination and approval of administrative protection
Chapter 4 The term of administrative protection、Termination、Revisibility and effectiveness
Chapter 5 Attachment


Chapter 1 General Principles

Article 1 In order to expand foreign economic and technological cooperation and exchange,Gives administrative protection to the legitimate rights and interests of the exclusive rights of foreign medicines,Develop this Regulations。

Pharmaceuticals referred to in these Regulations,refers to the medicine for people。

Article 3 All countries that conclude a bilateral treaty or agreement with the People's Republic of China、Enterprises and other organizations and individuals in the region,You can apply for drug administrative protection in accordance with these regulations。

Article 4 Application for accepting and reviewing the administrative protection of drugs for drug production and operation of the State Council,Give administrative protection to medicines that comply My stake betting appstake online sports bettingwith these regulations,A certificate of drug administrative protection for the applicant is issued。


Chapter 2 Application for Administrative Protection

5 Drugs applying for administrative protection shall have the following conditions:
(1) Before January 1, 1993, in accordance with the provisions of the Chinese Patent Law, its exclusive rights are not protected;
(2) From January 1, 1986 to January 1, 1993,Obtaining prohibited others from manufacturing in the country where the applicant is located、exclusive right to use or sell;
(3) The application for administrative protection has not been sold in China.。

6 The right to apply for administrative protection of drugs belongs to the drug exclusive owner of the drug。

7 Foreign drug exclusively applied for administrative protection,It should be entrusted to the agency designated by the administrative department My stake betting appof drug production and operation of the State Council to handle。

Article 8 The applicant shall submit the Chinese in the following documents、Foreign languages ​​comparison:
(1) Application for administrative protection of drugs;
(2) Certificate issued by the state -related authorities where the applicant is located;
(3) Document copy issued by the state -relevant authorities where the applicant is located;
(4) Applicants and relevant laws in accordance with China、Chinese corporate legal person (including foreign -funded enterprises obtained by regulatory or sales permits、Sino -foreign joint venture business enterprises and Chinese and foreign cooperative business enterprises) officially signed by a contract copy or sold the drug in China。

Article 9 Foreign drug exclusive persons before or after applying for drug administrative protection,The provisions of the Drug Administration Law of the People's Republic of China shall,Applying to the health administrative department of the State Council to handle the procedures for the drug stake betting appto make or sell in China。


stake betting appChapter 3 Examination and approval of administrative protection

Article 10,Preliminary review,and make the following processing separately:
(1) The application file meets the provisions of Article 8 of these Regulations,Send to the acceptance notice,An announcement;
(2) Application documents do not comply with Article 8 of these Regulations,Requires the applicant to make corrections within a time limit;,It is deemed to have not applied。

Article 11 The administrative department My stake betting appof drug production and operation of the State Council shall be from the date of receiving the application document,Or in accordance with the provisions of Article 10 (2) of these regulations,From the date of receiving a correction document,After reviewing within 6 months。It is not possible to review it within 6 months when the situation of the case,The administrative department of drug production and operation of the State Council shall promptly notify the applicant,Reasons for and told,Appropriate extension of review time。
After review,Comply with the provisions of these regulations,Give administrative protection; not comply with the provisions of these regulations,No administrative protection,Reasons for and told。

Article 12 The administrative department of the State Council's Drug Production and Management Administrative Department approves to give drug administrative protection,Issuing a drug administrative protection certificate,Announcement。


Chapter 4 The term of administrative protection、Termination、Revisibility and effectiveness

Article 13 The administrative protection period of the drug is 7 years and 6 months,Calculation from the date of issuance of the administrative protection certificate of the drug。

Article 14 Foreign drug owners shall be issued from the year of the year of the drug administrative protection certificate,Start paying annual fee。

Article 15 There is one of the following situations,Administrative protection ended before the expiration of the term:
(1) Drug exclusive My stake betting apprights are invalid or invalidated by the applicant's country;
(2) Drug exclusive owners who have not paid the annual annual fee of administrative protection in accordance with regulations;
(3) The drug owner of the drug to abandon administrative protection in writing;
(4) Drugs exclusively owner's self -drug administrative protection certificate will not apply to the State Council's health administrative department within one year from the date of the issuance of the drug administrative protection certificate.。

Article 16 After the drug administrative protection certificate is issued,Any organization or individual thinks that the administrative protection of the drug does not comply with the provisions of these regulations,You can request the administrative protection of the administrative department My stake betting appof drug production and operation of the State Council to revoke the administrative protection of the drug;,You can file a lawsuit with the people's court。

Article 17 The termination or withdrawal of the administrative protection of drugs,Announcement by the administrative department My stake betting appof drug production and operation of the State Council。

Article 18 For the medicine that obtained administrative protection,Licensing of the owner of the exclusive owner of the drug,The health administrative department of the State Council and the province、Autonomous Region、The health administrative department of municipality directly under the Central Government shall not approve the manufacturing or sales of others。

Article 19 The permission of the exclusive owner who has not been obtained by the drug administrative protection,Manufacturing or sales of the drug,Drug exclusive owners can request the State Council's drug production and operation administrative department to stop the infringing behavior;,You can file a lawsuit with the people's court。


Chapter 5 Attachment

Article 20,Key measures should be taken。

Article 21 Applying to the administrative department of the State Council for the administrative department My stake betting appof drug production and operation of the State Council,The payment fee shall be paid in accordance with regulations。

Article 22 The implementation rules of these regulations shall be formulated by the administrative department of the State Council's Drug Production and Management。

Article 23 These regulations stake sports betting appshall be explained by the administrative department My stake betting appof drug production and operation of the State Council。

Twenty -four these regulations shall be implemented from January 1, 1993。