Implementation Measures of Hubei Province on Administration of Veterinary Drugs

· Document Number：Decree No.321 of the People's Government of Hubei Province

· Area of Law： Agriculture Animal Husbandry Fisheries Forestry

· Level of Authority： Local Government Rules

· Date issued：07-15-2008

· Effective Date：09-01-2008

· Status： Effective

· Issuing Authority： Hubei Province

Decree of the People's Government of Hubei Province
(No. 321)
Implementation Measures of Hubei Province on Administration of Veterinary Drugs, deliberated and adopted at the Executive Meeting of the People's Government of Hubei Province on July 7, 2008, are hereby promulgated and shall come into force as of September 1, 2008.
Governor: Li Hongzhong
July 15, 2008
Implementation Measures of Hubei Province on Administration of Veterinary Drugs
Article 1. With an view to enhancing the supervision and administration of veterinary drugs, ensuring the quality of veterinary drugs and the safety and effectiveness of animal medication, controlling the veterinary drug residues in the livestock products, promoting the livestock breeding industry and safeguarding the people's health, these Implementation Measures are formulated in accordance with Regulations on Administration Veterinary Drugs and in light of the actual situation of the Province.
Article 2. These Implementation Measures shall be applicable to those engaged in the production, business operation, utilization, supervision and administration of the veterinary drugs within the administrative area of the Province.
Article 3. The people's government above county level shall enhance the guidance on the supervision and administration of veterinary drugs, consummate the quality monitoring system of veterinary drugs, adopt the veterinary drugs reserve system and bring the outlays for supervision and administration of veterinary drugs into the financial budget at the same level.
Article 4. The administrative department of veterinary drugs in the people's government above county level shall be responsible for the supervision and administration of veterinary drugs within its own administrative area.
Article 5. Where an enterprise for manufacturing veterinary drugs is established, the requirements in Quality Administration Criteria in Production of Veterinary Drugs shall be satisfied and the procedures shall be handled for Manufacturing Permit of Veterinary Drugs
Article 6. The raw materials and supplementary materials employed in the production of veterinary drugs by the enterprise shall satisfy the norms of the State or the quality requirements for production of veterinary drugs.
Whichever of the enterprise engaged in production of veterinary drugs shall obtain the registered number of approval checked and issued by the veterinary administrative department of the State Council. The application and report of the registered number of approval for production of veterinary drugs shall be implemented in accordance with the relevant stipulations of the State.
Article 7. The veterinary drugs manufacturing enterprise shall set up the complete production record and inspection record. All the records shall be retained for one year after the validity of the batch of veterinary drugs expires. If there is no indication of validity, the records shall be retained for three years.
Article 8. Regarding the already registered veterinary drugs, if the originally approved items are necessary to change, it shall be checked by the veterinary administrative department in the provincial people's government and be reported to the veterinary administrative department of the State Council for handling the procedures for alteration registration.
Article 9. The veterinary drugs manufacturing enterprise shall organize the production strictly in accordance with the registered number of approval of the State. It is forbidden to accept the entrustment or consign another enterprise to process veterinary drugs.
Article 10. The enterprise for business operation of veterinary drugs shall be equipped with the qualifications as follows:
(1). professional technicians corresponding to the concerned veterinary drugs;
(2). sites, facilities and storage structures for business operation of the corresponding veterinary drugs;
(3). quality control organ or personnel corresponding to the concerned veterinary drugs.
(4). other business operation conditions stipulated in Quality Control Criteria for Business Operation of Veterinary Drugs.
Where the requirements in the preceding paragraph are satisfied, the applicant may apply to the veterinary administrative department in the city or county people's government with the submission of the documentary materials justifying the satisfaction of the preceding paragraph requirements. Whoever engaged in the business operation of veterinary biological products shall apply to the veterinary administrative department in the provincial people's government with the submission of the documentary materials justifying the satisfaction of the preceding paragraph requirements.
The veterinary administrative department in the people's government above county level shall complete the check within thirty working days as of the date of receiving the application. Where it proves qualified, the business operation permit of veterinary drugs shall be granted; where it proves unqualified, the applicant shall be informed of that in a written form. The applicant shall handle the procedures for industry and commerce registration by means of presenting the business operation permit of veterinary drugs.
Article 11. The enterprise for business operation of veterinary drugs shall observe Quality Control Criteria for Business Operation of Veterinary Drugs formulated by the veterinary administrative department of the State Council.
The veterinary administrative department in the people's government above county level shall conduct the supervision and inspection of the enterprise for business operation of veterinary drugs, checking whether it satisfies Quality Control Criteria for Business Operation of Veterinary Drugs. The inspection consequence shall be published.
Article 12. The enterprise for business operation of veterinary drugs shall purchase veterinary drugs from the enterprises with the legally obtained the veterinary drugs manufacture license and the business operation permit for veterinary drugs. A purchase and sale contract shall be concluded with the inclusion of the quality guarantee clauses.
It is forbidden for any unit or individual without the business operation permit for veterinary drugs to engage in business operation of veterinary drugs in a disguised way under the name of technical service, procurement service, and proxy sale and so on.
It is forbidden for the enterprise to make unauthorized alteration of the business operation site or conduct the business operation of veterinary drugs in another place.
The enterprise for business operation of veterinary drugs shall set up the purchase and sale records in accordance with the stipulations, which shall be retained for three years.
Article 13. Where the large-scale livestock breeding enterprise purchases the nationally immunized veterinary biological products, the data of the purchased veterinary biological products including breed, quantity, and manufacturing enterprise shall all be reported to the local veterinary administrative department for registration.
Article 14. Where the enterprise engages in the business operation of the veterinary narcotics, psychotropic substances and other special veterinary drugs, it shall be controlled in accordance with the relevant stipulations of the State.
The enterprise for business operation of special veterinary drugs shall be designated by the local veterinary administrative department.
Article 15. Any unit or individual engaged in utilization of veterinary drugs shall observe the stipulations on safety use of the veterinary drugs formulated by the veterinary administrative department of State Council, set up the medication records and retain them for registration consultation. The records shall cover the name of the veterinary drugs manufacturing enterprises, the registered number of approval, labels and so on.
It is forbidden to utilize the fake or inferior veterinary drugs or the medicines and other chemical compounds prohibited by the veterinary administrative department of State Council.
Article 16. Where the medication is conducted by means of feedstuff additives, the feedstuff drug additive in the feedstuff products shall satisfy the stipulations of Criteria for Utilization of Feedstuff Drug Additives promulgated by Ministry of Agriculture.
Where there are feedstuff drug additives in the feedstuff, the label of the products shall clearly indicate the containment of the drug additives and list the chemical name of contained drugs, the active ingredients, the percentage, the withdrawal phase, cautions, etc.
Article 17. It is forbidden for butchery enterprise to purchase or butcher the livestock containing the illicit drugs or in the medication phase or in the withdrawal phase.
It is forbidden to distribute the livestock containing the illicit drugs or in the medication phase or in the withdrawal phase and its related products for food purpose.
Article 18. Where the veterinary user unit or individual uses the narcotics, psychotropic substances and other special veterinary drugs, the party concerned shall implement the stipulations on administration of special veterinary drugs of the State, obtain the medication prescription from a licensed veterinarian and retain the prescription for registration and inspection.
Article 19. The veterinary administrative department in the people's government above county level shall exert the power in supervision and administration over veterinary drugs and perform the monitoring inspection over the production, business operation and utilization of veterinary drugs and other procedures.
Whoever inspected shall truthfully provide the related data and samples. It is forbidden to refuse supervision and inspection.
The veterinary administrative department in the people's government above county level shall enhance the cultivation of the legal knowledge and safety awareness of the veterinary drugs manufacturers, dealers, and users.
Article 20. The veterinary drugs administrative department in the provincial people's government shall set up the veterinary drug testing agency, responsible for the quality supervision and inspection over the veterinary drug products and the feedstuff drug additives and checking the veterinary drug residues in the livestock products.
The veterinary drug supervision and inspection consequences and the veterinary drug residue findings shall be published by the veterinary administrative department in the provincial people's government.
Article 21. Where the veterinary administrative department conducts the supervision and inspection according to law, it shall take the administrative coercive measures of sealing up or detaining those possibly fake and inferior veterinary drugs and shall make the official decision on whether to file the case within seven working days as of the day of taking the administrative coercive measures; where it is necessary to make further inspection and check, the official decision on whether to file the case shall be made within ten working days as of the date of sending out the check report; where it does not satisfy the conditions for filing the case, the administrative coercive measures shall be immediately dissolved.
It is forbidden to make unauthorized transfer, utilization, destruction, and distribution of the sealed-up or detained veterinary drugs and the related data without the approval of the organ which makes the administrative coercive measures or its superior organ.
Article 22. Where the enterprise for production or business operation of veterinary drugs makes advertisement on local media, application shall be submitted to the veterinary administrative department in the provincial people's government. The veterinary administrative department in the provincial people's government shall scrutinize of the contents of the advertisement and make the decision on whether to issue the registered number of approval for the veterinary drug advertisement. The advertisement content shall be in line with the indications on the label and instruction book of veterinary drugs. If the application is not approved, it is forbidden to make the advertisement.
Regarding the veterinary drugs ordered to suspend the manufacture, distribution and utilization, it is forbidden to make advertisement in the suspension period; the already published advertisement shall be ceased.
Article 23. Anyone that violates these Implementation Measures shall be punished. If there are stipulations for penalty in the laws and the administrative regulations, these stipulations shall prevail.
Article 24. Where the veterinary drugs manufacturing enterprise accepts the entrustment or consigns another enterprise to process veterinary drugs, it shall be ordered by the veterinary administrative department in the people's government in the provincial people's government to make correction and be imposed upon with a fine of over ten thousand Yuan but less than thirty thousand Yuan.
Article 25. Where the unit or individual for business operation of veterinary drugs has any of the following actions, the party concerned shall be imposed upon with a fine of over one thousand Yuan but less than five thousand Yuan by the veterinary administrative department in the people's government above county level.
(1). refusing the supervision and inspection or the sample inspection;
(2). having no or incomplete purchase and sale records;
(3). failing to implement the divided administration system of the prescription veterinary drugs and the non-prescription ones in accordance with the stipulations of the State;
(4). not conducting the business operation within the scope and site prescribed in the business operation permit for veterinary drugs.
Article 26. Where anyone engaged in livestock breeding has one of the following actions, he shall be ordered by the veterinary administrative department in the people's government above county level to make correction. If he refuses to make corrections, he shall be imposed upon with a fine of less than one thousand Yuan.
(1). fails to set up the medication record or has the incomplete or untruthful record;
(2). does not make use of veterinary drugs in accordance with the stipulations of the State on safety utilization of veterinary drugs;
(3). makes unauthorized use of the narcotics and psychotropic substances in violation of the stipulations of the State on administration of special veterinary drugs.
Article 27. Anyone who utilizes the forbidden drugs and other chemical compounds shall be ordered by the veterinary administrative department in the people's government above county level to make correction and conduct the bio-safety disposal of the livestock fed with the illicit drugs and other chemical compounds and their products; the unit violating this paragraph shall be imposed upon with a fine of over ten thousand Yuan but less than fifty thousand Yuan.
Article 28. Any veterinary administrative department or its working member that abuses his power, neglects his duty, and practice illegalities for private gains shall be imposed upon with an administrative penalty by its administrative department or its superior competent administrative department; If such an action constitutes a crime, the criminal responsibility shall be investigated.
Article 29. The competent administrative department of fishery in the people's government above county level and its subordinate fishery supervision and administration organ shall be responsible for the veterinary drug utilization, veterinary drug residue testing, and its supervision and administration in aquiculture and the administrative penalty over the illegal medication in the procedures of aquiculture,
Article 30. These Implementation Measures shall come into force as of September 1, 2008.