Regulations on Administration of Veterinary Drugs
Regulations on Administration of Veterinary Drugs
Regulations on Administration of Veterinary Drugs
Order of the State Council of the People's Republic of China [2001] 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
Appendix: Regulations on Administration of Veterinary Drugs
Released by the State Council on May 21, 1987
Amended in accordance with the Decision of the State Council on the Revision of the Administrative Regulations on Veterinary Drugs
Chapter I General Provisions
Article 1 These Regulations are formulated to strengthen the supervision over and administration of veterinary drugs, ensure the quality of veterinary drugs, effectively prevent and control the diseases of domestic animals, poultry and other animals, so as to promote the development of animal husbandry and safeguard human health.
Article 2 Quality, safety and efficacy shall be ensured in the production, marketing and use of veterinary drugs.
Article 3 The administrative department for animal husbandry and veterinary work of the State Council shall take charge of the administration of veterinary drugs throughout the country, and the administrative departments for animal husbandry and veterinary work of local people's governments at or above the county level shall take charge of the administration of veterinary drugs within the regions under their jurisdiction.
Article 4 Anyone engaged in the production, marketing or use of veterinary drugs shall comply with the provisions of these Regulations.
Chapter II Administration of Veterinary Drug Producing Enterprises
Article 5 A veterinary drug producing enterprise shall meet the following requirements:
1. being staffed with technical personnel with a technical title equivalent to or higher than engineer or veterinarian and skilled workers commensurate with the veterinary drugs to be produced;
2. having premises, facilities and a hygienic environment commensurate with the veterinary drugs to be produced;
3. having facilities and conditions in conformity with the Standards of the State for labour safety and hygiene;
4. having quality inspection institutions, full-time inspection staff, and necessary apparatus and equipments;
5. if an enterprise not specially for producing veterinary drugs concurrently engages in the production of veterinary drugs, it must have separated areas for such production.
Article 6 The establishment of a veterinary drug producing enterprise shall be subject to the examination and consent of the administrative department for animal husbandry and veterinary work of the people's government at the county level in the place where it will be located, then upon the examination and approval of the administrative department for animal husbandry and veterinary work of the people's governments of the province, autonomous region and municipality directly under the Central Government, a Veterinary drug Producing License shall be granted. On the basis of this License, the veterinary drug producing enterprise shall apply to the local administrative department for industry and commerce for registration and, upon approval, be issued a Business License.
Each Veterinary drug Producing License shall have a term of validity. After the expiry of the term, the License may be renewed, upon reexamination, for those up to standards.
Article 7 A veterinary drug producing enterprise shall conduct its production in accordance with the technological procedures, and the data of production shall be recorded completely and accurately. The needed raw and supplementary materials and the containers and package materials in direct contact with veterinary drugs shall meet the requirements for medical use.
Article 8 The package of veterinary drugs shall be labeled, inscribing the words "For Animals" and the directions for use attached. The label or directions for use of a veterinary drug shall inscribe the trade mark, name of the veterinary drug, specification, name of the producing enterprise, the lot number, the serial number of the approval document, as well as the principal ingredients, contents, indications, action, usage, dosage, period of efficacy and precautions, etc.
Article 9 The repackaging of veterinary drugs shall be recorded completely and accurately. The name of the repacked veterinary drug, specification, name of the producing enterprise, the lot number, the serial number of the approval document, name of the repackaging unit and the lot number of the repackaging shall be inscribed on the package and the directions for use shall be attached. If the veterinary drug has a period of efficacy, it shall be inscribed on the new package.
Article 10 A veterinary drug shall be subject to quality inspection before it is dispatched from the factory; those not up to quality standards shall not be dispatched.
A veterinary drug shall bear a qualify inspection certificate when it is dispatched from the factory. A veterinary drug marketing enterprise shall not market drugs without such certificates.
Chapter III Administration of Veterinary Drug Marketing Enterprises
Article 11 A veterinary drug marketing enterprise shall meet the following requirements:
1. having veterinary drug technicians commensurate with the veterinary drugs to be marketed;
2. having premises, equipment and storage facilities commensurate with the veterinary drugs to be marketed.
Article 12 The establishment of a veterinary drug marketing enterprise shall be subject to the approval of the administrative department for animal husbandry and veterinary work of the local people's government at or above the county level and a Veterinary Drug Marketing License shall be issued upon approval.
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