Decision of the State Council on the Revision of the Administrative Regulations on Veterinary Drugs

Decision of the State Council on the Revision of the Administrative Regulations on Veterinary Drugs

Order of the State Council of the People's Republic of China No. 325

November 29, 2001

The Decision of the State Council on the Revision of the Administrative Regulations on Veterinary Drugs is released hereby and shall take effect as of the date of promulgation.

Premier Zhu Rongji

Decision of the State Council on the Revision of the Administrative Regulations on Veterinary Drugs

The State Council decides to make the following amendments to the Regulations on Administration of Veterinary Drugs:
　
Article 1 One article is added as Article 27: "The State offers protection to undisclosed test or other data acquired and submitted by the applicant of a veterinary drug that has been approved or registered according to law and contains new chemical entities.
"For a period of six years from the date of approval or registration, if any second applicant applies for approval or registration of a veterinary drug by relying on the data provided in the preceding paragraph without the permission of the applicant who has been granted approval or registration, the approval or registration department shall grant no approval or registration, unless the second applicant has submitted his own data."
"Except for the following circumstances, the approval or registration department shall not disclose the data provided in the first paragraph:
1. the disclosure of such data is necessary to protect the public;
2. steps have been taken to ensure that the data are protected against unfair commercial use."
　
Article 2 One article is added as Article 37: "Any unit or individual using veterinary drugs shall comply with the provisions on safe use formulated by the administrative department for animal husbandry and veterinary work of the State Council.
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