Administrative Measures for the Approval Numbers of Veterinary Drug Products
Administrative Measures for the Approval Numbers of Veterinary Drug Products
Administrative Measures for the Approval Numbers of Veterinary Drug Products
Order of the Ministry of Agriculture [2004] No. 45
November 24, 2004
The Administrative Measures for the Approval Numbers of Veterinary Drug Products, which were deliberated and adopted at the executive meeting of the Ministry of Agriculture on November 15, 2004, are hereby promulgated.
Minister Du Qinglin
Attached: Administrative Measures for the Approval Numbers of Veterinary Drug Products
Chapter I General Provisions
Article 1 These Measures are formulated in accordance with the Regulations on Veterinary Drug Administration for the purpose of strengthening the administration on the approval numbers of veterinary drug products.
Article 2 These Measures shall apply to the application for, issue of and supervision over the approval numbers of veterinary drug products.
Article 3 Veterinary drug production enterprises shall obtain the product approval number as is issued by the Ministry of Agriculture for the production of veterinary drugs.
The approval numbers of veterinary drug products is the certificate document of approval for veterinary drugs, which is issued by the Ministry of Agriculture on the basis of the national standards for veterinary drugs, production techniques, and production conditions when approving any special veterinary drug production enterprise to produce any special veterinary drug product.
Article 4 The Ministry of Agriculture shall be responsible for the work of issuing and supervising the approval numbers of veterinary drug products of the whole country.
The veterinary administrative departments of the local people's governments at or above the county level shall be responsible for the supervision over and administration of approval numbers of veterinary drug products within their respective administrative regions.
Chapter II Application for and Issue of Approval Numbers of Veterinary Drug Products
Article 5 When applying for the approval numbers of any veterinary drug product, for which the national standards on veterinary drugs except the biological products have been promulgated, an applicant shall submit the samples in three consecutive batches produced by itself and the following materials to the veterinary administrative department of the local people's government at the provincial level:
1. The Application Form for Approval Numbers of Veterinary Drug Products in duplicate;
2. The copies, in duplicate, of the License for Veterinary Drug Production;
3. The copies, in duplicate, of the GMP Certificate of Veterinary Drugs;
4. The stylebook, in duplicate, of labels and the instruction book; and
5. The self-inspection report, in duplicate, on the samples submitted.
The veterinary administrative department of the people's government at the provincial level shall, within five working days from the date of acceptance of the application, send the samples to a veterinary drug inspection institution for inspection, and shall complete the examination within 15 working days from the date of acceptance of the inspection conclusions, and send a copy of the examination opinions, the inspection report issued by the inspection institution, and all the application documents to the Ministry of Agriculture.
The Ministry of Agriculture shall complete the examination within 20 working days from the date when it receives the examination opinions of the veterinary administrative department of the people's government at the provincial level. If the veterinary drug product passes the examination, the Ministry of Agriculture shall issue the approval number of this product and publicize the labels and the instruction book.
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