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Amendments To The Cabinet Of Ministers Of 22 January 2013 By Regulation No 52 "rules For Scientific Purposes The Protection Of Animals Used"

Original Language Title: Grozījumi Ministru kabineta 2013. gada 22. janvāra noteikumos Nr. 52 "Noteikumi par zinātniskiem mērķiem izmantojamo dzīvnieku aizsardzību"

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Cabinet of Ministers Regulations No. 368 in 2017 in the 27 June (pr. No 32 33) amendments to the Cabinet of Ministers of 22 January 2013 by Regulation No 52 "rules for scientific purposes the protection of animals used" Issued under the Animal protection law paragraph 4 of article 10 and article 24.2 do cabinet January 22, 2013 the Regulation No 52 "rules for scientific purposes the protection of animals used" (Latvian journal, 2013, no. 24) the following amendments: 1. Supplementing Chapter VIII with 89.1 points the following : "the user of the test animal 89.1, which have received the permission of the pilot project for the use of animals in procedures, and test the keeper who cultivates genetically modified animals that have intentionally created and gets a harmful phenotype, service to 1 March of the current year by electronic report on the use of animals in procedures in the previous year in accordance with the provisions of annex 7." 2. Add to paragraph 134 of the rules with the following wording: "134. report on the experimental use of animals in procedures 2016 experimental animal user and test the keeper shall provide service up to august 31, 2017." 3. To supplement the provisions of annex 7 (annex). Prime Minister Māris kučinskis agricultural Minister, the Defense Minister Raimonds Bergmanis Ministry of Agriculture presented the attachment Cabinet 27 June 2017 regulations no 368 "Annex 7 Cabinet January 22, 2013 the Regulation No. 52 report on the use of experimental animals in the information to be included in the procedure i. General information 1 Id1-indicates animals user registration number. 2. the Id2-indicates the pilot project authorization number. If the pilot project includes a number of procedures, then behind the project authorization number indicates the procedures pursuant to the order, what is the test project. 3. Id3-indicates A or B (A – if the procedure is not the severity changes, B – if the procedure is the severity changes). 4. Enter data for each animal and each use of the procedure. 5. Enter data for the same category of animal, choose only one option. 6. For animals which have been killed for organs and tissues, as well as the indikatordzīvniek data are not to be provided, unless the animals are not killed, in accordance with the project authorisation, using this provision included in annex 6 method, or in addition to the manipulation has not been carried out, which is not directly related to the killing and tissue acquisition. 7. not Nonāvēto animals used are not included in the data, excluding genetically modified animals that have intentionally created and gets a harmful phenotype. 8. kāpurform records of animals when they are able to feed themselves. 9. Mammal species of fruit and embryonic forms not listed. Lists the only born and live animals, including caesarean born of animals. 10. If with or without the prior authorization has exceeded the severity "ceiling", these animals and their use in the report reflect the same as in other use cases, and apply the category "heavy". 11. Data reflects its annual report in which ends the procedure. The review of trials to be submitted in the second calendar year, all animals can reflect together last year in the end of the procedure. Report on the pilot projects, lasting more than two calendar years, reflecting that year when they killed or they die. 12. If you use the category "other" in the descriptive part of the imperative to provide detailed information.
II. information on the genetically modified animals 13. Review column "genetically modified animals" indicates animals genetically modified (transgenic, gene inactivation and other genetic transformation methods), and animals with natural or induced the mutations. 14. the report reflects the genetically modified animals are used: 14.1. creating a new line; 14.2. to maintain a solid line that you intentionally create a harmful phenotype, and it gets; 14.3. in other (scientific) procedures, rather than lines or maintenance. 15. All animals which is the genetic modification of the media, the report reflects when you create a new line. The report also reflects the animals used in the superovulācij, the vazektomij, the implantation of the embryo (the animals themselves may or may not be genetically modified). Not be reflected in the context of a new genetically modified lines occurred creating genetically normal animals (wild type progeny). 16. new lines of genetically modified animals used to create a category of "objectives" reflects the establishment of objectives at the line either "fundamental research", or "Practical research and applied research" category. 17. A new genetically modified animal strains, or line is considered "stable" when the genetic modification is stabilized (it requires at least two generations) and has completed the assessment of welfare. 18. assessment of welfare is determined, or the newly created line is expected to create a deliberately harmful phenotype, and, if so, of the current report reflects the animals category "a stable colony of genetically modified animals, which are not used in other procedures" or, where appropriate, to the other procedures, where these animals are used. If welfare assessment concludes that the line is not expected to be harmful to the phenotype, its cultivation is out of procedure and report no longer reflect. 19. Category "a stable colony of genetically modified animals, which are not used in other procedures" cover animals that are necessary to maintain the colony with genetically modified stable line of animals, which has deliberately created a harmful Phenotype and genotype in which harmful are experienced pain, suffering, discomfort, or lasting harm. The proposed line maintenance is not intended to indicate. 20. All genetically modified animals are used in other proceedings (not genetically modified lines or maintenance), the report reflects the appropriate purpose (as well as non-genetically modified animals). These animals can have or not have a harmful phenotype. 21. the genetically modified animals that are harmful to the Phenotype and gets you killed to get from them the organs and tissues, the report reflects to the relevant primary objectives, having these organs or tissue is used.
III. Information on the use of animals in comparison to the sustainable use of

22. the use of animals for scientific, experimental one, for the purpose of education or training lasts from the time the animal for the first method, until you have completed data collection, observation or educational goal is reached. Usually this is one experiment, test, or the practice of the method. 23. One procedure can include multiple stages (methods), all of whom are necessarily associated with one result, and which use the same animal. 24. the user of the animals in the report reflect the whole procedure, including the preparation of any kind (regardless of where it happens), and shall take into account the suffering associated with the preparation. 25. examples of preparation is surgical procedures (e.g., cannula, entering the devices implanted with telemetric recorders, ovariektomij, castration, hipofizektomij) and procedures without surgical intervention (such as a modified feed izēdināšan, diabetes causing). The same applies to genetically modified animals, that is, if the animal used for the intended procedure, the end user report reflects the whole procedure and take into account associated with the phenotypic severity. For more information see the section on genetically modified animals. 26. If the animal is not used to prepare a scientific purpose, but the preparation of the animal is exceeded this rule 5.6. the deadline laid down in pain, suffering, discomfort, and lasting damage to the minimum level, the institution that prepared the animal, report on the intended target should reflect information about preparation as an independent procedure.
IV. filling order statistics 27. Fill the column, indicating the types of animals (table 1): 27.1. all species of cephalopod, under the title of the report "Cephalopod" reflects from the stage when the animal becomes unable to feed themselves, i.e., Octopus and squid immediately after hatching and sepia approximately seven days after hatching; 27.2. fish reflect the stages when they are able to feed themselves. Zebrziv, kept for breeding under optimal conditions (approx. + 28 C), count five days after fertilization. 27. table 1 animal 27.1. Mouse (Mus muscul) 27.2. Rats (norvegicus Ratt) 27.3. Guinea pigs (the Cavi porcell) 27.4. Golden hamsters (in Mesocricet auratus) 27.5. Chinese hamster (Cricetul griseus) 27.6. Sand mouse (Marion's unguiculata) 27.7. other rodents (other Rodenti) 27.8. Rabbits (Oryctolagus-curicul) 27.9. cats (Felis cat) 27.10. Dogs (Canis familiar) 27.11. Ferrets (Mustela putori furo of) 27.12. other Carnivora (other Carnivor) 27.13. Horses , asses and intersection (Wild) 27.14. pigs (Sus scrofa domesticus) 27.15. Goats (Capra aegagrus hircus) 27.16. Sheep (Ovis aries) 27.17. Bovine (BOS primigeni) 27.18. Prosimian (Prosimi) 27.19. Kalitriks and tamarīn (e.g. jacch Callithrix) 27.20. Long-tailed macaques (the fascicular Macac) Rhesus Macaques 27.21. (a mulatto Macac) 27.22. Green monkey Chloroceb spp. (usually pygerythr or sabae) 27.23. Baboon (the Papi spp.) 27.24. Vāverpērtiķ (e.g. sciure, Saimir) 27.25. other primates of the genus, except human primates (Ceboide and other Cercopithecoide species) 27.26. Hominidae (Hominoide) 27.27. Other mammals (other Mammali) 27.28. Domestic fowl (Gallus gallus domesticus) 27.29. Other birds (other Av) 27.30. Reptiles (Reptili) 27.31. Rana (Rana pipiens and Rana temporari) 27.32. Frogs (Xenop laevis and Xenop of tropical) 27.33. other amphibians (other Amphibi) 27.34. Zebrziv (Danio rerio) 27.35. Other fish (another PISCES) 27.36. Cephalopods (Cephalopod) 28. Box the repeated use of animals (scheme) : 28.1. each time to use animals in the report reflect each at the end of the procedure; 28.2. the above is the number of animals used in the statistics reflect only in relation to the species and birth location, so reuse animals does not indicate the place of birth; 28.3. the report reflects the real suffering of animals during the procedure. In some cases they can be influenced by previous use, but this does not mean that the next time you use the suffering is always the hardest, and sometimes they even reduce habituation. Therefore, the severity is not determined by summing the previous times the severity. The severity of pain in each case is assessed individually. 29. Box the birth place: 29.1. Animals born at the EU registered breeder 29.2. Animals born in the EU, but not at the registered keeper's 29.3. Animals born in the rest of Europe 29.4. Animals born in the rest of the world 29.1. indicate where the animal was born, rather than the place from where it is shipped; 29.2. sub-category "animals born in the EU at the registered keeper" includes animals born at the experimental animal breeders that have been granted access and which are registered with the competent authority of the European Union, in line with existing laws on animals used for scientific purposes; 29.3. sub-category "animals born in the EU, but not at the registered keeper" contains animals that have not been born to registered keepers of animals, such as wild animals, farm animals (except where permission has been granted to the grower and it is registered), as well as animals, to which apply the exemptions in accordance with the provisions of paragraph 14; 29.4. subcategories "animals born in the rest of Europe" and "animals born in the rest of the world" includes all animals, whether or not they raised at the registered keeper of the animals or elsewhere, as well as wild animals captured. 30. Box the Primate, Primate of the genus except man, origin: 30.1. Animals born to registered breeder animals EU 30.2. born in the rest of Europe 30.3. Animals born in Asia 30.4. Animals born in America 30.5. Animals born in Africa 30.6. Animals born elsewhere

30.1. sub-category "animals born at the registered keeper of the EU" to be born in the European Union; 30.2. sub-category "animals born in the rest of Europe" to Turkey, Russia and Israel born animals; 30.3. sub-category "animals born in Asia" to be born in China; 30.4. sub-category "animals born in America" included in North, Central and South America-born animals; 30.5. sub-category "animals born in Africa" to be included in the Mauritius-born animals; 30.6. sub-category "animals born elsewhere" to animals born in Australasia. 31. Box the primates, with the exception of primates, human generation: F0 F1 F2 or next to the colony Self-sufficient 31.1. as long as the colony is not self-sufficient, in the colony of the animals still reflect the subcategories "F0", "F1", "F2" or next generation, which descended through the mother's line; 31.2. as soon as the entire colony becomes self-sufficient, all animals born in this colony represents a subcategory of "a Self-sustaining colony" regardless of the generation, which descended through the mother's line.
32. Box the genetic condition: 32.1. no genetically modified 32.2. Genetically modified without harmful phenotypic 32.3. Genetically modified with a harmful phenotype 32.1. sub-category "not" genetically modified "includes all animals that have not been genetically modified, genetically normal parents who used new genetically modified lines or the creation of strains; 32.2. sub-category "genetically modified without harmful phenotype" includes animals that are used to create a new line, which is the genetic modification of the media, but which are not harmful to the phenotype elicited, and genetically modified animals that are used in other procedures, not to create or maintain the line, but harmful to the phenotype not gets; 32.3. in the subcategory "genetically modified with a harmful phenotype" include: 32.3.1. animals which are used to create a new line, and which gets a harmful phenotype; 32.3.2. animals used in the maintenance of a stable line, which has deliberately created a harmful phenotype, and which gets a harmful phenotype; 32.3.3. genetically modified animals that are used in other procedures, not to create or maintain the line and gets a harmful phenotype. 33. Box the new genetically modified lines. In the subcategory "animals used for new genetically modified lines or strains to create" includes animals that are used for new genetically modified line or strain, and they are separated from the other animals used for fundamental research "or" Practical research and applied research "needs.
Animals used for new genetically modified lines or the establishment of 34 strains in box "gravity" indicates the type of procedure under these regulations, paragraph 49 and annex 5.
35. The column "purpose": 35.1. Fundamental research and practical research of 35.2. applied research 35.3. Using regulatory purposes and the production of rutīnveid 35.4. the protection of the natural environment, human or animal health or welfare in the interest of saving species 35.5 35.6. higher education or vocational training, maintenance or improvement of training for 35.7. judicial medical examination 35.8. stable genetically modified animal colony maintenance, not used in other procedures

35.1. sub-category "' fundamental research ' include animals used for fundamental studies of the nature, including Physiology studies. They are studies designed to improve knowledge of living organisms, and the normal and abnormal environment structure, functioning and behavior, including fundamental research in toxicology, including research and analysis, focused on a subject, or a natural phenomenon of the basic law better or fuller understanding, rather than on the results of specific practical applications: 35.1.1. animals are used when creating (also with a two-line crossover) new genetically modified animal line for use fundamental research needs (for example, the developmental biology, immunology), the report reflects adequately the purpose for which the line was created, the category of "creating a new genetic line, which used new genetically modified line/strain of creation"; 35.1.2. the report reflects all animals that are genetic modifications of the media and are used to create a new line. This category is also reflected in the report which are used in the process, such as superovulācij, vazektomij and embryo implantation. The report does not include non-genetically modified (wild type) descendants. A new genetically modified animal strains, or line is considered "stable" when the genetic modification is stabilized (it requires at least two generations) and has completed the assessment of welfare; 35.2. sub-category "Practical research and applied research" includes animals that are used according to the animal protection act article 25, paragraphs 2 and 3, the exception laid down in the regulatory objectives: 35.2.1. practical research and applied research also owns the discovery-oriented studies and toxicity, the purpose of which is to prepare for the marketing authorisation application or develop a method other than research, which is indispensable to the marketing authorisation for submission of the application. Animals used in creating (also with a two-line crossover) new genetically modified animal line for use in practical research and applied research needs (for example, cancer research, vaccine development), the report reflects, according to which they are created, the category of "creating a new genetic line, which used new genetically modified line/strain of creation"; 35.2.2. the report reflects all animals that are genetic modifications of the media and are used to create a new line. This category is also reflected in the report which are used in the process, such as superovulācij, vazektomij and embryo implantation. The report does not include non-genetically modified (wild type) descendants. A new genetically modified animal strains, or line is considered "stable" when the genetic modification is stabilized (it requires at least two generations) and has completed the assessment of welfare; 35.3. in the subcategory "regulating the use and production of rutīnveid" (by type) include animals used in fulfilling the requirements of the law of procedure in relation to the product or substance for the production and placing on the market, including maintenance and food and feed safety and risk assessment. This includes the submission of a marketing authorisation to be taken for tests on products and materials that do not require a marketing authorisation that is, tests with the products or substances which have not been completed. This subcategory includes also animals used in the manufacturing process of the product, when it is necessary for regulatory approval (such as animals, used in the manufacture of the medicinal serum type). This subcategory is not subject to testing the effectiveness of new drug development, and the report reflects in the subcategory "Practical research and applied research"; 35.4. sub-category "natural environment, human or animal health or welfare interest ' includes studies aimed at exploring and understanding the phenomena such as environmental pollution, biodiversity loss, as well as epidemiological studies of wild animals. This subcategory does not cover the use of animals for regulatory purposes; ecotoxicology 35.5. a subcategory of "conservation" includes animals that are used for the conservation of the species procedures; 35.6. sub-category "higher education or vocational training, maintenance or improvement of training for" includes training, which acquires and maintains the practical responsibilities pursuant to that provision and paragraph 41.42; 35.7. in the subcategory "medical investigation" include animals used in judicial investigation necessary medical procedures; 35.8.: "a stable colony of genetically modified animals, which are not used in other procedures" indicates the number of animals needed to maintain the colony with genetically modified stable line of animals, which has deliberately created a harmful phenotype, and having been a harmful phenotype due to pain, suffering, discomfort or injury sustained, without specifying the line maintenance. This sub-category does not include animals that need new genetically modified lines, and other animals used in procedures, rather than lines or cultivation. 36. The column "fundamental research": 36.1. Oncology. Cardiovascular System 36.2 (blood and limfrit) 36.3. Nervous System 36.4. Respiratory system, Gastrointestinal system, 36.5. also liver 36.6. Musculoskeletal System 36.7. Immune system and reproductive 36.8. Uro System 36.9. Sensory organs (skin, eyes, and ears) 36.10. Endocrine System and metabolism of 36.12. Multisistēmisk 36.11. Ethology, animal behavior and animal biology 36.13. other

36.1. sub-category "Oncology" indicates all the studies in the field of Oncology regardless of migration towards; 36.2. in the subcategory "Cardiovascular System" indicates all the studies on blood circulation and limfrit; 36.3. in the subcategory "nervous system" indicates all the research in neuroscience and psychology, as well as the peripheral or central nervous system; 36.4. sub-category "respiratory system" indicates all the studies on the respiratory system; 36.5. sub-category "Gastrointestinal system, liver" indicates all the research on the gastrointestinal system; 36.6. sub-category "musculoskeletal system" indicates all the research on muscle and skeletal system; 36.7. sub-category "immune system" indicates all the research on the immune system; 36.8. sub-category "URO and reproductive system" indicates all the research on the Uro and reproductive system; 36.9. to subcategory "sensory organs (skin, eyes, and ears)" relevant research on the nose include subcategory "respiratory system" and research on tongue-a subcategory "Gastrointestinal system, liver"; 36.10. sub-category "endocrine system and metabolism" indicates all the studies on the endocrine system and metabolism; 36.11. in the subcategory "Multisistēmisk" indicates only those studies, the primary interest of more than one system, for example, some infectious diseases, and does not include onkoloģisko studies; 36.12. sub-category "ethology, animal behavior and animal biology" includes both living in the wild and captive animals studies, whose main purpose is to gain more knowledge about the species concerned; 36.13. sub-category "other" refers studies that are not associated with any of the above organs or systems or organ or system is not specific; 36.14. animals used for infectious agents, vectors and neoplasms the manufacture and maintenance of animals used in other biological material, and animals used for Polyclonal Antibody production in practical research or applied research purposes, except for the production of monoclonal antibodies to the ascīt method (which refers to a subcategory "regulating the use and production of rutīnveid (by type)"), the report reflects the relevant category "basic research" or "Practical research and applied research" fields. Research objectives indicate exactly because of the interest can be a subcategory of both categories, but the report reflects only the main target.
37. The column "Practical research and applied research": 37.1. Human Cancer 37.2. Human infectious diseases. The human cardiovascular system 37.3 disorder 37.4. The human nervous system and mental disorders 37.5. the respiratory system of Human disorders. The human gastrointestinal 37.6 system disorders, liver disease also 37.7. Human musculoskeletal system disorders 37.8. Human immune system disorders 37.9. Human and Uro-reproductive system disorders 37.10. Human sensory organs (skin eye and ear) 37.11. Human diseases endocrine and metabolic disorder 37.12. other human disorders and diseases 37.13. disorders 37.14. Animal welfare 37.15. diagnosing Disease plant disease 37.16.37.17. regulatory purposes not related With the toxicology and ecotoxicology of 37.1. sub-category "human cancer" and "human infectious disease" indicates any fundamental research independently of the migration towards; 37.2. excludes the use of animals in regulatory purpose, such as carcinogenicity studies for regulatory purposes; 37.3. studies on nasal diseases included in the subcategory "human respiratory system disorders" and research on diseases of the tongue in the subcategory "the human gastrointestinal system disorders, also liver disease"; 37.4. sub-category "disease diagnosis" include animals used in diseases such as rabies or botulism, direct diagnosis, but it does not apply to animals used in accordance with the laws of animals used for scientific purposes; 37.5. sub-category "regulatory objectives of Toxicology and ecotoxicology unrelated" also includes the findings of Toxicology and research-oriented, the purpose of which is to prepare for the marketing authorisation application or develop a method. This sub-category does not fit with the regulatory requirements established for submitting the data required for the study (feasibility studies, the maximum tolerated dose studies); 37.6. animal welfare Animal protection law covers article 25 paragraph 2 specified in subparagraph "c"; 37.7. animals used for infectious agents, vectors and neoplasms the manufacture and maintenance of animals used in other biological material, and the animals used for the production of Polyclonal Antibody for practical research and applied research for purposes other than the production of monoclonal antibodies to the ascīt method (which refers to a subcategory "regulating the use and production of rutīnveid (by type)"), the report indicates the relevant category "basic research" or "Practical research and applied research" fields. The goal of the research is determined accurately because of the interest can be a sub-category of both category, but the report reflects only the main target. 38. The use of the regulatory objectives and rutīnveid production: 38.1. the use of animals in procedures legislation for scientific purposes the protection of animals used for the enforcement of the requirements relating to the product and the production and the placing on the market, and food and feed safety and risk assessment; 38.2. the tests with the products and substances, which had been expected to submit a request for a marketing authorisation, but something the developer ultimately considered it inappropriate for the market, so their development is not finished. 38.3. also includes the animals used in the production of the product, when the production process requires regulatory approval, for example, the animals used in the serum type medicine production. 39. The box "use regulatory purposes and the production of rutīnveid (by type)" does not include a new drug development of efficacy during tests that the report reflects the category of "Practical research and applied research": 39.1. Quality control (also lots of safety and strength testing) 39.2. other efficacy and tolerability testing 39.3. Toxicity tests and other safety tests, including Pharmacology 39.4. Rutīnveid production

39.1. sub-category "quality control" include animals that were used in the finished product and its ingredients purity, potency, stability, strength and other parameters of quality control testing relating to production during any control for the purpose of registering to comply with any other national or international law of animals used for scientific purposes in the field of protection or comply with the policy defined by the manufacturer. This subcategory includes pirogenitāt tests; 39.2. sub-category "other efficacy and tolerance tests" includes a biocide and pesticide efficacy testing, as well as animal nutrition additives used in tolerance testing; 39.3. sub-category "toxicity tests and other safety tests" (including medicine, dentistry, and veterinary medicine and medicinal product safety evaluation of devices) include research on any product or substance in order to determine whether the product or substance when it is used or produced in the manner provided for or abnormally or when it is suspected or real environmental pollutant, can not be dangerous or undesirable effects on human beings or animals; 39.4. sub-category "Rutīnveid production" includes a monoclonal antibody (the ascīt method) and blood products, Polyclonal Antisera production well with existing methods. This subcategory does not include animal hybridoma production of imunizēšan, and it reflects the relevant column of the "fundamental research" or "Practical research and applied research" subcategory. 40. The column "legal test": 40.1. The legislation on medicinal products for human use 40.2. Legislation on veterinary medicinal products and their residues 40.3. Legislation on medical devices, 40.4. Legislation on industrial chemicals 40.5. the law on plant protection products 40.6. Legislation on biocides 40.7. Legislation on food, also on materials in contact with food 40.8. The legislation on animal feed also on the target, the safety of workers and the environment 40.9. Legislation on cosmetic products 40.10 other 40.1. legislation on animals used for scientific purposes the protection requirements according to the indicate the intended primary use; 40.2. the water quality testing, if it applies, for example, to tap water, indicates the category ' legislation on food ". 41. The column "legal requirements" indicates that the legislation on scientific purposes the protection of animals used are respected: 41.1. the law governing the EU requirements 41.2. the law which determines the level of the Member States only requirements (European Union) 41.3. Legislation which imposes requirements outside the EU only 41.1. If the field of the protection of experimental animals is regulated by European Union legislation, fill in the column "legislation, which defines the requirements of the EU" including all international requirements, which meet European Union requirements (e.g. testing in accordance with the ICH and VICH, Organisation for economic cooperation and development (OECD) guidelines, monographs of the European Pharmacopoeia); 41.2. the box "legislation, which determines the level of the Member States only requirements (European Union)" completed only if the test meets the requirements of more than one Member State. This country does not necessarily need to be the country in which the work in question; 41.3. box "legislation which imposes requirements only outside the EU" filled in when the European Union used for scientific purposes in the field of animal protection is not equivalent to the requirements of the test.
42. The columns ' quality control (also lots of safety and strength tests) in the subcategory "party" safety tests "does not include pirogenitāt tests. These tests report indicates a separate subcategory "Pirogenitāt test".
42.1. the safety tests of the party 42.2. Pirogenitāt tests the strength of the party's 42.3. tests 42.4. other quality control measures 43. The column "toxicity tests and other safety tests by test types": 43.1. Acute (single dose) toxicity test methods (including threshold detection test) 43.2. Skin irritation/corrosive effects on skin 43.3 43.4.. skin sensitisation eye irritation/corrosive effects on the eye 43.5. Repeated dose toxicity carcinogenicity 43.7 43.6.. Genotoxicity 43.8. Reproductive toxicity Developmental toxicity of 43.9.43.10. Neurotoxicity 43.11. Kinetics (pharmacokinetics , toxicokinetics, residue degradation) 43.12. Pharmaco-Dynamics (including safety pharmacology) 43.13. Phototoxicity-43.15. Ecotoxicity 43.14. Food and feed safety tests safety target of 43.16.43.17. other 43.1. imūntoksikoloģij studies included in the subcategory "repeated dose toxicity"; 43.2. toxicokinetics in relation with regulatory objectives are made for repeated dose toxicity studies, the report represents the subcategory "repeated dose toxicity"; 43.3. in the subcategory "food and feed safety tests" includes potable water testing (including testing for reliability target); 43.4. sub-category "security" target include tests that verify a specific animal products can be safely used in other specimens of the species concerned (except for the safety tests of the party, which includes the category of "quality control").
44. The column "acute and sub-acute toxicity test methods" indicates the LD50, LC50 44.2:44.1.. other methods of lethal non-fatal methods 44.3.45. The column "repeated dose toxicity": 45.1.28 days and less 45.2.29 to 90 days more than 90 days 45.3.46. The column "animal use regulated production (by product type)" indicates: 46.1.46.2. Blood products of monoclonal antibody 46.3. other 47. The column "Eco" indicates : 47.1 47.2. acute toxicity Chronic toxicity. 47.3. reproductive toxicity 47.4. Endocrine activity. Bio-accumulation 47.6.47.5 (scheme) of Agriculture Minister, the Defense Minister Raimonds Bergmanis