Classification and registration of veterinary disinfectant requirements (Ministry of Agriculture Bulletin No. 442 issued)



First, the registration categories
The first category is not listed in the domestic and international sales of veterinary disinfectants.
1 by synthetic or semi-synthetic methods obtained the bulk drugs and their preparations;
2 new natural substance extracted from the effective monomer and its preparation;
3 The new compound disinfectant.
The second category has been marketed abroad but not yet marketed in China's veterinary disinfectant.
1 by synthetic or semi-synthetic methods obtained the bulk drugs and their preparations;
2 new natural substance extracted from the effective monomer and its preparation;
3 The new compound disinfectant.
The third change has been marketed at home and abroad prescription, dosage and other disinfectants.
Second, the registration program
(A) Summary information
1 disinfectant name.
2. Proof documents.
3 and based on established topics.
4 summarizes the main findings and evaluation.
5. Disinfectants manual comp, drafting instructions and the latest references.
6 packaging, label design comp.
(B) pharmaceutical research data
7 disinfectant production process of research data and literature.
8 confirmed the chemical structure or components of the experimental data and literature.
9. The quality of test data and research literature.
10 draft standards and draft veterinary instructions and provide veterinary standard or control substance.
11 sources of materials and quality standards.
12 samples of physical and chemical indicators of the inspection report.
13 trials of drug stability information and literature.
14 direct contact with the veterinary drug packaging materials and containers of choice basis.
(C) Toxicology Data
15. Toxicology data and literature review.
16 Acute toxicity studies of test data and literature.
17 Long-term toxicity test data and literature.
18. Mutagenicity test data and literature.
19. Reproductive toxicity test data and literature.
20. Carcinogenicity test data and literature.
21. Hypersensitivity (local and systemic) and local (skin, mucous membranes, etc.) and other major irritation associated with the local special security disinfection pilot study and literature.
22. Compound disinfectant disinfection in a variety of ingredients, toxicity testing data and mutual influence of literature.
(D) test and residual disinfection research data
23 samples GERMICIDAL experimental data.
24. Environmental toxicity testing data and literature.
25. Residue research data.
Third, the description of the project registration
1 disinfectants and disinfectant into the environment with animal disinfectants. Environmental disinfectants do not need to provide information item 25.
2 items a veterinary disinfectant name: including generic name, chemical name, English name, Pinyin, and indicate its chemical structure, molecular weight, formula, etc. The name of the new development should be named according to instructions.
3 items 2 proof documents:
(1) the applicant legal registration documents, "veterinary drug production license", "Certificate of GMP" copy;
(2) for the prescription or use of disinfectants, such as patent process and its ownership status descriptions and the patents of others does not constitute a guarantee for infringement;
4 items 3 and based on the subject of legislation: the disinfectant, including domestic and foreign research and development, use and related documents or the production, usage overview.
5 Data Item 4 summarizes the results of research and evaluation: including the applicant for a summary of major research results, and from the safety, efficacy, quality control and other aspects of the comprehensive evaluation of the reported species.
6 items 5 disinfectant manual comp, drafting instructions and the latest references: include the drafting of relevant regulations by the Ministry of Agriculture's manual comp, manual drafting of the contents of the note, or the latest literature related to the latest version of the original manufacturers invented the original and official guide Chinese translation.
7 Data Item 7 of the API production process of research materials and literature: including process and chemical reaction, the starting material and organic solvent, reaction conditions (temperature, pressure, time, catalyst, etc.) and operating procedures, methods and refined the main physical and chemical constants, and indicate the feeding amount and yield and process that may arise during or mixed with other impurities or intermediates. Preparation should be provided and the basis for formulation of disinfectants.
8 items 9 quality test data and research literature include: physical and chemical properties, purity checks, determination and methodology of research and verification.
9 items 10 veterinary standards and the drafting of the draft instructions, and provide reference materials or control substance: quality standards should be consistent with the "China Veterinary Pharmacopoeia" The current version of the format, and use its terminology and units of measurement. Reagent used, the test solution, buffer, titration, etc., should be a "China Veterinary Pharmacopoeia" The current version of the closed set of species and concentration, there are different, should be detailed. Provide standard or reference substance shall be attached information on their sources, physical properties, purity, concentration and determination methods and data. Veterinary standards drafting instructions should include control of project selection criteria, methods, selection, inspection, and limits the scope of purity and development basis.
10 items 12 samples of physical and chemical indicators of the inspection report: refers to the declaration of the sample inspection reports, including the results of determination of active ingredients, pH, measurement results, the chemical stability of the test results, metal corrosion test results.
11 items 13 drug stability studies of experimental data: including the use of direct contact with drug packaging materials and containers together the qualitative test.
12 items 15 to 20 disinfectant toxicological safety testing data: Refer to "Identification of technical guidelines disinfectant." Including (1) acute oral toxicity test, (2) acute inhalation toxicity test, (3) acute skin irritation test, (4) Acute eye irritation test, (5) skin allergy test, (6) sub-acute toxicity test data , (7) mutation test, (8) sub-chronic toxicity tests, (9) teratogenic test, (10) chronic toxicity test (11) cancer test.
13 items 23 samples GERMICIDAL test data include: (1) Laboratory of Microbial killing effect of test data, (2) a variety of factors (such as temperature, pH, organic matter, etc.) Effect on microbial killing test data , (3) biological stability test data, (4) field test data and simulated field test data, (5) energy experimental data.
14 items 24 environmental toxicity testing data and literature: is the application of drugs on the environment, aquatic life, plants and other non-target fauna.
15 items 25 residue research data; is used in food animals and livestock disinfection with a disinfectant in the administration of animal tissues is residual, the degree of residual and residual time. Should indicate the residues of veterinary drugs markers, residual target tissue, daily intake, maximum residue limits. Should also be noted in the recommended conditions of use in the administration of animal tissues is residual, and determine the need to comply with the withdrawal period, and the residue detection method.
Fourth, the registration list and description of
(A) the registration list
Data
Segment information
Registered disinfectant classification project environment
And information requirements of food items with animal animal body surface or disinfectant classification and registration requirements of data items
123 123
Overview
S 1 + + + + + +
2 + + + + + +
3 + + + + + +
4 + + + + + +
5 + + + + + +
6 + + + + + +
Pharmacy
Study
Data 7 + + + + + +
8 + + + + + +
9 + + + + + +
10 + + + + + +
11 + + + + + +
12 + + + + + +
13 + + + + + +
14 + + + + + +
Toxicology
Study
Data 15 + + + + + +
16 + ± - + ± -
17 + ± - + ± -
18 + ± - + ± -
19 + ± - + ± -
20 + ± - + ± -
21 - - - * 5 * 5 * 5
22 * 4 * 4 - * 4 * 4 -
Residues of materials testing and disinfection 23 + + + + + +
24 + ± - + ± -
25 - - - + ± -
Note: (1 )"+": information that must be submitted;
(2 )"±": literature review that can be used instead of experimental data;
(3 )"-": reported data that can be free;
(4 )"*": follow the instructions to submit the required information, such as * 5, see the illustration refers to Article 5.
(B) Description
1 disinfectant disinfectant and food sub-environment or animal body surface disinfectant with animals, they registered the same classification.
2 items for disclosure of information by the order, apply for registration with the new environment disinfectant, according to "list of items for disclosure of information" requirement to submit items 1 to 20, 22 ~ 24; application for registration or for use in food animals, surface sterilized with livestock sterilization disinfectant, should provide information on items 1 to 25.
3 separate applications for agents, disinfectants API must provide proof of legal sources, including raw material drug production enterprise "business license", "veterinary drug production license", "Certificate of GMP", sales invoices, inspection reports , veterinary standards for data copy. Drug use imported raw materials, should provide "import veterinary certificate of registration" or "veterinary certificate of registration", inspection reports, copies of veterinary standards.
4 is a registered category 1 and 2 in the "new disinfectant compound", shall be submitted to the data item 22.
5 in addition to their respective local administration to submit the appropriate registration category and project information, the information should be submitted to item 21, shall provide local irritation test.
Fifth, the import registration requirements
(A) the registration requirements of the project data
1 declarations in accordance with disinfectant, "disclosure of information project" required to be submitted. Will not be accepted without marketing approval in foreign countries the application of disinfectants; other varieties of applications for registration in accordance with the provisions of Category 2 and submit information.
2 items 5 disinfectant manual comp, drafting instructions and the latest references, manufacturers still need to provide the country (region) veterinary authorities approved the original instructions, in the manufacturer country (region) using the instructions listed on the actual sample , along with Chinese translation. Item 6 still need to provide the disinfectant manufacturer located in the country (region) listed the use of packaging, labeling actual sample.
3 data item 24 shall be submitted to the veterinary drug production enterprise in the country (region) for the sale and application of all environmental toxicity studies for the information.
4. All information submitted shall be in Chinese along with the original, the original non-English information should be translated into English, and English text is attached for reference. In English translation should be consistent with the original.
5 Chinese version of quality standards of veterinary drugs, veterinary drugs must comply with Chinese standard format.
(B) items 2 to prove the required documents and instructions
1 items 2 proof documents include the following information:
(1) Manufacturer country (region) issued by the veterinary authorities and the sale allows the veterinary disinfectant manufacturers comply with good manufacturing practices for veterinary certificates, notarized documents and the Chinese translation;
(2) manufacturer based in China by the foreign representative office registration services should be provided "on behalf of foreign companies based in China Registration Certificate" copy.
Chinese foreign producers commissioned agents reporting agency shall provide the commission documents, notarized documents and their Chinese translation, and Chinese agency "business license" copies;
(3) for the prescription or use of disinfectants, such as patent process and its ownership status description, as well as others does not constitute an infringement of the patent guarantee.
2 Description:
(1) Manufacturer country (region) issued by the veterinary authorities and the sale allows the veterinary disinfectant manufacturers comply with good manufacturing practices of veterinary certificate shall comply with the World Health Organization recommended a unified format. Other file formats must be approved by manufacturer country (region) notary public and manufacturers in the country (region) certification Chinese Embassy;
(2) complete the preparation of a complete production package from another, should provide preparation plant and the packaging plant where the country (region) issued by the veterinary authorities of the veterinary drug manufacturers comply with good manufacturing practices for veterinary documents ;
(3) is not in the manufacturer country (region) marketing approval, and can provide in other countries (regions) on sale of the documents allowed, subject to USDA approval. However, the production of veterinary drugs veterinary manufacturers of quality management practices in line with the supporting documents by the manufacturer country (region) issued by veterinary authorities;
(4) API provides manufacturers the country (region) permit issued by veterinary authorities and the veterinary disinfectant sale veterinary drug manufacturers comply with GMP documents.

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