Classification and registration of veterinary disinfectant requirements (Ministry of Agriculture Bulletin No. 442 issued)
First, the registration category
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) natural substances extracted from new and effective monomer and its preparation;
3 The new compound disinfectant.
The second category has been marketed abroad but not yet marketed in China for veterinary disinfectant.
1 by synthetic or semi-synthetic methods obtained the bulk drugs and their preparations;
(2) natural substances extracted from new and 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 up the subject and basis.
4 summarizes the main findings and evaluation.
5 disinfectant manual comp, drafting instructions and the latest references.
6 packaging, label design comp.
(B) pharmaceutical research data
7 disinfectant production technology of information 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. Veterinary standards and the drafting of the draft instructions, and provide veterinary standard or control substance.
11. The source of materials and quality standards.
12 samples of physical and chemical indicators of test report.
13 drug stability studies of experimental data 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 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 registration project description
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 include: common 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 patents and their ownership of process status description, as well as others does not constitute patent infringement guarantee;
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 the study 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 reference: according to the Ministry of Agriculture, including the drafting of the relevant provisions of the manual comp, the content of the draft manual instructions related to the latest literature or 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 impurities or other 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 of such purity and formulation basis.
10 items tested 12 samples of physical and chemical indicators 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 studies of drug stability test data include: 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) mutagenesis test, (8) sub-chronic toxicity tests, (9) Teratogenicity test (10) chronic toxicity test (11) cancer test.
13 items 23 samples GERMICIDAL test data include: (1) The effect of laboratory test data to kill micro-organisms, (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 disinfectant in the administration of animal tissues is residual, the degree of residual and residual time. Veterinary drug residues should indicate 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 projects require animal food animal body surface or disinfectant registered with the classification and data entry requirements
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 note refers to the Article 5.
(B) Description
1 disinfectant disinfectant and food sub-environment or animal body surface disinfectant with animals, they registered the same classification.
2 Press the declaration order of data items, a new application for registration of environmental disinfectant, according to "list of items for disclosure of information" requirement to submit items 1 to 20, 22 to 24; application for registration or for use in food animals, with animal body surface disinfection 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 the 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 application in accordance with the provisions of Category 2 and submit registration 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 in the country (region) listed the use of packaging, labeling is kind.
3 data item 24 shall be submitted to the veterinary drug manufacturers in the country (region) for the sale and application of all environmental toxicity studies for the information.
4 All declarations 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. Veterinary quality standards of the Chinese version, must comply with the Chinese veterinary standard format.
(B) items 2 to prove the requirements and specifications documents
1 items 2 proof documents include the following information:
(1) Manufacturer country (region) issued by the veterinary authorities to allow sale and the veterinary disinfectant manufacturers comply with good manufacturing practices of the veterinary certificate, notarized documents and its Chinese translation;
(2) manufacturer based in China by the foreign registration affairs representative, should provide a "representative offices of foreign companies based in China Registration Certificate" copy.
Overseas manufacturers agents commissioned by the Chinese agency report, the commission shall provide the documents, notarized documents and their Chinese translation, and the Chinese agency's "business license" copies;
(3) for the prescription or use of disinfectants, such patents and their ownership of process status description, as well as others does not constitute patent infringement guarantee.
2 Description:
(1) Manufacturer country (region) issued by the veterinary authorities to allow sale and the veterinary disinfectant manufacturers comply with good manufacturing practices of the 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 of the veterinary certificate ;
(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 veterinary drug manufacturers comply with good manufacturing practices veterinary certificate from the manufacturer of the 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 good manufacturing practices documents.