The Registration Of Veterinary Medicinal Products Order

Original Language Title: Veterināro zāļu reģistrēšanas kārtība

Read the untranslated law here: https://www.vestnesis.lv/ta/id/141448

Cabinet of Ministers Regulations No. 600 in Riga on July 18, 2006 (pr. No 38 44) the order of registration of veterinary medicinal products issued in accordance with article 5 of the law on pharmacy, 3 and 6 of paragraph i. General questions 1. determines the order in which the State Agency of medicines shall record the veterinary medicinal product.
2. The terms used in the following terms: 2.1. drugs-reference veterinary medicinal products registered in a slow-down in the chemical area country or centralized registration procedure of the European Parliament and of the Council of 31 March 2004, Regulation (EC) No 726/2004 laying down the procedures for the authorisation and supervision of medicinal products for human and veterinary use Community procedures and establishing a European Medicines Agency;
2.2. generic medicines – medicines, which has the same qualitative and quantitative composition in active substances and the same pharmaceutical form as the reference medicinal product, and whose bioequivalence with the reference medicinal product has been demonstrated by appropriate bioavailability studies. Active substance salts, esters, ethers, isomers, mixtures of isomers, complexes and derivatives considered as the same active substance, unless they do not possess significantly different characteristics with regard to safety and efficacy or safety or effectiveness. Various forms of medicinal products with a quick release of the active substance for oral use is considered to be one of the pharmaceutical form;
2.3. the finished series of veterinary medicinal products-pharmaceutical form units, made from the same initial quantity of material and have undergone the same manufacturing and sterilization or production or sterilisation. If the production process is continuous, the final series of the veterinary medicinal product is all fixed period the Unit produced;
2.4. the strength: the active substance quantitatively per dose, expressed in units of volume or weight according to the dosage form;
2.5. immunological veterinary medicinal products, veterinary medicinal products used in the animal shelter to those proposed in the active or passive immunity or to diagnose the level of continuity in imun;
2.6. the immunological veterinary medicinal products, veterinary medicinal products which are not logical imuno veterinary medicinal products;
2.7. homeopathic veterinary medicinal products – veterinary medicinal product prepared from the homeopathic stocks (products, substances or compounds) according to homeopathic medicine production method, described in the European Pharmacopoeia or in the pharmacopoeia used officially in the Member States of the European Union (hereinafter referred to as Member States). Homeopathic veterinary medicinal product may contain a number of substances;
2.8. the withdrawal period – the period between the last time in which drugs enter the veterin animals under certain conditions of use, to food production from such animals. This period followed in order to protect public health by ensuring that foods not containing residues in quantities that exceed the maximum residue level established a Council of 26 June 1990 in Regulation (EEC) No 2377/90 laying down a Community procedure for the establishment of maximum residue limits of veterinary medicinal products in foodstuffs of animal origin (hereinafter Regulation No 2377/90);
2.9. generic name: the international non-proprietary name recommended by the World Health Organization (INN) or, failing that, a widely used name.
3. Permitted to distribute veterinary medicinal medicine government agency issued this provision corresponding to annex 1 of the certificate of registration of veterinary medicinal products (hereinafter referred to as the registration certificate) or the European Medicines Agency established by the centralized registration procedure of the European Parliament and of the Council of 31 March 2004, Regulation (EC) No 726/2004 laying down the procedures for the authorisation and supervision of medicinal products for human and veterinary use Community procedures and establishing a European Medicines Agency.
4. the veterinary medicinal product with which medicine Government Agency has issued a certificate of registration pursuant to the requirements of these regulations for more information about this strength, pharmaceutical form, route of administration, design and registration certificate extension (extension of the certificate of registration) the State Agency of medicines shall take a decision on the registration of medicinal products, or on the inclusion of data in the original certificate of registration. This decision includes the original decision on the registration of veterinary medicinal products (notably as regards this provision 22, 23 and 24 of those veterinary medicinal products).
5. These provisions shall not apply to: UR5.1.dz īvniek medicated feedingstuffs as defined in the laws on animal healing and dietary feed. That should be taken into account in preparing animal feedingstuffs, medicated pre-mixes used (medicinal product prepared in advance to make medicated feed animal), established pursuant to the requirements of this regulation;
5.2. inactivated immunological veterinary medicinal products which are manufactured from pathogens and antigens obtained from an animal or the herd life tidbits, and used the said herd or flock in the treatment of animals on the spot;
5.3. in the case of veterinary medicinal products on the base the radioactive isotope;
5.4. in addition, in accordance with the European Parliament and of the Council of 22 September 2003 Regulation (EC) no 1831/2003 on animal nutrition at the doses used have been published in the European Commission's website the register of authorised feed additives, where these additives are added to animal feed and animals more feed;
5.5. veterinary medicinal products intended for research and tests of veterinary medicinal products development;
5.6. in the case of veterinary medicinal products manufactured in a drugstore or for an individual animal animal group according to the veterinarian's prescription prescription, known as the magistral formula;
3.5. medicinal products which are manufactured according to the pharmacy in the Pharmacopoeial monograph and is intended to be supplied directly to the final consumer, and known as the officinal formula.
6. progress of the veterinary medicinal product on the market is the responsibility of the holder of the registration certificate (the owner). The appointment of a representative shall not relieve the holder of the registration certificate (the owner).
7. Veterinary medicinal products intended for food-producing animals (animals, from which the foodstuffs of animal origin), registers, if their composition in active substances are specified in Regulation No 2377/90, annex III (I), (II) or.

8. the holder of the registration certificate (the owner), or, if necessary, the State Agency of medicines shall take the necessary measures to amend the information in the register or in the certificate of registration certificates withdrawn pursuant to the requirements of Regulation No 2377/90, annex III (I), (II) and. Amended or annulled the registration certificate 60dien from the date of the official journal of the European Union published amendments to Regulation No 2377/90, annex I, II or III.
II. Procedures for submitting an application for the registration of veterinary medicinal products licence 9. for the registration certificate, the person to be registered as a name for veterinary medicinal products (hereinafter the applicant), the State Agency of medicines shall be submitted in the application for the registration of veterinary medicinal products (hereinafter referred to as the register of tion application).
10. the registration of the application, the model is published in medicine State Agency website. The registration application is completed, subject to the pharmaceutical law referred to in article 28.1, the European Commission's recommendation that the European Commission has published a European Community regulatory framework for medicinal products in volume VI of "veterinary medicine".
11. application for registration of the certificate of registration of veterinary medicinal products intended for one or more species of food-producing animals containing active substances in respect of these species have not yet been included in Regulation No 2377/90, annex I, II or III, shall be submitted not earlier than six months after submission requirements completed application for such substances maximum residue levels in accordance with Regulation No 2377/90.12. A certificate of registration issued by the State Agency of medicines of the applicant whose registered office is a European economic area country (registered firm, the actual Central Administration or place of business).
13. the application of these provisions, the applicant referred to in paragraph 10, if the application for registration shall be accompanied by the documents that contain the administrative information and scientific documentation necessary to prove to be in the drug safety autism veter, efficiency and quality according to the rules in Appendix 2 (concerning veterinary medicinal imunoloģiskaj) or in annex 3 (in the case of veterinary medicinal imunoloģiskaj) requirements, specifying or adding the following information: 13.1. the applicant's name or business name and the operator's actual or legal address. If a different address, the applicant submits information on veterinary medicinal products, the manufacturer or manufacturers involved in the manufacture of veterinary medicinal products, as well as information on the location of the production area and the actual address;
13.2. name of the veterinary medicinal product (invented name that is not a cam with saja general name, or a generic or a scientific name together with a trade mark or holder of the registration certificate (owner) name);
13.3. veterinary medicinal products, active substances constituting the components of light are assured and analytical indicators. International non-proprietary name recommended by the World Health Organization (INN), if any, or the chemical name of active substances;
13.4. the veterinary medicinal product, the description of the manufacturing method;
13.5. the veterinary medicinal product, therapeutic indications, contra-indications and side effects (adverse reactions);
13.6. given the animal species for which the medicinal products, pharmaceutical form, used horse and route of administration and duration of validity;
8.5. to be precautionary and safety measures to be observed, the Hall of bāj means, the use of the medicinal product in animals or destruction of waste. Indicates possible risks (risk factors related to adverse effects), which can cause to the environment and human, animal or plant health;
13.8. the period to which the product is released from the body of the animal, if the medicinal product intended for Administration to food-producing animals;
13.9. the description of the control methods employed by the manufacturer;
13.10. the results obtained: 13.10.1. pharmaceutical (physico-chemical, biological or micro-biological) tests;
UR13.10.2.dro timeshare tests and residue tests;
13.10.3. non-clinical and clinical trials;
UR13.10.4.izv ērtēj the potential risks of the veterinary medicinal product for the environment. Every possible risks on a case-by-case basis, offering suggestions for this small risk youth;
13.11. detailed use of the veterinary medicinal product on the basis of the effects description of the system and, if necessary, a detailed description of the risk control system, which the applicant intends to implement;
13.12. Description of veterinary medicinal products in accordance with the provisions of paragraph 35;
13.13. instructions on the use of veterinary medicinal products (hereinafter referred to as the instruk of use information), prepared in accordance with the legislation on the labelling of the veterinary medicinal product, distribution and control;
13.14. the primary packaging (containers and other packaging that is in direct contact with the medicinal product concerned) and the secondary packaging (packaging into which is placed the primary packaging) sample is prepared according to the legislation on the labelling of the veterinary medicinal product, distribution and control;
1.15 p.m.. a document showing that the manufacturer of the veterinary medicinal product is authorised in his own country to produce veterinary medicinal products;
UR13.16.re ģistrācij the copies of the certificates attesting the registration of medicines in other countries of the European economic area or in a country other than the countries of the European economic area (hereinafter third country), as well as: 13.16.1.to the European economic area countries list, in which the application for the certificate of registration in accordance with the requirements of these regulations in the examination stage. This list must be added to each list submitted to that State a veterinary medicinal product description (prepared in accordance with the provisions of paragraph 35 or recognised by the competent authority under this rule 51, 52, 53, 54 and 55) copies and copies of the instruction;
13.16.2. information on the negative decision in respect of the veterinary medicinal product, the issue of the registration certificate of the European economic area country or in a third country and the motivation of this decision;
13.16.3.13.16.1. these rules and notified referred 13.16.2. the information that the applicant constitutes, as is additional information on appropriate decisions;

13.17. proof that the applicant has qualified person responsible for pharmacovigilance system according to the regulations on the monitoring of adverse reactions to veterinary medicinal products, and available means for the notification of adverse reactions that may be observed in European economic area countries or in third countries;
13.18. in respect of veterinary medicinal products intended for one or more species of food-producing animals and contains one or more pharmacologically active substances in respect of these species have not yet been included in Regulation No 2377/90 (with subsequent amendments) in annexes I, II or III, the document which certifies that the European Medicines Agency in accordance with the regulation is filed with the application of maximum levels of residues of medicinal products.
14. Registration dossiers in the composition of the veterinary medicinal product contained Cates colours correspond to the provisions referred to in annex 4.
15. The applicant shall ensure that the provisions referred to in paragraph 13.10. bottom test and research results is being prepared a detailed summary. The summary shall be prepared and signed by the person (expert), which according to the technical or professional qualifications set out in the description of life in a short curriculum vitae. The applicant and the expert's expert approved summary of curriculum vitae submitted to the State Agency of medicines.
16. If the applicant pursuant to paragraph 28 of these rules shall be entitled not to submit safety tests and clinical and clinical research results, an expert based in scientific use of information in accordance with this rule 2 and 3 the conditions laid down in the annex.
17. the summary is part of the documentation, registration of which the applicant providing a gum with the registration application shall be submitted to the State Agency of medicines.
18. The applicant does not submit the safety and residue tests or of clinical and clinical research results if he proves that the veterinary medicinal product to be registered is a generic medicinal product, the reference medicinal product in accordance with the rules of success in Latvia and other European economic area countries are registered for not less than eight years.
19. The provisions referred to in paragraph 18 of the veterinary medicinal product is not placed on the market until the expiration of 10 years after the medicinal product of reference the original issue of the registration certificate.
20. paragraph 18 of these rules also apply if the applicant has submitted to the national agency of medicines of the registration application in respect of the medicinal product, riskaj genitals but the reference medicine in Latvia has not issued a certificate of registration. In this case, the applicant shall indicate the application of the European economic area in which the reference medicinal product is or has been registered. The State Agency of medicines: 20.1. Requests the European economic area in which the reference medicinal product is or has been registered, the competent authority of the month give you certify that the reference medicinal product is or has been registered in the country, as well as information about the full composition of the reference medicinal product and, if necessary, other appropriate documents;
20.2. the other members of the European economic area, the competent authority of the country in which the application for the registration of veterinary medicinal products, the application shall within one month send to the confirmation that the reference medicinal product is or has been registered in Latvia, registered and other documents requested.
21. Veterinary medicinal products for fish, bees or other species of animals laid down in the decision of the European Commission, this provision set out in point 19 10 year period may be extended to up to 13 years.
22. The applicant shall submit to the State Agency of medicines safety and residues testing the substance, not clinical or clinical trial results for a generic medicinal product if: 22.1.uz of the veterinary medicinal product under the provisions referred to in paragraph 2.2 below generic definition;
22.2. bioavailability studies can prove bioequivalence to the reference product;
22.3.ir active substances therapeutic indications, strength, pharmaceutical form or route of administration of the differences with respect to the reference product.
23. where a biological veterinary medicinal product which is similar to a reference biological medicinal product does not meet the definition of generic medicinal products referred to in the off-cījum (in particular – a biological veterinary medicinal product and the reference biological medicinal raw materials or differences in the manufacturing process), the application was submitted without the cold had clinical or clinical research results related to these conditions. Submit additional data types and quantity conform to these rules 2 and 3 of the conditions laid down in the annex and paragraph 37 of these regulations the European Commission referred to the criteria laid down in the guidelines. Other references included in the documentation of the medicinal product research and test results to the applicant is not entitled to submit.
24. Veterinary medicinal products intended for one or more species of animals and vajiem content in active substance which are registered in the community until 2004, 30 April, 23 of these rules referred to in point 10 years the State Agency of medicines shall be extended by one year for each of the registration certificate of the US prices for Ext. other food-producing animal species where such extensions shall be approved within five years from the initial registration certificate.
25. A veterinary medicinal product for four or more food-producing species, 24 of these regulations during the period referred to in paragraph did not give over 13 years.
26. Veterinary medicinal products intended for food-producing animals in the EU's extension to the period 11, 12 or 13 years if granted by the holder of the certificate of Reg. trācij (owner) in accordance with Regulation No 2377/90 is initially submitted the application to the European Medicines Agency the maximum allowable drug residues, which provides for the animal species listed in the registration certificate.
27. Research and testing, as well as the practical requirements that apply to community response to these rules 18, 19, 20, 21, 22, 23 and 24, are not considered as contrary to patent rights or of veterinary medicinal products, supplementary protection certificates.

28. The applicant does not submit the safety and residue tests or of clinical and clinical research results if he proves that the composition of veterinary medicinal products, active substances within the European economic area countries apply the composition of veterinary medicinal products registered for not less than 10 years, medicine has recognized the efficiency and reliability of the level permitted under this provision in annex 2 (for non imunoloģiskaj veterinary medicinal products) or in annex 3 (in relation to imunoloģiskaj veterinary medicinal products). The applicant specifies the use of the scientific literature.
29. As this provision referred to in paragraph 28 of the scientific literature (in particular, of the veterinary drug safety check) the applicant can use evaluate you report by the European Medicines Agency published on application for the evaluation of medicinal products, maximum residue levels in accordance with Regulation No 2377/90.30. If the applicant uses the scientific literature to obtain a certificate of registration in the case of veterinary medicinal products intended for food-producing animals, and to extend the registration certificate (to be able to use this medicine for other food-producing animal species) by the applicant under Regulation No 2377/90 provided for residues of the veterinary medicinal product studies with additional clinical studies. These third parties and their results at a must not be used three years from the date of the registration certificate, in connection with these studies.
31. In the case of veterinary medicinal products containing active substances used in veterinary medicinal products registered in composition, but so far not used the same composition of the veterinary medicinal product for therapeutic purposes, for active substances submitted to clinical and clinical research results and, if necessary, safety and residue tests.
32. with regard to the rules referred to in paragraph 31 of the veterinary medicinal product is presented, the scientific references relating to each individual active substance.
33. After receipt of the registration certificate, the holder of the registration certificate (the owner) is entitled to use of the pharmaceutical, safety and residues, non-clinical and clinical documentation contained in veterinary medicinal products registered in the paper to examine the tation! later application for the registration of veterinary medicinal products having the same qualitative and quantitative composition in active substances and pharmaceutical form.
34. The immunological veterinary medicinal product registration application, the applicant may, in exceptional circumstances, not to submit the results of the field trials carried out in the target species (animal species for which the medicinal product is intended), if you don't investigate the following can make explicit justified reasons and according to the other instruments of the European Union.
35. The veterinary medicinal product, the description shall contain the following information (in the order listed): 21.8. name of the veterinary medicinal product, plus an indication of the strength and the pharmaceutical form;
UR35.2.akt array of substances and adjuvants of qualitative and quantitative composition, which is essential for proper administration of the medicinal product in animals (used widely used or chemical nosa Kuma);
35.3. pharmaceutical form;
35.4. clinical data: 35.4.1. target species;
35.4.2. medicinal indications for use, specifying the target species;
35.4.3. contraindications;
35.4.4. adverse reactions (frequency and severity);
35.4.5. Special precautions for each target species,
35.4.6. use precautionary measures, including special precautions the person who entered the Hall to the animal;
35.4.7. the use of veterinary medicinal products during pregnancy, lactation or lay eggs;
35.4.8. the veterinary medicinal product, interaction with other medicinal products and other forms of mijiedar Beebe;
35.4.9. the veterinary medicinal product, enter the quantity (dose) and the route of administration;
35.4.10. the symptoms and behaviour medicine in case of an overdose (first aid, antidotes);
35.4.11. the withdrawal period, foodstuffs of animal origin, including products for which the withdrawal period is defined is zero;
22.1. pharmacological properties: 35.5.1. pharmacodynamic properties;
35.5.2. pharmacokinetic particulars;
35.6. pharmaceutical particulars: UR35.6.1.pal īgviel;
35.6.2. major drug incompatibility;
35.6.3. period of validity of the medicinal product and a statement of validity for the medicinal product after dilution or primary packaging is opened;
35.6.4. special instructions for the storage of the medicinal product;
35.6.5. the primary form of packaging and contents.
35.6.6. Special precautions for the disposal of unused medicinal products or waste materials, if any;
UR35.7.re ģistrācij card holder (owner) (first name, last name, or name and address or registered place of business);
UR35.8.re ģistrācij card number or certificate number;
22.3. the date originally issued or transferred the registration certificate;
35.10. date specified in the text of the summary of product characteristics.
36. upon the registration of veterinary medicinal products in accordance with these rules 18, 19, 20, 21, 22, 23, 24, 25, 26 and 27, need not specify reference parts of the summary of product characteristics referring to indications or dosage, to which the generic trade during the late subject to patent law.
37. The applicant shall prepare the documentation attached to the application for registration pursuant to this provision: 37.1.10, 11, 12, 13, 14, 15, 16, 17, 18, 19, 20, 21, 22, 23, 24, 25, 26, 27, 28, 29, 30, 31, 32, 33, 34 and 35, as well as in paragraph 2., and 3. the requirements referred to in the annex;
37.2. The pharmaceutical law referred to in article 28.1, the European Commission's recommendations, contained in the notification of the application to the applicant for marketing authorisation for veterinary medicinal products in the Member States of the European Union, the European Commission published the European Union regulatory framework for medicinal products document item At in "veterinary medicine";
37.3. The European Commission's guidelines on the quality, safety and efficacy of the veterinary medicinal product, which is published by the European Commission European Community legal framework document of the medicinal product in stock;

23.2. the conditions that have submitted information on the evaluation of veterinary medicinal products to be registered (irrespective of whether the assessment is favourable or unfavourable). The applicant shall submit to the State Agency of medicines shall also the information about the tests of veterinary medicinal products or research that is not complete or not complete. After receipt of the registration certificate, the holder of the registration certificate (nothing special) the State Agency of medicines shall, without delay, provide any information that is not included in the original registration documentation and apply to the benefit and risk assessment (veterinary medicinal products, the positive therapeutic effect evaluation in relation to certain risks);
37.5. the condition that animal testing is carried out in accordance with the relevant provisions of the rules for experiments and scientific purposes of animals used, use, trade and the killing.
III. Procedures for registered homeopathic veterinary medicinal products 38. This chapter shall not apply to the homeopathic veterinary companies imunoloģiskaj medicines.
39. the State Agency of medicines: 24.3. homeopathic veterinary medicinal products which are manufactured and distributed in Latvia, registered in accordance with the requirements of this regulation;
24.4. homeopathic veterinary medicinal products which satisfy the provisions of paragraph 40:39.2.1. establish a simplified registration procedure;
39.2.2. This 73, 74, 75, 76, 78, 77, 79, 80 and 81.
40. the State Agency of medicines shall apply to the simplified registration procedure for the homeopathic veterinary medicinal products that: 24.9. route of Administration comply with the monographs of the European Pharmacopoeia or, failing this, of the European economic area-use the official pharmacopoeia Mono grāfij;
ķējum and UR40.2.mar in the instructions for use or in one of the documents submitted for registration does not specify specific therapeutic indications;
UR40.3.at is a sufficient degree of dilution to guarantee the safety of the medicinal product. Medicinal product shall not contain more than one part in 10000 of the mother tincture (basic tincture).
41. the registration of homeopathic veterinary medicinal products, the State Agency of medicines of sific its her prescription or non-prescription (medications that are permitted to distribute without a prescription) medicinal products.
42. The rules referred to in paragraph 40 of homeopathic veterinary medicinal products the simplified registration procedure shall use the criteria and conditions under this provision the requirements contained in chapter IV. Do not apply these rules 51, 52, 53, 54 and 55 of the requirements referred to in paragraph and drug therapeutic effect supporting documentation requirements.
43. The applicant who registered homeopathic veterinary medicinal products, applying the simplified registration procedure, the State Agency of medicines shall be submitted in the registration application. Simplified application for registration may include a homeopathic veterinary medicinal product derived from one and the same international inputs on homeop (output). Homeopathic veterinary medicinal product registration the applicant providing a gum to homeopathic veterinary medicinal product quality and homogeneity produced the series (a series of identity of medicinal products), the application for registration shall be accompanied by: 43.1. document describing the homeopathic stock or scientific name, or the name specified in the Pharmacopoeia, together with a description of the drug administration, pharmaceutical forms and degree of dilution;
43.2. Description of the homeopathic stock or stocks is/are obtained, control and their homeopathic exposure, using the appropriate bibliography. If the tisk homeop veterinary medicinal product contains organic substances, a description of the measures taken to provide the medicines against pathogenic organisms;
43.3. the document for each pharmaceutical form of manufacture and controls;
UR43.4.at dilution and potencēšan methods;
43.5. special permission (license) homeopathic veterinary medicinal product concerned;
UR43.6.cit s European economic area countries issued the copy of the registration circle gray issued the same homeopathic veterinary medicinal products;
27.2. one or more homeopathic veterinary medicinal products to be registered for the primary and secondary packaging samples or their advertising samples;
27.2. documents certifying the stability of homeopathic veterinary medicinal products;
43.9. the recommended withdrawal period and the grounds for determining it.
44. a simplified registration procedure shall not apply to the homeopathic vets» rināraj medicinal products which are not listed in this provision in paragraph 40 (for the treatment of food-producing animals). Certificate of registration procedure for those homeopathic veterinary medicinal product is appropriate for these rules 10, 11, 12, 13, 14, 15, 16, 17, 18, 19, 20, 21, 22, 23, 24, 25, 26, 27, 28, 29, 30, 31, 32, 33, 34, 35, 36 and 37 points in those requirements.
45. the State Agency of medicines has the right to apply exceptions to the inspection and safety of clinical and non-clinical studies, homeopathic veterinary medicinal products intended for use in the home (the room) and non-food-producing animals exotic animals in accordance with the principles of homeopathy in practice and their characteristics. In this case, the State Agency of medicines shall notify the European Commission of the applicable exemptions.
IV. Procedures for submission and consideration of registration to be issued a certificate of registration of veterinary medicinal products medicinal products 46 national agency for veterinary medicinal products shall be issued a registration certificate for 210 days from the date of receipt by such terms presented in the registration submission. Registration submissions than one submitted to the veterinary medicinal product in two or more European economic area countries, dealt with in accordance with this provision the requirements of chapter V.
47. the State Agency of medicines has the right to terminate the registration of the application, look for the rolling, if the registration application and the documentation is already covered in another European economic area country. In this case, the State Agency of medicines shall inform the applicant that it applies this provision in chapter V.
48. If a State Agency of medicines in accordance with the provisions of paragraph 13.4.1. receives information that a European economic area country has received the certificate of registration of veterinary medicinal products for which the State Agency of medicines of the registration application, the State Agency of medicines shall reject the application for registration, unless it is filed under this provision the requirements of chapter V.

49. the State Agency of medicines shall consider the registration application, submitted in accordance with the provisions of 10, 11, 12, 13, 14, 15, 16, 17, 18, 19, 20, 21, 22, 23, 24, 25, 26, 27, 28, 29, 30, 31, 32, 33 and 34 requirements referred to in paragraph 1, and: 30.5. verify the information specified in the registration application to the common documents;
49.2.ir may be sent to the veterinary medicinal product, its starting materials and, if not difficult, intermediate products or other medicine ingredients, laboratory investigation of medicinal products in a laboratory of the Agency of State or other laboratory, entitled control medicines, to verify that the submitted documents for registration of medicinal products medicinal products specified by the manufacturer control techniques are sufficient for the quality control of veterinary medicinal products;
30.6. require the applicant to provide additional information, if the information supplied is incomplete. This provision, paragraph 46, the registration period shall be extended until the State Agency of medicines submitted the requested documents or proposals, if necessary, the applicant provided a verbal or written explanation to the questions the Board resulting from the examination of the submitted documents for registration;
49.4.ir may require that the applicant, in the service of food and rajā presented at the veterin necessary substances in quantities needed to test the analytical methods given their determination for residues of veterinary medicinal products, the applicant again providing a specified by the registration documents.
50. the State Agency of medicines: 50.1. check that the manufacturer of the veterinary medicinal product is able to produce veterinary medicinal products in accordance with the information submitted in accordance with the provisions of section 13.4, and perform quality control of veterinary medicinal products by the methods specified in the documents submitted for registration in accordance with the provisions of section. 1.4. If in certain justified cases, the manufacturer of the veterinary medicinal product for veterinary use certain stages of production or quality control of veterinary medicinal products, a third party, the State Agency of medicines has the right to carry out the undertaking concerned;
50.2. testing of the veterinary medicinal product or the importer from a third country is able to perform quality control of veterinary medicinal products by the methods specified in the documents submitted for registration in accordance with the provisions of section. 1.4. If in certain justified cases, for importing of veterinary medicinal products from third countries to the mermaid medicinal veter quality control executed by a third party, the State Agency of medicines has the right to carry out the undertaking concerned;
50.3. the examination of the third countries compliance with veterinary medicinal products produced by these rules, the point of 50.1 Kuma. taken into account the arrangements laid down in the European Commission's summary of Community inspection and information exchange procedures.
51. the State Agency of medicines shall be issued a certificate of registration and approved summary of product characteristics. On the summary of the product characteristics as approved by the State Agency of medicines shall inform the holder of information in the register (the owner).
52. the State Agency of medicines shall ensure that information on veterinary medicinal products (in particular, drug labelling and package leaflet) with the summary of product characteristics of the medicinal products which have been approved by the State agency with a certificate of registration or thereafter.
53. the State Agency of medicines shall immediately provide the registered veterinary drug registration certificate and summary of publicly available national tour of the medicinal agent website online.
54. the State Agency of medicines shall prepare an assessment report on the veterinary medicinal product, including comments on documents submitted for registration (including veterinary medicinal products, the safety and pharmacological tests for residues and non-clinical and clinical studies). The assessment of the veterinary medicinal product notifies you of updated information on the veterinary drug quality, safety and efficacy, as soon as it becomes available.
55. the State Agency of medicines shall be removed from this provision in paragraph 54 that the evaluation report of the veterinary medicinal product is commercially confidential and available to the public the text of the message for the rest of the medicines agency website on the internet.
56. the State Agency of medicines has the right to require that the holder of the registration certificate (the owner) on the primary or the secondary packaging and the use of instruk tion indicates information about the precautions for the use of the medicinal product, animal, or other human or animal health or unsafe in bai necessary information which has become known by the pharmacological tests or the results of clinical trials of medicinal products for veterinary use or practice.
57. In exceptional cases, for objective and verifiable reasons medicine State Agency after consultation with the principal applicant is entitled to take a decision on the registration of veterinary medicinal products if the applicant fulfils certain requirements (in particular concerning the safety of the medicinal product), as well as the starpg announces the game in connection with the veterinary use of green and the measures taken. Registration certificate remains valid if the State Agency of medicines each year to re-evaluate requirements.
58. After receipt of the registration certificate holder (owner), in the light of scientific and technical progress, the complement of the veterinary medicinal product control methods to veterinary medicinal products to be manufactured and tested according to the generally accepted to know Latin. About the changes, inform the State Agency of medicines. The State Agency of medicines shall examine and approve the changes.
59. the holder of the registration certificate (the owner) by the food and veterinary service request: 59.1. provide enough of the substance to be able to make the determination for residues of veterinary medicinal products according to the rules for the determination of residues of medicines and its financing arrangements;
59.2. based on your experience, provide technical advice, in order to facilitate the determination of residues of the veterinary medicinal product analysis methods in the food and veterinary service national diagnostic Center.
60. The holder of the registration certificate (the owner) to immediately inform the State Agency of medicines, if the information is available: 60.1. which complement the message or document designed for that rule 13, 18, 19, 20, 21, 22, 23, 24, 25, 26, 27, 28, 29, 30, 31, 32, 35, 36 and 37 points or 2 and 3 of these regulations the requirements contained in the annex;
UR60.2.par competent authorities for restrictions or prohibition of tions in respect of veterinary medicinal products in each country in which the veterinary medicinal product is placed on the trade;

UR60.3.kas can affect that veterinary medicinal product, the risk-benefit relationship. To continue the risk-benefit relationship, the State Agency of medicines has the right to require that the holder of the registration certificate (owner) information demonstrating that the risk-benefit balance remains favourable.
61. the holder of the registration certificate (the owner) to immediately inform the State Agency of medicines, if necessary, amendments to these regulations 10, 11, 12, 13, 14, 15, 16, 17, 18, 19, 20, 21, 22, 23, 24, 25, 26, 27, 28, 29, 30, 31, 32, 33 and 34. veterinary medicinal products referred to in paragraph registration documentation or registration certificate.
62. After receipt of the registration certificate holder (owner) shall inform the National Agency for medicines: 62.1. day when the registered veterinary medicinal products placed on the market, taking into account the registered pharmaceutical form;
62.2. period stopped placing the veterinary medicinal product on the market or veterinary medicinal products from the market. The information that the holder of the registration certificate (the owner) shall notify not later than two months prior to the date you stopped placing the veterinary medicinal product on the market, except in exceptional circumstances.
63. at the request of the State Agency of medicines of the holder of the registration certificate (the owner) on the use of veterinary medicinal products pharmacovigilance system promoted super-power indicates all data on the volume of sales of the veterinary medicinal product and the disposal of their existing data on prescriptions prescription volume.
64. The registration certificate shall be valid for five years.
65. A certificate of registration re-register after five years on the basis of the risk-benefit ratio of recurrent evaluation. The holder of the registration certificate (the owner) the State Agency of medicines shall be submitted in the application and then added to the consolidated list of documents submitted for the veterinary medicinal product, the quality, safety and efficacy, and all amendments introduced since the original registration certificates issued by ING. The holder of the registration certificate (the owner) and the consolidated list of the application submitted to the State Agency of medicines not later than six months before the registration certificate expires. The State Agency of medicines shall be entitled at any time to require the holder of the registration certificate (the owner) shall submit the documents specified in the list, to clarify the information submitted.
66. after the renewal of the certificate of registration in accordance with the provisions of paragraph 65 is valid for unlimited time (except when the State Agency of medicines based on the use of veterinary medicinal products in the pharmacovigilance system, down one additional renewal after five years in accordance with the provisions of paragraph 65).
67. The registration certificate shall be considered invalid if the veterinary medicinal product within three years after the decision of the veterinary medicinal products concerned on the date of registration is not placed on the market.
68. The registration certificate shall be deemed invalid if, after the registration of veterinary medicinal products, they are placed on the market, but after three years in a row are not sold.
69. the national agency of medicinal products, taking into account the exceptional circumstances and human or animal health shall have the right to make exceptions to this rule 66 and 67 above conditions. Such derogations shall be suitably substantiated.
70. the issue of the registration certificate does not relieve the manufacturer of the veterinary medicinal product and the holder of the registration certificate (the owner's) responsibility.
71. the State Agency of medicines of the registration certificate shall not be issued if: 71.1. when considering the registration of veterinary medicinal products, the documents submitted, it is established that the documents submitted for registration does not comply with these rules 10, 11, 12, 13, 14, 15, 16, 17, 18, 19, 20, 21, 22, 23, 24, 25, 26, 27, 28, 29, 30, 31, 32, 33 and 34 of these requirements.
71.2. after registration documents and data submitted, it is established that: 71.2.1. the veterinary medicinal product, the risk-benefit ratio, they are using the information in the registry as specified in the documents, is negative (in particular – in the context of assessing the benefits to animal health and welfare and to consumer safety relating to veterinary medicinal products used for zootechnical purposes);
71.2.2. in the case of veterinary medicinal products not specified in the registration dossier or therapeutic effect the applicant has not provided sufficient proof of such effect registration documents specified in the target species of animal;
71.2.3. the veterinary medicinal product, qualitative and quantitative composition is not the registration documents;
71.2.4. applications the recommended withdrawal period for veterinary medicinal products: UR71.2.4.1.nav long enough to ensure that derived from animals treated food products of animal origin do not contain residues of veterinary medicinal products for the health of the consumer in dangerous quantities;
UR71.2.4.2.nav reasonable enough;
71.2.5. the applicant's proposed labelling of the veterinary medicinal product or the package leaflet do not comply with the requirements of the veterinary medicinal products shall be marked with confirmatory, distribution and control;
71.2.6. the use of veterinary medicinal products is prohibited in the European Union.
72. The applicant or holder of the registration shall be responsible for the accuracy of the data submitted.
V. procedures for veterinary medicinal products registered via the mutual recognition procedure and decentralised procedure 73. to medications registered in more than one country of the European economic area (hereinafter referred to as the participating Member States), the principal applicant of each participating Member State by the competent authority (Latvia-National Agency for medicinal products) shall submit an application for the registration of veterinary medicinal products shall comply with the following: 73.1. registration of veterinary medicinal products shall contain the administrative information and scientific and technical information requirements referred to these rules 10, 11, 12, 13, 18, 19, 20, 21, 22, 23, 24, 25, 26, 27, 28, 29, 30, 31, 32, 35, 36 and 37;
73.2. registration dossiers submitted to the uniform throughout the participating Member States;
UR73.3.re ģistrācij for documentation added to the list of participating Member States, which submitted the registration application.
74. If participating Member States veterinary drug submission at the time of registration: 74.1.ir registered veterinary drug register mutual recognition procedure;
74.2. is in the process of registration of veterinary medicinal products to be registered in the decentralised procedure.

75. before the submission of the application for the registration of veterinary medicinal products, use the repeated mutual recognition procedure, the applicant is requesting a Member State concerned, for it is the reference Member State shall prepare the veterinary medicinal product and the assessment report. If the reference Member State Latvia, State Agency of medicines shall prepare an assessment report on the veterinary medicinal product or renew the evaluation report of the administrative procedure law, but not more than 90 days after the submission of the registration requirements. If necessary, the State Agency of medicines the assessment report shall contain an evaluation according to this provision, 26, 27 and 28 the requirements referred to in paragraph or in paragraph 32. The evaluation report by an approved veterinary summary of product characteristics, labelling and package leaflet of the medicinal product, a government agency sends the application to the applicant and the Member States concerned.
76. If the application for registration to the date of the registration certificate in another participating Member State is not issued and Latvia is a country of reference membership the applicant requires the State Agency of medicines shall prepare a monitoring report and resultant estimates of the veterinary medicinal product characteristics, labelling and package leaflet. The State Agency of medicines shall prepare such projects in the tratīv process of Admin law, but not more than 120 days after the application for registration of a valid receipt and send it to the membership for the countries concerned and the applicant.
77. the National Agency for medicinal products within 90 days of the 75 or 76. these provisions referred to in paragraph draft assessment report and the summary of product characteristics, labelling and package leaflet of the receipt of the draft: 77.1. approved documents and shall inform the reference country, Latvia's membership if the Member States involved;
77.2. following receipt of the information from the Member States concerned shall record the agreement of the participating Member States, close the procedure and shall immediately inform the principal applicant, if Latvia is the reference Member State.
78. If a State Agency of medicines of the submitted application for the registration of veterinary medicinal products in accordance with this paragraph 73, the State Agency of medicines: UR78.1.pie takes the decision according to the approved assessment report, summary of product characteristics, labelling and package leaflet to the administrative procedure law, but not later than 30 days after this provision 77.2. referred to in the approval of the arrangement;
UR78.2.par the decision taken shall inform the reference Member State, the application for registration of the applicant and the other Member States concerned.
79. If a State Agency for medicinal products, on the basis that registerable veter in mermaid grass may pose risk to human or animal health or the environment, 90dien not approve the assessment report, summary of product characteristics, labelling and package leaflet of the medicinal product, the State Agency shall provide detailed justification: 79.1. the observations the applicant, the reference Member State and the participating Member States;
UR79.2.par questions, which is not agreed, shall immediately inform the coordination group, established the European Medicines Agency to examine all issues related to the registration of the medicinal product in two or more countries of the European economic area (hereinafter referred to as the coordination group). The Secretariat of the coordination group of the European Medicines Agency.
80. in order to justify the refusal to issue a registration of the immunological veterinary medicinal product certificate of the decentralised procedure, the State Agency of medicines has the right to impose conditions on the prohibition to distribute immunological veterinary medicinal products laid down in legislation on the labelling of the veterinary medicinal product, distribution, and control rules.
81. the State Agency of medicines of 60dien after this rule 79.2. apakšpun JTIS in receipt of that information to provide the applicant an opportunity to provide oral or written explanations.
82. If the participating Member States on the questions which are not agreed fucking, 60 days of notification by the coordination group: 82.1. agree: 82.1.1. and Latvia is the reference Member State, the State Agency of medicines shall record the agreement, close the procedure and inform the applicant of the application;
82.1.2. and Latvia is a participating Member State, the State Agency of medicines shall decide according to the rules of procedure referred to in paragraph 78;
82.2. agree and Latvia is the reference Member State, the State Agency of medicines shall, without delay, submit to the European Medicines Agency, a detailed description of the facts of the matter on which no agreement was reached, and the reasons for the dispute. This document, send a copy to the applicant.
83. as soon as the applicant has been informed of the agreement and not received this rule 82.2. the document referred to in the copy of the application, the applicant shall immediately forward the European Medicines Agency in paragraph 73 of the said information and copies of documents.
84. If the State Agency of medicines has received two or more specific applications for registration of veterinary medicinal products in accordance with the provisions of 10, 11, 12, 13, 18, 19, 20, 21, 22, 23, 24, 25, 26, 27, 28, 29, 30, 31, 32, 35, 36 and 37 of the order referred to in paragraph 1 and other European economic area countries have made different decisions fly in relation to the registration of veterinary medicinal products the information in the registry, licence suspension or cancellation, medicine, a government agency, the European Commission or the holder of the registration certificate (the owner) is entitled to apply to the Committee for veterinary medicinal products (hereinafter referred to as the Committee) to identify the problem and submit any information in its possession.
85. the State Agency of medicines of the European Medicines Agency and the European Commission decision of the 22 days of the dispute may send a written opinion on the European Commission's draft decision. The State Agency of medicines has the right to submit a written request to draft decision discussed in Committee. If the opinion of the European Commission, the State Agency of medicines of the written opinion caused new important scientific and technological nature, which have not been addressed, document discussion and consideration of the European Medicines Agency will continue.

86. the national agency of medicinal products and the competent authority of the reference Member State shall decide on the registration of veterinary medicinal products, or withdrawal of the certificate of registration, or the need to amend the registration documentation to comply with the European Commission's decision within 30 days of notification of the decision of the European Commission. The State Agency of medicines of the decision taken shall inform the European Commission and the European Medicines Agency.
87. The holder of the registration certificate (the owner) that is registered by the veterinary medicinal product, the mutual-recognition procedure or the decentralised procedure, any amendments (changes) the registration certificate of the veterinary medicinal product which has been granted in accordance with the requirements referred to in this chapter shall be submitted to all the countries of the European economic area in which the veterinary medicinal product registered.
88. If a State Agency of medicines of human and animal health and the protection of nature, it is considered that: 88.1.ir the amendments required in the registration certificate issued in accordance with the requirements of this chapter, or that the registration certificate is required to suspend or revoke, it will immediately turn to the European Medicines Agency, identifies the problem and submit all the relevant information;
88.2.ir urgent action to protect human life or health or the environment, Bosh, State Agency of medicines of Latvia is entitled to suspend, in accordance with the requirements referred to in this chapter, the register of tion of the veterinary medicinal product certificate. The State Agency of medicines shall, not later than the next working day shall inform the reasons for its action the European Commission and other European ' chemical zone of countries that have established that the veterinary medicinal product.
89. This rule 81, 82, 83, 84, 85 and 86.. the requirements referred to in paragraph do not apply these rules referred to in paragraph 40 of homeopathic veterinary medicinal products.
90. This 73, 74, 75, 76, 78, 77, 79, 80, 81, 82, 83, 84 and 85. proceedings of the type referred to in paragraph 1 shall not apply the provisions referred to in paragraph 45 of homeopathic veterinary medicinal products.
Vi. in clinical trials of veterinary medicinal products and the use of observation 91. If the applicant for clinical trials of the veterinary medicinal product and the use of observations carried out in the Republic of Latvia, it must receive the food and veterinary service.
92. The applicant provides the veterinary medicinal product, and clinical trial observation of the conduct of the use according to paragraph 37 of these regulations, as well as in annex 2 and 3.
93. clinical trials of the veterinary medicinal product by the use of observations and findings the applicant sent to the State Agency of medicines. The data is sufficient to provide a scientific opinion on the compliance of veterinary medicinal products, the registration of veterinary medicinal products.
VII. Changes to registration of veterinary medicinal products and the extension of the registration dossier 94. To confirm the change of registration dossiers of the veterinary medicinal product, the holder of the registration certificate (owner) submits an application for the approval of the change. The application shall be accompanied by the particulars and documents which comply with the European Commission published the specimen and were prepared in accordance with the requirements laid down in these rules of registration dossiers. The said application shall be submitted to the Parliament and the doc: 94.1. Medicine National Agency for veterinary medicinal products established in the national registration procedure, which is not recorded in the mutual recognition procedure or the decentralised procedure;
94.2. the national agency of medicinal products and the European economic area, the competent authorities in accordance with the European Commission of 3 June 2003, Regulation (EC) no 1084/2003 concerning the examination of variations to marketing authorisations in the nosacīj mo, granted by a competent authority of a Member State to the people about the finance and veterinary medicinal product if the product is registered in the mutual recognition procedure or the decentralised procedure;
58.6. European Medicines Agency under Commission of 3 June 2003, Commission Regulation (EC) No 1085/2003 concerning the examination of variations of a marketing authorisation for medicinal products for human use and veterinary medicinal products conditions, within the scope of Council Regulation (EEC) No 2309/93, if the product is registered in a centralized registration procedure.
95. the State Agency of medicines according to the competency rule 94.3. meet this bottom point referred to in the regulation to the competent supervisory authorities.
96. for the decision on the registration of veterinary medicinal products, the expansion of the national registration of medicinal products established in the procedure (which are not recorded in the mutual recognition procedure or the decentralised procedure), the holder of the registration certificate (the owner) the State Agency of medicines shall be submitted in the application under the European Commission published the sample, which is published by the national agency of Medicine home page on the internet (which includes data and are specified in the attached documents).
97. as regards the procedure of registration in the national register of medicinal products in the raj veterin (which are not recorded in the mutual recognition procedure or the decentralised procedure) the State Agency of medicines: take a decision on the UR97.1.pie of the veterinary medicinal product registration extension, if any particulars or documents submitted in compliance with this provision confirms 5. criteria referred to in the annex. In this case, the name of the veterinary medicinal product meets the mermaid medicinal nosa veter Kuma specified in the original registration decision;
97.2. in accordance with the provisions of Chapter VIII or IX examine the tubers of runny submitted change approval and shall take a decision on the approval or non-approval of the change.
VIII. the IA and type IB registration of veterinary medicinal products 98. registration procedure established in national veterinary medicinal products (which are not recorded in the mutual recognition procedure or the decentralised procedure) small type I (type IA and type IB) changes in the registration dossier is referred to the provisions of annex 6. This change in assessed and approved in accordance with this chapter.
99. The provisions referred to in paragraph 98 of the veterinary medicinal product: 99.1. application of small type I variations indicate only one type I changes;
99.2. submissions, one showing the connection between all resulting changes, if submitted: 99.2.1.no one variations of type IA, clear one or more of the other type IA;
99.2.2.no single variations of type IB follows type IA or type IB;
If several be 99.3. Type I variation each change submitted a separate application. Each application contains a reference to the other submissions, if any;

If 99.4. Type I variations shows that the summary of product characteristics, labelling or the instructions for use should be amended, it is regarded as part of the change.
100. the State Agency of medicines shall examine the conformity of the application of these rules 98 and 99. the conditions referred to in points, evaluate the submitted data and doc file (document inspection) and the Act on administrative procedures in accordance with the procedure laid down in the decision on the approval of changes in registration or approval of the change, noting that data and document evaluation (inspection) is performed: 100.1. minor variations of type IA-14dien after the application receives the State Agency of medicines;
100.2. minor variations of type IB-30dien after the application receives the State Agency of medicines.
101. the State Agency of medicines has the right to require that the holder of the registration certificate (the owner) provides additional information. In such a case, the rules of procedure referred to in paragraph 100 suspending until the date on which the holder of the registration certificate (the holder) shall submit to the State Agency of medicines of the requested additional information.
102. If, after the application for the change of the type IB and its attached data document and other information for the evaluation of medicinal products the State Agency considers that the application is admissible, the State Agency of medicines of the administrative procedure law, but not more than 30 days after this note to KUMU in paragraph 98 of the receipt of the application, provide the registration certificate holder (owner) a reasoned opinion. The holder of the registration certificate (the owner) is entitled to 30 days of the State Agency of medicines shall obtain the opinion of amendment of type IB variation application, subject to the opinion of the State Agency of medicines in that basis. If the holder of the registration certificate (nothing special) make such amendments in the application for the change of type IB, it said 30dien in writing, notify the State Agency of medicines of the amendments.
103. If the holder of the registration certificate (owner) in the application for the change type IB shall be amended in accordance with the provisions referred to in paragraph 73 of the conditions, the application shall be deemed to have been rejected, and the State Agency of medicines of the decisions on the approval of the change, notify the holder of the registration certificate (owner) of the administrative procedure law, but not more than 30 days.
104. If a State Agency of medicines is not notified of the registration certificate kept in the jam (the owner) the decision on approval of the change under this provision, paragraph 102 procedure is considered that a government agency has approved the changes and the holder of the registration certificate (the owner) may introduce changes.
IX. Important changes of type II registration documentation and registration holder (owner) company or address change 105. registered in the national registration of veterinary medicinal products (which are not recorded in the mutual recognition procedure or the decentralised procedure) important-type II changes – changes that: this does not match rules 105.1.5 and 6 of the annex;
105.2.ir related to the registration holder (owner) of the firm (the holder of the registration certificate (the owner) and the new information in the registry holder (owner) are one and the same person) or change of address.
106.105. These provisions referred to veterinary medicinal products: 106.1. application for type II changes only one type II except where: one UR106.1.1.par medicinal products be made more changes of type II. In this case, for each change submitted application and each application is a reference to all the rest of the submissions, if any;
106.1.2.no single variations of type II follows other changes. For all these changes you can submit one application, and it indicates a relationship between all resulting changes;
106.2. If the changes follows that of the veterinary medicinal product, the description on the labelling or the package leaflet should be amended, it is regarded as part of the change.
107. the State Agency of medicines shall examine the conformity of the application of this provision in paragraph 105 and 106 said conditions, evaluate the submitted data and documents (document inspection) and the Act on administrative procedures in accordance with the procedure laid down in the decision on the approval of the change in the registration dossier. Data and documents to be assessed (expertise): 107.1.ne for more than 60 days after receipt of the application to the State Agency of medicines. That time limit may be reduced, if the matter is urgent (especially in relation to security issues);
107.2.ne longer than 90 days after receipt of the application to the State Agency of medicines, if the application is associated with therapeutic indications or in LaTeX information replenishment.
108. the State Agency of medicines has the right to require that the holder of the registration certificate (the owner) provides additional information. In such a case, the rules of procedure referred to in paragraph 107 of the suspension to the date on which the holder of the registration certificate (the holder) shall submit to the State Agency of medicines of the requested additional information.
109. in the registration procedure established in National veterinary medicinal products (which are not recorded in the mutual recognition procedure or the decentralised procedure) holder of the registration certificate (the owner's) name and legal address change in the case of the holder of the registration certificate (the owner) the State Agency of medicines shall be submitted in the application, if the holder of the registration certificate (the owner) is not the same person. The application shall be accompanied by the following documents and specify the following information: 109.1. document confirming the registration holder (owner);
109.2. name of the veterinary medicinal product, the registration certificate number and date of registration;
UR109.3.eso the holder of the registration certificate (the owner's) name and address of the firm of mu, as well as the name and address of the person that is expected to put the registration certificate;
109.4. document proving the transfer point for the complete and updated documentation for registration of veterinary medicinal product, or its availability and transfer of the copy to the person transferring the registration certificate;
109.5. date when the person that is expected to pass the registration certificate, takes over the duties of the previous registration certificate holder (owner);

109.6. a document showing that the person to whom the certificate of registration of the transfer, the ability to take the holder of the registration certificate (the owner's) obligations under the requirements of the legislation on veterinary medicine and now control the production of veterinary medicine distribution, promotion, unwanted blakuspar in recent years, and clinical trials. That document shall indicate: 109.6.1. person responsible for actions in relation to veterinary medicines side effects monitoring system (personal address, phone and fax number, a brief description of the action and experience);
109.6.2. Services, who is responsible for the promotion of the veterinary medicinal product and distribution (business address, phone and fax numbers);
109.7. Description of veterinary medicinal products, instructions for use and labelling;
109.8. document confirming the payment for the evaluation of medicinal products in accordance with the national agency of public services price list.
110. The date when the certificate of registration will be transferred to the new holder of the registration certificate (owner), the State Agency of medicines shall determine, and record the date of the contract, which closed the existing and the new registration certificate holder (owner). The period of validity of the certificate of registration does not change.
X. closing questions 111. Be declared unenforceable in the Cabinet of 22 April 2004, Regulation No 409 "procedure for registration of veterinary medicinal products" (Latvian journal, 2004, 69, no. 201; 2006, 68 no).
112. The veterinary medicinal product, the registration certificate issued to the mu set to the date of entry into force of those specified are valid until the expiry date.
Informative reference to European Union directives, the regulations include provisions resulting from: 1) of the European Parliament and of the Council of 6 November 2001 of Directive 2001/82/EC on the Community code relating to veterinary medicinal products;
2) of the European Parliament and of the Council of 31 March 2004, Directive 2004/28/EC that the right Directive 2001/82/EC on the Community code relating to veterinary medicinal products.
Prime Minister a. Halloween farming Minister – the Minister of Interior Or. Jaundžeikar Editorial Note: rules shall enter into force on 11 august 2006.
 
The Ministry of Agriculture presented version of annex 1 of the Cabinet of Ministers of 18 July 2006, regulations no 600 farming Minister – the Minister of Interior Or the Ministry of agriculture in Jaundžeikar. submitted in annex 2 to the Cabinet of Ministers of 18 July 2006, regulations no 600 imunoloģiskaj not veterinary medicinal products (I). A summary of the dossier administrative data 1:1.1. medicinal products for veterinary use covered by the registration application shall be identified by name and active substance (s) name showing its strength, pharmaceutical form, route of administration and usage, as well as a description of the final sales presentation;
1.2. the application for registration presented by the applicant, the name and address of the manufacturers, and the sites involved in the different stages of production, including the manufacturer of the finished product and the manufacturer of the active substance and, where applicable, the name and address of the importer;
1.3. the registration applicant shall indicate precisely the number and name of the document which he submitted together with the application, as well as indicate the specimens submitted, if any shall be submitted;
1.4. in the annex to the administrative data shall be accompanied by a document showing that the manufacturer is authorized to produce the veterinary medicinal products concerned, as defined in the law on procedures for the issue, suspend, and revoke the re-registered at the special permission (license) veterinārfarmaceitisk activities (marketing authorization) as well as the countries of the European economic area (hereinafter referred to as Member States) list that is assigned to a registration certificate, copies of all the descriptions of the medicinal product in accordance with this regulation, the requirements of paragraph 35. approved by the Member States, and a list of those Member States in which the application is lodged.
2. Description of the medicinal product: 2.1 the applicant provides a summary of product in accordance with the provisions of paragraph 35;
2.2. the application the applicant shall provide one or more specimens of the veterinary medicinal product or ad mock-ups with the instructions for use of the sample, if you need it.
3. the summary report: 3.1 in accordance with the provisions of article 15, paragraphs 16 and 17 of the requirements presented a summary report of the expert analysis documentation, pharmaceutical residues of toxicological documentation, documentation and the clinical documentation;
3.2. each summary report consists of the various tests and/or trials conducted in accordance with the requirements of these regulations, critical evaluation, and bring out all the data relevant to the assessment. Expert gives an opinion on whether there are sufficient guarantees of the veterinary medicinal products concerned on the quality, safety and efficacy. A summary of the facts is insufficient;
3.3. all important data is collected by an expert summary report, if possible, tables or graphical way. The expert report and the summaries shall contain precise cross references to the information contained in the basic document;
3.4. each expert shall prepare a summary report of a person with the appropriate qualifications and experience. Signed and dated by the expert, and the summary report shall be accompanied by a short news about expert education and professional experience. Reflects expert and the applicant's professional relationship.
II. the immunological veterinary medicinal product Not analytical (physico-chemical, biological or microbiological) tests 4. All test procedures shall correspond to the State of scientific progress at the time and shall be validated procedures, as well as the results of the validation studies shall be provided.
5. All test procedures described in sufficient detail for it to be repeated in control tests, carried out at the request of the State Agency of medicines. Description of the special equipment to be used and the equipment, adding the scheme. The formulae of the laboratory reagents shall be supplemented, if necessary, by the method of preparation. The testing procedures included in the European Pharmacopoeia or in the pharmacopoeia of a Member State, this description may be replaced by a detailed reference to the pharmacopoeia in question.
6. This rule 13.3 States on veterinary medicinal products, active substances constituting the components and the qualitative and quantitative composition shall be submitted in accordance with the following requirements:

6.1. qualitative particulars (medicine "qualitative particulars" of all the constituents themselves that are named and described in the active substance, excipient components regardless of their nature or the quantity used, including colouring matter, preservatives, adjuvants, stabilisers, thickeners, emulsifiers, flavour and aromatic substances URu.tml., the outer covering of the medicinal product (capsules, gelatine capsules URu.tml.) components, intended for ingestion or otherwise enter the animals). These particulars shall be supplemented by any data concerning the container and the type of conclusion, together with data on the use of the medicinal product and input devices, which will be delivered with the medicinal product;
6.2. the "usual terminology", to be used in describing the constituents of medicinal products, apart from this rule 13.3) (General rules, means: 6.2.1. in respect of substances which appear in the European Pharmacopoeia or, if they are not, in the national pharmacopoeia of one of the Member States, the main title of the monograph in question with reference to the pharmacopoeia concerned;
6.2.2. in the case of the other substances – World Health Organisation les recommended international non-proprietary name (Inn), which may be accompanied by another non-proprietary name, or, failing these, the exact scientific designation. Substances not having an international non-proprietary name or an exact scientific designation shall be described by defining how and from what they were prepared, supplemented, where appropriate, with other relevant information;
6.2.3. for colours – "E" designator code, which then allocated according to annex 4 to these regulations;
6.3. the quantitative particulars: 6.3.1. to provide all active substances of the medicinal product ' quantitative particulars ', according to the pharmaceutical form for each active substance mass or units of biological activity of dosage unit or mass, or volume;
6.3.2. the units of biological activity shall be used for substances that cannot be detected chemically. If the World Health Organization an international unit of biological activity has been defined by, then use it. If not defined between folksy unit of biological activity, the units of biological activity shall be expressed in such a way as to provide unambiguous information on the activity of the substances;
6.3.3. If possible, indicate the biological activity per unit of mass or volume. This information adds: 6.3.3.1. in respect of injectable veterinary medicinal products-each vessel active substance in the unit, by the mass or units of biological activity, taking into account the extent of the use of the medicinal product after reconstitution;
6.3.3.2. in respect of the medicinal product, enter the droplets, each active substance mass or units of biological activity, which is the number of drops corresponding to 1 ml or 1 g of the products;
6.3.3.3. in respect of syrups, emulsions, granular and other pharmaceutical forms to be administered nomērīto quantities-for each active substance the mass or units of biological activity in the quantities measured;
6.3.4. active substances present in the form of compounds or derivatives shall be described quantitatively by their total mass, and if necessary or appropriate, the mass of the active entity or entities of the molecule;
6.3.5. for medicinal products containing an active substance for which the first registration application in any Member State, the quantitative statement of an active substance which is a salt or hydrate shall be systematically expressed in terms of the mass of the active entity or entities in the molecule. All then registered medicinal products in the Member States shall have their quantitative composition stated in the same way for the same active substance.
7. Development pharmaceutics: 7.1 provides an explanation of the connection component and container selection and the intended function of the excipients in the finished medicinal product;
7.2. this explanation add scientific data on development pharmaceutics. Determine the dose increase, justified.
8. Description of the method of production: 8.1. this rule 8.3. veterinary medicinal products referred to in the description of the manufacturing method of establishing such that it provides sufficient overview of the nature of the production operation;
8.2. the description shall include the following: 8.2.1. reference to the various production stages in order to allow an evaluation of whether the pharmaceutical form used in the production process might have produced an adverse change in the constituents;
8.2.2. in the case of continuous manufacture, full details concerning precautions taken to ensure the homogeneity of the finished product;
8.2.3. the actual manufacturing formula, with the detailed quantitative particulars of all the substances used. The quantities of excipients, being given in approximate terms in so far as the pharmaceutical form makes this necessary. Lists all substances that may disappear in the course of manufacture. Indicate any overage and justify it;
8.2.4. a statement of the stages of manufacture at which sampling is carried out for in-process control tests, where other data in the documents supporting the application for registration, indicate the need for quality control of the finished product;
8.2.5. experimental studies validating the manufacturing process, where a non-standard method of manufacture is used or where it is critical for the product;
8.2.6. for sterile medicinal products, details of the sterilization processes used and/or disinfection measures.
9. control of raw materials: 9.1. for the purposes of this paragraph, "starting materials" shall mean any medical content and, where appropriate, the container components, as referred to in this annex, the bottom paragraph 6.1;
9.2. in case it is: 9.2.1. an active substance not described in the European Pharmacopoeia or in the pharmacopoeia of a Member State;

9.2.2. active substance described in the European Pharmacopoeia or in the pharmacopoeia of a Member State which, when prepared by a method liable to leave impurities not mentioned in the Pharmacopoeial monograph and for which the appropriate quality control monograph is not appropriate. If it is produced by a person other than the applicant for registration, the registration, the applicant may arrange for the manufacturer of the active substance is not supplied directly to the competent authorities a detailed description of the manufacturing method, quality control during manufacture and process validation. In this case, the manufacturer shall provide to the applicant for registration all information necessary for registration the applicant would assume responsibility for the medicinal product. The manufacturer shall confirm in writing to the applicant for registration that the manufacturer provides a whole series of consistency and the manufacturer without registration the applicant not modify the manufacturing process or specifications. Competent authorities shall submit the documents and particulars supporting the application for such a change;
9.3. the messages and documents accompanying the application for certificate of registration according to the rules and 13.10 this 13.9. in and 18, 19, 20 and 21 the requirements set out in paragraph, include all components used in the quality control test results, including an analysis of the series concerning the active substances. The results shall be submitted in accordance with the following conditions;
9.4. starting materials listed in pharmacopoeias: 9.4.1 the monographs of the European Pharmacopoeia are applicable to all the substances occurring naturally;
9.4.2. of other substances, each Member State may require that, in respect of medicinal products manufactured in its territory comply with the national pharmacopoeia of a Member State;
9.4.3. components that meet the requirements of the European Pharmacopoeia or in the pharmacopoeia of a Member State, the requirements are considered sufficiently appropriate to this provision the requirements of subparagraph 13.9. In this case, a description of the analytical methods can be replaced by a detailed reference to the pharmacopoeia;
9.4.4. If the European Pharmacopoeia or in the pharmacopoeia of a Member State that the raw material is prepared by a method liable to leave impurities not controlled in the pharmacopoeia monograph, these impurities and their maximum tolerance limits and describes the application of the test procedure;
new item 9.4.5. colours in all cases comply with this provision the requirements of annex 4;
9.4.6. the regular tests, the raw material for each series meets the tests specified in the application for the certificate of registration. If the tests, which are not mentioned in the Pharmacopoeia, then provide evidence that the supplies comply with the quality requirements laid down in the pharmacopoeia;
9.4.7. If a specification that is in the European Pharmacopoeia or in the pharmacopoeia of a Member State is not sufficient to ensure the quality of the substance, the State Agency of medicines may request the registration of the holder of the authorization specifications, ensuring the quality of the substance;
9.4.8. the State Agency of medicines shall inform the authorities responsible for the pharmacopoeia in question. The registration holder shall provide the authorities of that Pharmacopoeia with the details of the alleged insufficiency and the additional specifications applied;
9.4.9. when the starting material is described in the European Pharmacopoeia and the Latvian Pharmacopoeia, compliance with the monograph of a third country pharmacopoeia can be accepted. In such cases, the application for registration, the applicant provide a copy of the monograph accompanied where appropriate, added to the existing test procedure in the monograph of the approval and, if necessary, translation;
9.5. The raw material components that are not listed in any pharmacopoeia monographs describe the way, broken down as follows: 9.5.1. the name of the substance, which comply with this annex to the requirements of point 6.2, add commercial or scientific synonyms;
9.5.2. the definition of the substance, set down in a form used in the European Pharmacopoeia, shall be accompanied by any necessary explanatory evidence, especially that concerning the molecular structure where appropriate. Adds proper synthesis techniques. Where substances can only be described by their method of manufacture, the description shall be sufficiently detailed to characterize a substance which is constant both in composition and in terms of exposure;
9.5.3. methods of identification may be described in the form of complete techniques as used for production of the substance, and how routinely tests to be carried out;
9.5.4. purity tests are described in relation to the total quantity resulting from the expected impurities, especially those which may have a harmful effect, and, if necessary, those which, having regard to the combination of substances to which the application refers, might adversely affect the stability of the medicinal product or distort analytical results;
9.5.5. for complex plants or substances of animal origin indicate the difference between the case where multiple pharmacological effects require the main components of a chemical, physical or biological control, and where the matter is one or more of the main groups of substances with similar activities, which may accept overall assessment method;
9.5.6. If used materials of animal origin, describe measures to ensure the prevention of possible pathogens;
9.5.7. indicate any special precautions which may be necessary for the storage of the starting material and, if necessary, until the maximum check permissible storage period;
9.6. physico-chemical characteristics liable to affect bio-availability: 9.6.1. the following information on active substances (irrespective of whether they are listed in the pharmacopoeia) as active substance in the General description of the components, if it depends on the bio-availability of the medicinal product: 9.6.1.1. crystalline form and solubility coefficients;
9.6.1.2. particle size, where appropriate after pulverization;
9.6.1.3. solvācij stage;
9.6.1.4. oil or water splitting coefficient;
9.6.2.9.6.1.1., and bottom 9.6.1.2 9.6.1.3. paragraph 1 shall not apply to substances used only in the solution;
9.7. If the veterinary medicinal products used in the production of source materials such as microorganisms, tissues of either plant or animal origin, cells or fluids (including blood) of human or animal origin or biotechnological cell constructs, the origin and history of starting materials shall be described and documented;
6.1. Description of the starting material shall include the manufacturing strategy, purification or inactivation methods along with their validation and all procedures relating to the control of the production process with the task to ensure that all product series consistency;

9.9. when cell banks are used, the cell characteristics shall be shown to remain unchanged at the passage level used for the production and beyond;
9.10. seed materials, cell banks, pools of serum and other material of biological origin and, whenever possible, the source materials from which they are derived shall be tested for adventitious agents;
9.11. If it is not possible to avoid the possible presence of pathogenic agents, this material is used only when further processing ensures the Elimination of pathogenic agents and/or inactivation and it is approved.
10. Specific measures to prevent transmission of animal spongiform encephalopathies, the applicant for registration provides that veterinary medicinal products are manufactured in accordance with the Commission's guidance on risk reduction to a minimum on the veterinary medicines carry agents of animal spongiform encephalopathies, the European Commission published the European Community provisions for the regulation of medicines 7. volume, and their most recent versions, which the translation available to the Ministry of Agriculture website.
11. production control tests carried out at intermediate stages: 11.1. news and documents accompanying the application for registration according to the rules and 13.10 this 13.9. in and 18, 19, 20 and 21 the requirements set out in paragraph, include the product control tests that may be performed in an intermediate stage of production, to ensure the technical characteristics and the production process;
11.2. the following tests are essential for checking the conformity of the medicinal formula, if the applicant for the registration of exceptional offers for testing the finished product analysis method, which does not include all of the active substance (or of all the excipient constituents which are subject to the same requirements as the active substances) assessment;
11.3. the same applies where the quality control of the finished product depends on in-process control, especially where the substance in question is essential to determine the method of production.
12. Finished product control: 12.1. control of finished products with a finished product in the series understands what all the units of a pharmaceutical form which are made from the same initial quantity of material and have undergone the same production and/or sterilisation operations or string in a continuous manufacturing process in the case of any given period the Unit produced;
12.2. the registration application list those tests which are carried out routinely on each finished product series. Determine the frequency of the tests, which are not carried out regularly. Specifies the output;
12.3. messages and documents accompanying the application for registration according to the rules and 13.10 this 13.9. in and 18, 19, 20 and 21 the requirements set out in paragraph, include the details of controls carried out, skipping the finished products. They shall be submitted in accordance with the following conditions;
12.4. the general European Pharmacopoeia Monographs or, in their absence, the pharmacopoeia of a Member State, the conditions shall apply to all the products defined there;
12.5. If the use of other test procedures and limit values than those recorded in the European Pharmacopoeia monograph, the General gives evidence that the testing of the made-up case, according to the monograph of Pharmacopoeia shall meet the following quality requirements of the particular pharmaceutical form;
12.6. General characteristics of the finished product: 12.6.1. testing the finished product shall include tests on certain general characteristics of the product. These tests relate to the control of average masses and maximum deviations, to mechanical, physical or microbiological tests, organoleptic characteristics, physical characteristics such as density, pH, refractive index, etc. Application for registration by the applicant in each particular case by the standards and the tolerance limits for each of these characteristics;
12.6.2. exact and detailed description of the testing conditions, where appropriate, the equipment or hardware and standards, if they are not given in the European Pharmacopoeia. The same applies to the methods prescribed by such pharmacopoeias are not applicable;
12.6.3. in addition, the solid dosage forms, which can be entered through the mouth of in vitro testing of the active substance or substances in the liberation and dissolution rate. The State Agency of medicines has the right to claim such studies also take place in cases where the Administration is another;
12.7. the active substance (s) identification and assessment: 12.7.1. the active substance (s) identification and assessment is conducted in a representative sample from the production batch or in a number of dosage-units analysed individually;
12.7.2. unless there is appropriate justification, the active substance content of the finished product, the maximum acceptable deviation does not exceed 5% at the time of manufacture;
12.7.3. on the basis of the stability tests, the manufacturer recommends and substantiates the active substance content of the finished product the maximum permitted tolerance limits up to the proposed expiry date;
12.7.4. in certain exceptional cases of particularly complex mixtures, once very numerous or very small quantities represented in the evaluation of active substances would require a complex study that hard to take, in respect of each production series, the finished product may not perform one or more of the evaluation of the active substances with the clear condition that these evaluations shall be carried out at intermediate stages of the manufacturing process. This derogation shall not apply to the requirements for these substances. This simplified technique shall be supplemented by a method of quantitative evaluation, enabling the State Agency of medicines to ensure that the medicinal products placed on the market conform to the approved specification;
12.7.5. If physical-chemical methods do not provide adequate information on the quality of the product, then it is necessarily to be carried out in vivo or in vitro biological evaluation. Such evaluation shall include reference materials and statistical analysis, which allows to calculate the confidence level. If you can not do the tests on the finished product, they may be made as the intermediate stage of the manufacturing process;
12.7.6. If paragraph 8 of this annex provides information indicates that the drug is used in the manufacture of the active substance to a significant dose increase, then the control tests on the finished product description where appropriate shall include the chemical changes and, where appropriate, toxicological, pharmacological studies of this subject matter, and possible degradation products and/or assessment;
12.8. identification of constituents of the excipient and rating:

12.8.1. as far as necessary, the excipient components shall be subject at least to identification tests;
12.8.2. procedure for testing offered for the identification of colours, to make sure that such substances are listed in annex 4 to these regulations;
12.8.3. obligatory in respect of preserving agents take an upper and lower limit test for any other excipient component that could adversely affect physiological functions-the upper limit of the test. Upper and lower limit test shall be carried out in relation to the mandatory excipient that may influence the bioavailability of the active substances if the bio-availability of one does not provide other appropriate tests;
12.9. the safety tests – in addition to pharmacological, toxicological tests submitted in the application for registration, the analysis data shall include particulars of safety tests, such as sterility, bacterial endotoxin, pyrogenicity and local tolerance in animals where such test is carried out on a regular basis, ensuring the product quality.
13. Stability test. Particulars and documents accompanying the application for certificate of registration according to the rules and 13.10 this. in paragraph 8.6., submitted in accordance with the following requirements: 13.1. provide a description of the research, which is defined in the application for registration of the applicant, the proposed period of validity, the recommended storage conditions and the specifications at the end of the period of validity;
13.2. medicated feed animal in the case of premixtures, where relevant, information on the therapeutic validity of animal feed produced from these pre-mixes in accordance with the recommended instructions for use;
13.3. If the finished product to restore the required details for the renewed drug recommended expiration date, with the corresponding data for stability;
13.4. in the case of multiple dose packaging for stability data submitted in support of the validity of the package after the first opening;
13.5. If the ready product can lead to degradation products the applicant for registration shall be presented and indicate characterization methods and testing procedures;
13.6. the conclusions shall contain the results of analyses, justifying the proposed expiration date recommended storage conditions and the specifications of the finished product in the finished product at the end of the validity of these recommended storage conditions;
8.5. indicates the maximum level of degradation products in the drug at the end of the period of validity;
13.8. submit a study on the product and container interaction, unless such interaction risk is considered possible, especially when it concerns of injectable products or sprays for oral use.
III. testing for safety and residues 14. the particulars and documents accompanying the application for registration according to subparagraph 13.10.13. and requirements, submitted in accordance with the requirements laid down in this chapter.
15. Member States shall ensure that the tests are carried out in accordance with the principles of good laboratory practice in accordance with laws and regulations on the requirements of laboratories and laboratory quality of work inspection.
16. Safety testing: 16.1. documents regarding safety reflect: 16.1.1. the potential toxicity of the medicinal product and any dangerous or undesirable effects which may be conditions under which the veterinary medicinal product to animals. The potential toxicity and side effects be assessed in relation to the severity of the pathological condition concerned;
16.1.2. the potential harmful effects to humans, which can lead to residues of veterinary medicinal products in foodstuffs obtained from treated animals and what difficulties these residues may create in the industrial processing of foodstuffs;
16.1.3. the potential risks which may result from the exposure of human beings to the medicinal product, for example during its administration to the animal;
16.1.4. potential environmental risks that can lead to the use of veterinary medicinal products;
16.2. all results are reliable and universally valid. Experimental methods and evaluation of results, where appropriate, the use of mathematics and statistical methods. In addition, clinicians (experts, clinical research investigator) informs you about the latest therapeutic potential of the product and on the risks associated with its use;
16.3. in some cases it may be necessary to test the output connection of the metabolites, if they show the residue concerned;
16.4. in respect of the excipient used in pharmacy for the first time, do the same as the active substances.
17. Pharmacology: pharmacological studies 17.1. a fundamental role in clarifying the mechanisms under which medicines derive their therapeutic effect. In part IV of this annex include pharmacological studies carried out on experimental animals and to the target species;
17.2. pharmacological research helps you understand the phenomena of toxicity. If the medicinal product obtains a pharmacological effect without toxic reactions or at such low doses, which can cause toxic reactions, the pharmacological effects are taken into account in assessing the safety of the medicinal product;
17.3. the documents on the safety of medicines in addition to submit details of pharmacological studies conducted with laboratory animals, and all relevant information acquired during the clinical studies to the target animals.
18. Toxicology: 18.1. Single dose toxicity. Research on single-dose toxicity shall be used to establish: 18.1.1. possible effects of acute overdosage in the target species;
18.1.2. possible consequences in case it accidentally input the wrong man;
18.1.3. dose by appropriate use of repeated dose studies;
18.2. studies on single-dose toxicity the acute substance found toxic effects as well as its onset and disappearance of the time;
18.3. these studies used no less than two mammalian species. One mammalian species may replace the animal species for which the medicinal product is intended. Usually explores nothing less than two different types of entry. One of them may be the route you suggest for the target species, or similar. If the user is expected to have significant exposure to the drug, such as inhalation or dermal contact, then explore these uses;

18.4. to reduce the number of animals involved in the experiments and their suffering, constantly developing new protocols, single-dose toxicity testing. Research that is accepted under these new procedures, if they are properly approved, as well as studies carried out in accordance with the existing internationally recognized guidelines;
18.5. repeated dose toxicity: 18.5.1. repeated dose toxicity tests are intended to reveal any physiological and/or pathological changes caused by the investigational product the active substance or combination of active substances, and reapply to determine these changes depending on the dosage dosage;
18.5.2. where medicinal products or substances not intended for use in food-producing animals, carried out repeated dose toxicity study in one species of experimental animals. This study you can do research in the target animal. The type and frequency of administration, as well as the duration of the study, pursuant to the choice of the intended clinical use. Researcher argues the amount and duration of the trial, as well as the choice of doses;
18.5.3. where medicinal products or substances intended for use in food-producing animals, studies carried out no less than two animal species, one of which is not a rodent. Researcher argues the animal species choice, taking into account the available knowledge on product metabolism in animals and humans. The test substance is administered through the mouth. The test duration is at least 90 days. Researchers should clearly define and use the arguments and the frequency and duration of the trial;
18.5.4. maximum permissible dose chosen to detect potential adverse effects. The lowest dose level should not produce any signs of toxicity;
18.5.5. toxic exposure assessment based on observation of behaviour, growth, haematology and physiological tests, especially on excretory as well as autopsy reports and accompanying histological data. Each test group choice and range depends on the animal species and from current scientific knowledge;
18.5.6. if known, which surveyed in accordance with the requirements of this regulation, joining the new combinations, the researcher can modify the repeated-dose tests, indicating the modification, if the toxicity tests do not show any potentiation or novel toxic effects;
18.6. tolerance in the target species, provide details of any intolerance symptoms observed by the study of the target species in accordance with this annex to the requirements of paragraph 28. State: 18.6.1 the related study, the dose at which 18.6.2. to suffer intolerance, 18.6.3. relevant species and varieties which show the intolerance, 28.6.4. detailed information about any unexpected physiological changes, conducting research;
11.6. reproductive toxicity including teratogenicity studies of the effects on reproduction: 18.7.1. study is to define the potential of male or female reproductive function deterioration or potential adverse effects on the offspring due to the investigational medicinal product or substance;
18.7.2. substances or medicinal products intended for use in food-producing animals, studies of the effects on reproduction shall be carried out as a two-generation study of at least one species, usually rodents. The investigational substance or medicinal products shall be entered in the male and female animals in an appropriate period before mating. The investigational substance or medication continues to enter until the F2 generation weaning. Use not fewer than three doses. The maximum dose should be chosen in order to detect potential adverse effects. The lowest dose level not showing signs of toxicity;
18.7.3. evaluation of the effects on re productive based on fertility, pregnancy and maternal behaviour; The suckling, growth and development of the F1 offspring from fertilisation to maturity; -The development of the F2 offspring to weaning;
18.7.4. study on the toxic effects to the embryo or fetus, including teratogenicity;
18.7.5. substances or medicinal products intended for food-producing animals, studies on the toxic effects to the embryo or fetus, including teratogenicity. These studies will be carried out in at least two mammalian species, typically with one of the rodents and rabbits. A detailed presentation of the terms of the test (number of animals, dose, injection time and criteria for evaluating the results) is dependent on the level of scientific development to the application for registration and of statistical importance level you expect from these results. Studies with rodents can be combined with the study of effects on reproductive function;
18.7.6. substances or medicinal products intended for food-producing animals, studies on the toxic effects to the embryo or fetus, including teratogenicity, shall be at least one species, which may be the target species, if the medicinal product is intended for use in potential breeding animals;
12.8. mutagenicity: 18.8.1. mutagenicity tests provide, in order to assess the ability of a substance to cause transmissible changes in the genetic material of cells;
18.8.2. new substances intended for use in veterinary medicinal products evaluated in relation to their mutagenic characteristics;
18.8.3. the number and types of tests and evaluation criteria for the appropriate level of scientific progress at the time when the application for registration;
11.7. carcinogenicity: 18.9.1. long-term study with respect to carcinogenicity substance that animals exposed to people. 18.9.1.1. After this substance: chemical composition by analogy to similar to known carcinogens;
18.9.1.2. mutagenicity tests produce results for carcinogenic effects;
18.9.1.3. during the test the toxicity presented signs of carcinogenic effects;
18.9.2. carrying out studies concerning the carcinogenicity and evaluating their results, taking into account the State of scientific knowledge at the time of application;
18.10. exception – if the medicinal products intended for use locally, the research performed on the systemic absorption in the target species of animal. If it is shown that systemic absorption is negligible, then you can not make repeated dose toxicity tests, tests on reproductive toxicity and carcinogenicity tests, unless it is proved that: 18.10.1. in accordance with the specific conditions of use, you may take medications through the mouth;
18.10.2. medicine particles may enter foodstuffs obtained from the treated animal (intramammary preparations can be entered).
19. other requirements: 19.1. immunotoxicity:

19.1.1 if animals in repeated dose studies, the observed effects include specific changes for lymphatic organ weights and/or histology and cell formation changes in lymphoid tissues, bone marrow or peripheral leukocytes, the investigator shall decide on the need for further research on the effects on the immune system of the medicinal product;
19.1.2. in carrying out these studies and evaluating their results, taking into account the State of scientific knowledge at the time of application;
19.2. microbiological properties of residues: 19.2.1. possible effects on the human intestinal flora, microbiological risk, the human gut microbial causes for connection with antimicrobial properties, according to the State of scientific knowledge at the time of application;
19.2.2. possible effects on the industrial processing of food organisms used – in some cases, you can perform tests to determine whether residues cause difficulties for technological processes of the industrial processing of foodstuffs;
19.3. the observations concerning the human body, the details of their, or components of the veterinary medicinal product are used as medicinal products in human therapy. If such a fact exists, then provides an overview of all the effects observed (including adverse effects) for people and for this reason the impacts in order to allow for the evaluation of veterinary medicinal products, taking into account the results of research bibliography. If components of the veterinary medicinal product is not used or are no longer used as medicinal products in human therapy, the reasons.
20. Ecotoxicity: 20.1. the study of the ecotoxicity of a veterinary medicinal product is to assess the potential harmful effects which the use of the product on the environment and to identify any precautionary measures which may be necessary to reduce such risks;
20.2. ecotoxicity assessment is mandatory for the registration application to the licence, excluding the submissions submitted in accordance with these rules and 13.10. in paragraph 8.6. and 18, 19, 20 and 21 the requirements set out in paragraph;
20.3. the assessment shall be carried out in two stages. In the first stage, the investigator shall assess the potential extent of the medicinal product, its active substances or relevant metabolites into the environment, taking into account: 20.3.1. the target species and the proposed pattern of use (for example, drug use or mass administration of certain animals);
20.3.2. the use, in particular the extent to which the product will enter directly into environmental systems;
20.3.3. the medicinal product, its active substances or metabolites in the possible release of the environment by treated animals and persistence in such excretia;
20.3.4. of unused medicinal product or waste disposal;
20.4. the second phase, taking into account the environmental impact of the medicinal product volume and available information on its composition, physical/chemical, pharmacological and/or toxicological properties of the obtained by other tests and trials provided for in these rules, shall decide on the need for further studies on the impact on specific ecosystems;
20.5. may require further research on: 20.5.1. survival and functioning of soil;
20.5.2. the preservation and operation of water and air;
20.5.3. effects on aquatic organisms;
20.5.4. effects on other organisms of a species;
20.6. the further studies will be carried out in accordance with the test protocols laid down in the regulations on laboratory methods for chemicals and chemical products, physical, chemical, toxicological or ecotoxicological properties. If the test protocols are not clearly stated deadline, further studies will be carried out in accordance with other internationally recognized protocols on the veterinary medicinal product and/or the active substances and/or the isolated metabolites as appropriate. The number and types of tests and evaluation criteria for the appropriate level of scientific progress at the time when the application is submitted.
21. Safety tests as in any scientific work, the dossier shall include the following information: 21.1. introduction defining the subject, accompanied by any useful bibliographical references;
21.2. the detailed identification of the substance under review, including: 21.2.1. international non-proprietary name (INN);
21.2.2. the international theoretical and practical chemistry (IUPAC) nomenclature of Association;
21.2.3. Overview of the chemical analytical index (Chemical Abstract Service-CAS) number;
21.2.4. therapeutic and pharmacological classification;
21.2.5. synonyms and abbreviations;
21.2.6. structural formula;
21.2.7. molecular formula;
21.2.8. molecular weight;
21.2.9. level of impurities;
21.2.10. impurities in the qualitative and quantitative composition;
21.2.11. a description of the physical characteristics;
21.2.12. melting point;
21.2.13. boiling point;
21.2.14. vapour pressure;
21.2.15. solubility in water and organic solvents expressed in g/l, with indication of temperature;
21.2.16. density;
21.2.17. rotation spectra of refraction, etc.;
21.3. a detailed experimental protocol giving the reasons for any omission of certain tests listed above, a description of the methods, apparatus and materials used, details of the species, breed or strain of animals, news of the acquisition, the number of animals, housing conditions and feeding conditions, inter alia, determining whether the animals are free from specific pathogens (SPF);
21.4. the results obtained, whether favourable or unfavourable. Original data description in sufficient detail, so that results can be critically evaluated, irrespective of the author's interpretations. Explaining the results, it can be supplemented with illustrations;
13.4. a statistical analysis of the results, where such is called for by the test programme, and variance within the data;
21.6. an objective discussion of the results obtained, which allows to conclude on: safety, 21.6.2 21.6.1. the safety margin in the test animal and the target animal and 21.6.3. potential side effects, 21.6.4. fields of application, 21.6.5. active dose levels, 21.6.6. any possible incompatibilities;
21.7. the detailed description and a thorough discussion of the results of the study concerning the safety of residues in food and their relation to the potential risks caused by residues to humans. This solution meets the suggestions with the aim of ensuring to reduce any risks to humans by applying internationally recognized assessment criteria (for example, no observed effect level in animals, proposals for a choice of safety factor and for acceptable daily intake (ADI));

21.8. a thorough discussion of any risks for persons preparing the medicinal product or administering it to animals. Discussion shall be accompanied by proposals for appropriate measures to reduce such risks;
13.6. a thorough discussion of any risks to the environment, which can lead to the use of the medicinal use of the proposed terms, followed by appropriate proposals to reduce such risks;
21.10. the relevant information to the clinician as fully as possible learn about the usefulness of the proposed drug. Add discussion suggestions for side effects and possible treatment for acute toxic reactions in animals used in medicine;
21.11. the opinion of the expert report which provides a detailed critical analysis of the information referred to above in accordance with development level of science to the application at the time the detailed summary of relevant safety tests and precise bibliographical references.
22. testing for residues: 22.1. in these regulations, "residues" means any active substances or metabolites thereof which remain in meat or other foodstuffs produced from the animal to which the medicinal product used;
22.2. residue studies aim: 22.2.1. or residues persist in foodstuffs obtained from animals to which you applied and, if retained, then, under what circumstances and to what extent, 22.2.2. determine the time of the withdrawal, to be followed in order to prevent danger to human health and/or difficulties in the industrial processing of foodstuffs;
22.3. assessing the levels of risks, determine whether residues remain in the animals treated with the medicinal product under the proposed conditions of use, and explore the effects of residues;
22.4. veterinary medicinal products intended for food-producing animals, residue documentation shall specify: 22.4.1. to what extent and how long the veterinary medicinal product or its metabolites residues remain with medicines in the tissues of the treated animal or foodstuffs obtained therefrom;
22.4.2. realistic withdrawal periods which can be observed under practical farming conditions, to avoid any risk of the treated animal foods to the health of the consumer, or difficulties in the industrial processing of foodstuffs, 22.4.3. the availability of practical analytical methods suitable for routine use to confirm the withdrawal period.
23. Metabolism and residue Kinetics: 23.1. pharmacokinetics (absorption, distribution, biotransformation, excretion): 23.1.1. residues of veterinary medicinal products farmakokinētisko studies will be carried out in order to evaluate the product absorption, distribution, biotransformation of target species, as well as the release of it;
23.1.2. finished products or bio-equivalent form is used in the target species, the maximum recommended dose;
23.1.3. respecting the use, in the description of the medicinal purposes, Castle absorption. If it turns out that the use of medicines locally systemic absorption is negligible, you do not need to do further residue studies;
23.1.4. describe the distribution of the medicinal product in the target animal. The possibility of drugs bind plasma proteins or switch in milk or eggs and the accumulation of lipophilic compounds;
23.1.5. the withdrawal of the description paths of target animal organism. Identifies and describes the major metabolites;
23.2. depletion of residues: 23.2.1. studies on residues depletion in the target animal after the last administration times out in order to determine the withdrawal period;
23.2.2. at different times after the test animal has received the last dose of the veterinary medicinal product, determine the existing levels of using appropriate physical, chemical or biological methods. Specify the technical procedures and methods used for reliability and sensitivity.
24. regular analysis method for the detection of residues: 24.1. the methods of analysis shall be carried out in the course of regular inspections and having the sensitivity level allows you to clearly identify the maximum allowable residue levels exceeding the medicinal product;
24.2. the proposed analysis method is described in detail. It is approved and reliable to use normal regular monitoring for residues;
15.1. describe the following characteristics: 24.3.1. specificity;
24.3.2. accuracy, including sensitivity;
24.3.3. accuracy;
24.3.4. limit of detection;
24.3.5. breakdown of quantities;
24.3.6. practicality and usability in normal laboratory conditions;
24.3.7. sensitivity to disturbance;
15.2. the suitability of the proposed analysis methods to assess, according to the level of scientific progress at the time when the application for registration.
25. Residue test as in any scientific work, the dossier shall include the following: 25.1. an introduction defining the subject, accompanied by any useful bibliographical references;
25.2. the detailed identification of the medicinal, including: 25.2.1.;
25.2.2. purity;
25.2.3. party identification;
25.2.4. relationship to the final product;
25.2.5. highlighted the specific activity of the substances and radiological purity;
25.2.6. position of labelled atoms in the molecule;
25.3. a detailed experimental protocol, which justified the omission of certain tests listed above, a description of the methods, apparatus and materials used, details of the species, breed or strain of animals, number of animals, for the acquisition, housing conditions and feeding conditions;
25.4. the results obtained, whether favourable or unfavourable. Original data description in sufficient detail to allow the results to be critically evaluated independently of the author's interpretations. The results can add illustrations;
25.5. a statistical analysis of the results, where such is called for by the test programme, and variance within the data;
6. an objective discussion of the results obtained, accompanied: 25.6.1. proposed maximum residue levels for active substances of medicinal products, the question of the marķieratliekviel and the target tissue, 25.6.2. suggestion for the required withdrawal time, which ensures that food products derived from animals treated with the drug, not the residue that could endanger consumer products;
25.7. the opinion of the expert report which provides a detailed critical analysis of the information referred to above in accordance with development level of science registration at the time of the application, a detailed summary of the residue tests and precise bibliographical references.
IV. Non-clinical and clinical studies

26. Non-clinical and clinical studies: 26.1. messages and documents, according to these rules and 13.10. in paragraph 8.6. and 18, 19, 20 and 21 the requirements set out in paragraph adds a registration application shall be submitted in accordance with this annex, 27, 28 and 29, the requirements set out in paragraph;
26.2. the clinical requirements-non-clinical studies are needed to determine the pharmacological activity and tolerance.
27. Pharmacology: 27.1. pharmaco-dynamics. Pharmacodynamic studies followed two different approaches to the issue: 27.1.1. first, accurately describes the mechanism of action and pharmacological effects based on which the proposed use in practice. The results shall be expressed in quantitative criteria (for example, using dose-effect curves, time-effect curves etc.) and compared with the substance, which is well known. If the log of a stronger exposure to the active substance, reflects the difference and displays the statistical significance;
27.1.2. Secondly, the study provides a general pharmacological assessment of the active substance, with particular reference to the potential side effects. Overall, explores the main features;
27.1.3. researchers determine the usage of the form URu.tml. effects on the pharmacological effects of the active substance;
27.1.4. studies reinforce, if the recommended dose is the dose that can cause side effects;
27.1.5. experimental methods, if they are standard methods described in such detail as to allow them to be reproduced, and the researchers make their approval. The results of the experiment are clearly set out and specific test case indicates the statistical significance;
27.1.6. If there is no sufficient justification to the contrary, any quantitative modification was also investigated for reaction arising from substance use;
27.1.7. herbal compounds can be used for pharmacological or clinical indication. In the first case, the pharmacodynamic and pharmacokinetic studies or interactions that can result in the same connection, in the context of its clinical application. In the second case, where scientific justification for the drug connection trying to get clinical experimentation, studies indicate, or effects that are expected from the connection, you can play with the animals. Finally, check the side effects of any significance. If the connection includes a novel active substance, prior in-depth study;
27.2. pharmacokinetics: 27.1. usually the clinical context is useful for basic pharmacokinetic particulars concerning a new active substance;
27.2. the pharmacokinetic objectives can be divided into two main areas: 27.2.1. descriptive pharmacokinetics leading to the evaluation of basic parameters such as body clearance, volume of distribution, mean residence time, etc;
27.2.2. use of these parameters to investigate the relationships between dosage regimen, plasma and tissue concentration and pharmacologic, therapeutic or toxic effects;
27.3. target species normally pharmacokinetic studies to use drugs with the greatest possible efficacy and safety. The research is particularly useful to help the clinician to determine dosage regimens (route and location, dose and interval between doses, the number of times to enter, etc.) and to adopt the appropriate dose regimens defined variable indicators for the population (e.g., age, disease). Such studies can be more efficient, it will take a number of animals, and they usually provide more information than classical dose titration studies;
27.4. If the new combination using the known substances that are investigated in accordance with the requirements of these provisions, there is no need to make a fixed combination pharmacological studies, if it can be justified that the administration of the active substance in the form of a fixed combination does not change their pharmacokinetic properties;
27.5. bioavailability (bioequivalence). Appropriate bioavailability studies to establish bioequivalence: 27.5.1. If new formulated drug compared with the already existing;
27.5.2. If new types or methods compared with the already existing;
27.5.3. in the cases referred to in this provision 22, 23 and 24.
28. Tolerance of target species: 28.1. the aim of this study is all animal species for which the veterinary medicinal product intended to perform local and General tolerance trials to determine the tolerated dose, which is so wide, to allow for sufficient safety thresholds and determine the clinical symptoms of intolerance using the recommended use or uses, as far as possible, increasing the therapeutic dose and/or duration of use. These studies report shall contain as many details as possible of the expected pharmacological effects and the adverse reactions. They assessed, taking into account the possibility that the animals can be very valuable;
28.2. medications enter at least the recommended route of administration.
29. the resistance. Data on the emergence of resistant organisms are necessary if the medicinal product is used in infectious disease or parasite infestation prevention or treatment of animals.
30. Clinical requirements: 30.1. clinical research aims to show or to substantiate the efficacy of the veterinary medicinal product by the use of the recommended dosage, identify indications and contra-indications according to species, age, breed and sex, the use of veterinary medicinal products instructions, any side effects, safety and tolerance under normal conditions of use;
30.2. If no rationale, clinical studies carried out with control animals (controlled clinical studies). Effects compared with placebo (a specific form of biological medicinal products indiferent that has no direct action in the body) or by withholding from the treatment and/or with a registered medicine, the therapeutic value of which is unknown. Report on the results obtained;
30.3. the methods used for diagnosis. Presentation of results using quantitative or clinical criteria adopted. Used and justify the appropriate statistical methods;
18.9. If the veterinary medicinal product is intended primarily for use as performance enhancer, particular attention: animal production yields 30.4.1.;
30.4.2. animal production quality (organoleptic, nutritional, hygienic and technological qualities);
30.4.3. animal nutritional efficiency and growth;
30.4.4. animal's general health;
5. experimental data confirmed by data obtained by practical circumstances;

30.6. the applicant for registration in certain circumstances for certain therapeutic indications could not provide comprehensive data on therapeutic effect for the following reasons: 30.6.1. indications for which the medicinal product in question is intended are encountered so rarely that the registration applicant cannot expect complete evidence;
30.6.2. the present state of scientific knowledge, comprehensive information cannot be provided;
19.1. the State Agency of medicines of this annex 19.0. in the case referred to in subparagraph registration certificate of the veterinary medicinal product is granted under the following conditions: 30.7.1. the medicinal product in question is to be supplied on veterinary prescription only and may, in certain cases, be administered only under strict veterinary supervision;
30.7.2. instructions for use and any other information draws attention to the official veterinarian, in relation to certain aspects of the available information on medicinal products is not yet complete.
31. Research: 31.1. all veterinary clinical trials shall be carried out in accordance with a set of fully detailed trial protocol which fills in writing before the trial started. The studies involved comply with the welfare requirements of animals, these animals are subject to veterinary supervision. Welfare requirements followed Protocol and the preparation of studies by research;
31.2. the above creates a systematic written procedures for the clinical research organization, conduct, data collection, documentation and approval;
31.3. before the commencement of the study the study used receives the consent of the owner of the animals and can be documented. The owner of the animal shall be informed in writing of the effects after taking part in the study for the disposal of treated animals or food products from treated animals. A copy of this notice, dated and signed by the owner of the animal, including documentation of the study;
19.5. If one study is not done by blind methods, laws on the labelling of the veterinary medicinal product, distribution, and control concerns the labelling of medicines intended for use in veterinary clinical trials. Studies on the use of clear and indelible markings indicate the phrase "for use only in clinical health research".
32. The documents relating to the efficacy of the veterinary medicinal product as in any scientific work, include an introduction defining the subject, accompanied by use of bibliogrāfisko documents.
33. Non-clinical and clinical documents are detailed enough to make a reasonable judgment. Report on any studies and trials, whether the registration application, favourable or unfavourable to the applicant.
34. Report on the clinical observations as details of the results: 34.1. tests demonstrating the pharmacological action;
21.3. tests demonstrating the pharmacological mechanisms underlying the therapeutic effect;
21.3. tests demonstrating the main farmakokinētisko processes.
35. If, in the course of testing any unexpected results, details about it.
36. Not in clinical trials also provides the following detailed information: 36.1. Summary;
36.2. a detailed experimental protocol giving a description of the methods, apparatus and materials used, animal species, age, weight, sex, and animal breed or strain of animals, identification of dose, drug use and graphic;
36.3. statistical analysis of the results;
36.4. an objective discussion of the results obtained, used in the conclusions on the safety and efficacy of the product.
37. If the whole or partial omission of data that justifies it.
38. Reports of clinical rojum in nov: 38.1. all information submitted to each researcher on the individual pages of the Protocol in the event of processing, and the individual to collective Protocol sheets, if the collective processing;
38.2. the submitted information has the following form: 38.2.1. responsible investigator's last name, address, function and qualifications;
38.2.2. place and date of processing, name and address of the owner;
38.2.3. news about the research protocol, describing the methods used, including randomization and blinding, details such as the route of administration, schedule of use, the dose, the study of animal identification, species, breed or strain, age, weight, sex, number, physiological status;
38.2.4. method of rearing and feeding, stating the nature and composition, as well as any additives contained in the feed;
38.2.5. case history (as full as possible), occurrence in the meantime and in the course of the disease;
38.2.6. the diagnosis and the means to be determined by a diagnosis;
38.2.7. the symptoms and severity of the disease if possible according to conventional criteria;
38.2.8. research clinical trials used in the wording of the exact identification;
38.2.9. drug dose, route of administration, the method and frequency, as well as precautionary measures during the use of the medicinal product (injection time etc.), if any;
38.2.10. the processing and subsequent duration of the period of observation;
38.2.11. all details concerning medicinal products (other than those investigating), which can be used during the examination or before investigational medicinal products, or simultaneously with them, and in the latter case, detailed information on the observed interaction;
38.2.12. the results of the clinical trials (including unfavourable or negative results), the full set of clinical observations and objective tests of activity (laboratory studies, physiological tests), required to evaluate the application. Indicate the methods used and explain the significance of any variations in the results (such as methods, variance variance between individuals or the effects of medicinal products). Pharmacodynamic effects for animals is not enough to justify an opinion on any therapeutic effect;
38.2.13. all particulars of any unintended effects, whether harmful or not, and of any measures taken as a result. The exploration of possible cause-and-effect relationship;
38.2.14. impact on the total value of the animals (e.g. egg-laying, milk production and reproductive function);
38.2.15. impact on the quality of foodstuffs obtained from treated animals, particularly in the case of medicinal products intended for use as performance enhancers;
38.2.16. opinion on each individual case or, where collective treatment is concerned, on each collective case.

38.3. If not apply one or more of the requirements of this annex to section 38.2.1.38.2.16., justify it;
23.9. the holder of the registration certificate shall take the necessary measures to ensure that the original documents that form the basis of the data submitted, possession of not less than five years after the veterinary medicinal product is no longer authorised.
39. Summary and findings on clinical observations. For each clinical trial clinical observations and the results of the studies summarized in the synopsis, in particular: 24.3. the number of controls, the number of animals treated either individually or collectively, in preparing the document to species, breed or strain, age and sex;
24.4. the number of animals withdrawn prematurely from the studies and reasons for such withdrawal;
39.3. in the case of control animals, whether they are: processing received 39.3.1.;
39.3.2. received a placebo;
39.3.3. received another medicinal product of known registered effects;
39.3.4. received the active substance being studied in other formations or other use;
24.5. the observed frequency of side effects;
24.5. observations on the effect on values (e.g. egg-laying, milk production, reproductive function and food quality);
24.6. news about animals, which may have increased risk, taking into account their age, breeding or feeding, or purpose, which are intended, or animals the animals for which the physiological or pathological State decides in particular;
24.7. a statistical evaluation of the results when this is called for by the test programme;
24.7. In conclusion the investigator made the General conclusions from the experimental evidence, expressing her opinion about the safety of the medicinal product under the proposed conditions of use, its therapeutic effect and any useful information relating to indications and contra-indications, dosage and average duration of treatment interactions observed with other medicinal products or feed additives as well as special precautions to be taken during use of the product, and clinical symptoms of overdose;
24.8. fixed combination drug case, the researchers draw conclusions regarding the safety and efficacy of the medicinal product, compared to the use of individual active substances.
40. The expert report by the opinion. In the opinion of the expert's report provides a detailed, all before the clinical and clinical documentation for critical analysis according to the scientific development to the level of the application for registration. Then add a detailed summary of tests and results of research and precise bibliographical references.
Minister of agriculture, the Minister of Interior Or the Ministry of agriculture in Jaundžeikar. submit the annex 3 of the Cabinet of Ministers of 18 July 2006, regulations no 600 requirements imunoloģiskaj veterinary medicinal products (I). A summary of the dossier administrative data 1:1.1. immunological veterinary medicinal product which is the subject of the registration application shall be identified by the name of the medicinal product and the name of the active substance, pointing to strength, pharmaceutical form, route of administration and usage, as well as final sales presentation;
1.2. the application for registration presented the applicant's name and address, the name and address of the manufacturer and the sites involved in the various stages of production, including the manufacturer of the finished product and the manufacturer of the active substance and, where applicable, the name and address of the importer;
1.3. the registration applicant shall indicate precisely the number and name of the document, which shall be annexed to the application for registration, and information on samples submitted, if any;
1.4. the data in the application for registration be accompanied;
1.4.1. copies of documents proving the right of producers to produce immunological veterinary medicinal products according to the regulations on procedures for the issue, suspend, and revoke the re-registered at the special permission (license) veterinārfarmaceitisk action 1.4.2. list of organisms handled the production site;
1.5. the registration application, the applicant shall submit a list of countries in which he granted permission to copy from the description of the veterinary medicinal product in accordance with the provisions of paragraph 35, which are approved by the Member States, and a list of those Member States in which application for registration is submitted.
2. the summary of product characteristics, when the registration applicant: 2.1 offers a summary of product in accordance with the provisions of paragraph 35;
2.2. presentation of one or more of the immunological veterinary medicinal product samples or advertising mock-ups and instructions for use, if needed.
3. Expert reports: 3.1 in accordance with the provisions of paragraph 35 requirements submitted expert reports on all aspects of the dossier;
3.2. each expert report shall be established in accordance with the requirements of this regulation made a critical test and study evaluation which includes data relating to the assessment. Expert gives an opinion on whether there is reasonable assurance of the quality of the medicinal product concerned, safety and efficacy. A summary of the facts without opinion is insufficient;
3.3. all relevant data compiled in an annex to the expert report, whenever possible, tables or graphical way. The expert report and the summaries shall contain precise cross references to the information contained in the documents;
3.4. each expert report shall be prepared by a suitably qualified person with appropriate experience. The expert report is signed and dated, and the expert report shall be accompanied by a short news about expert education and professional experience. Specifies the applicant's expert and professional relationships.
II. The immunological veterinary medicinal product analytical (physico-chemical, biological or microbiological) tests of 4. testing procedures used meet current scientific progress and approved procedures. Indicates the results of the validation studies.
5. test procedure (procedure) for a detailed description of this procedure can be repeated in control tests, carried out at the request of the State Agency of medicines. Description of the special equipment to be used and the equipment, adding the scheme. If necessary, laboratory reagent formula description shall be supplemented by a description of the method of preparation. If the testing procedures included in the European Pharmacopoeia or in the pharmacopoeia of a Member State, the test procedure description may be replaced by a detailed reference to the European Pharmacopoeia or in the pharmacopoeia of a Member State.

6. submission of registration this provision added in point 13.3. information and documentation on veterinary medicinal products, active substances constituting the components and the qualitative and quantitative composition shall be submitted in accordance with the following conditions: 6.1 of the immunological veterinary medicinal product "qualitative particulars" of all the constituents that are named and described: 6.1.1. active substance (substances);
6.1.2. the excipient components;
6.1.3. the constituents of the excipients, whatever their nature or the quantity. The excipient components include preservatives, stabilizers, emulsifiers, colouring matter, taste and aromatic substances, markers URu.tml.;
6.1.4. animals-use form components;
6.2. information about the vessel and its sealing system together with details of devices with which the immunological veterinary medicinal product will be used or administered and which will be delivered complete with a medicinal product;
6.3. the "usual terminology", used to describe the immunological veterinary medicinal product components regardless of this rule 13.3. other conditions for the application of subparagraph, means: 6.3.1. substances which appear in the European Pharmacopoeia or, if they are not, in the national pharmacopoeia of a Member State, the relevant Pharmacopoeial monograph substances specified principal name, which becomes obligatory for all such substances, with reference to relevant Pharmacopoeial monograph;
6.3.2. other substances, the international non-proprietary name recommended by the World Health Organization, which may be accompanied by another non-proprietary name, or, failing these, the exact scientific name. Substances not having an international non-proprietary name or an exact scientific designation shall be described by defining how and from what they were prepared, supplemented, where appropriate, by any other relevant details;
6.3.3. in relation to the designation of colours with the "E" code assigned to them based on this rule, the requirements of annex 4;
6.4. the quantitative particulars: 6.4.1. to provide the immunological veterinary medicinal products the active substance quantitative particulars, should specify: 6.4.1.1. the number of organisms, the specific protein content, the mass, the international unit (IU) or units of biological activity, the number of dosage unit or volume, and excipients excipient 6.4.1.2. components of mass and volume (each of them) according to paragraph 8 of this annex to the requirements.
6.4.2. If an international unit of biological activity, use the 6.4.3. biological activity for which no published data, providing unambiguous information on the activity of components, such as determining the effects of immunological, underpinning the method of determining the dose.
7. The pharmaceutical design provides an explanation of the veterinary medicinal product is composed of immunological, ingredients and packaging, adding scientific data on development pharmaceutics. Determine the dose increase, justified. Demonstrate any preservative system efficiency.
8. the finished product, the description of the manufacturing method shall be prepared as follows: 8.1 description of the manufacturing method, which according to this provision is added to paragraph 13.4. registration application, provide adequate review of the nature of the production operation;
8.2. the description of the manufacturing method shall include at least the following: 8.2.1. depicting the various stages of manufacture (including purification procedures) so that an assessment can be performed: 8.2.1.1. the repeatability of the production procedures, the risk of adverse 8.2.1.2 finished products as the risk of microbiological contamination, 8.2.2. in the case of continuous manufacture, full details concerning precautions taken to ensure the finished product all series homogēnum and uniformity;
8.2.3. name substances that do not recover in the course of manufacture;
8.2.4. shall provide detailed information on the blending with the quantitative particulars of all the substances used;
8.2.5. points to the production stage, which takes a sample process control.
9. the production of raw materials and control: the meaning of this paragraph 9.1. "raw materials" means materials used in the manufacture of immunological veterinary medicinal product. Of culture medium used in the manufacture of the active substance shall be considered a single raw material;
9.2. If a person other than the applicant for registration, manufacture active substance not described in the European Pharmacopoeia or in the pharmacopoeia of a Member State, or an active substance described in the European Pharmacopoeia or in the pharmacopoeia of a Member State, but they are prepared by a method liable to leave impurities not mentioned in the Pharmacopoeial monograph and for which the appropriate quality control monograph is not suitable for the application for registration, the applicant may request the manufacturer of the active substance for medicine, a government agency in a detailed description of the production method , quality control during manufacture and process validation;
9.3. this annex 9.2. in the case referred to in subparagraph provided by the manufacturer of the active substance registration applicant information which it needs to take responsibility for veterinary medicinal products. The manufacturer of the active substance shall confirm in writing to the applicant for registration that a manufacturer provide the whole series consistency and without registration the applicant not modify the manufacturing process or specifications. The State Agency of medicines of the registration applicant or manufacturer shall submit documents and particulars supporting the application, of the registration documentation of such changes;
9.4. messages and documents accompanying the application for registration according to the rules and 13.10 this 13.9. in and 18, 19, 20 and 21 the requirements set out in paragraph, include ingredients used in quality control test results and submitted in accordance with the following conditions: 9.4.1 the materials listed in pharmacopoeias: 9.4.1.1. Monographs of the European Pharmacopoeia are applicable to all the substances occurring naturally;
9.4.1.2. in respect of other substances, each Member State may request that its territory products produced in observance of its own national pharmacopoeia;
9.4.1.3. components that meet the requirements of the European Pharmacopoeia or in the pharmacopoeia of a Member State requirements, is considered satisfactory according to the rules, the requirements of paragraph 13. In this case, the description of the analytical methods may be replaced by a detailed reference to the pharmacopoeia in question;
9.4.1.4. may allow the reference to third country pharmacopoeia, if the substance is not described in the European Pharmacopoeia. In this case, submit third country pharmacopoeia monographs, which, if necessary, be accompanied by a translation, which is the responsibility of the applicant for registration;

9.4.2. colours correspond to the provisions of annex 4;
9.4.3. regular tests carried out on each raw material series, is that, as declared in the application for registration. If the tests, which are not mentioned in the Pharmacopoeia, then provide evidence that the supplies comply with the quality requirements laid down in the pharmacopoeia;
9.4.4. If the specification or other provisions recorded in the European Pharmacopoeia or in the pharmacopoeia of a Member State, may not be enough to ensure the quality of the substance, the competent authorities may require from the applicant the application for registration in accordance with the specifications;
new item 9.4.5. the State Agency of medicines shall inform the authorities responsible for the pharmacopoeia in question. The application for registration, the applicant shall provide the authorities of that Pharmacopoeia with the details of the alleged insufficiency and the additional specifications applied;
9.4.6. If the starting material is described by the European Pharmacopoeia or in the pharmacopoeia of a Member State, medicine State agency compliance with the monograph of a third country pharmacopoeia can be accepted. In such cases, the applicant for registration provides a copy of the monograph accompanied, if necessary, added the test procedure specified in the monograph approval and translation. It appears that the ability of the monograph to control enough active ingredient quality.
10. Starting materials not in a pharmacopoeia: 10.1 raw materials of biological origin: 10.1.1. the description provided in the form of monographs;
10.1.2. possible, vaccine production shall be based on a seed lot system and on existing cell banks. In the manufacture of immunological veterinary medicinal products consisting of serums, got used to the general health and immunological status. Using certain materials series;
10.1.3. Description and document the origin and history of starting materials. About genetically engineered materials this information include: output description cells or strains, vector design description (name, origin, function, replikon Activator Accelerator and other regulatory elements), effectively included in the DNA or RNA sequences control plasmid vector in cells, the primer sequences in the plasmid, kotransfekcij added or removed genes, ready and the biological characteristics of the gene copy number and genetic stability;
10.1.4. cultural materials, including cell banks and raw material preparation of Antisera, the serum is tested for identity and adventitious agents;
10.1.5. information on substances of biological origin used in each stage of the production process. This information includes: 10.1.5.1. details of the source of material resources;
10.1.5.2. details of processing, purification and inactivation, adding the process validation data and control during manufacture;
10.1.5.3. details of the tests carried out for each substance series on pollution;
10.1.6. If additional agents discovered the presence or suspected presence of such relevant material waste diverted or used in exceptional cases, if the further processing of the product provides the additional agents and (or) the disappearance of inactivation. Prove the following additional agent loss and (or) inactivation;
10.1.7. when cell banks are used, the cell characteristics shall not reflect the variability up to the passage level used for the production of the highest level;
10.1.8. for live attenuated vaccines, provide evidence of the attenuation characteristics of the inoculum stability;
10.1.9. If necessary, make organic raw materials or reagents used in the testing procedures, to medicine, a government agency can agree on a test;
10.2. materials which do not originate in bio, description provided in the form of a monograph under the following headings: 10.2.1. raw material, corresponding to the name of this annex to the requirements of paragraph 9.1, adds commercial or scientific synonyms;
10.2.2. Description of raw materials set out in a similar way as the European Pharmacopoeia shall be described in point;
10.2.3. the function of the starting material;
10.2.4. methods of identification;
10.2.5. purity described in relation to the total quantity resulting from the expected impurities, especially those which may have a harmful effect, and those that can negatively affect the stability of the medicinal product or distort analytical results, taking into account the composition of substances covered by the application. Prepare a brief description of the tests carried out to determine the purity of each raw material in the series;
10.2.6. indicates special precautions that may be necessary for the storage of raw materials, and, where appropriate, maximum storage period.
11. Specific measures to prevent transmission of animal spongiform encephalopathies, the applicant for registration provides that veterinary medicinal products are manufactured in accordance with the Commission's guidance on risk reduction to a minimum on the veterinary medicines carry agents of animal spongiform encephalopathies, the latest versions and instructions that are published by the European Commission European Community rules for the regulation of medicines 7. volume.
12. production control tests carried out at intermediate stages: 12.1. news and documents accompanying the application for registration, pursuant to these rules and 13.10. in paragraph 8.6. and 18, 19, 20 and 21 the requirements set out in paragraph, include details of the control tests carried out at intermediate stages of production of a product, to ensure that the manufacturing process and the finished product compliance;
12.2. for inactivated or detoxified vaccines, inactivation and detoxification test each production cycle immediately after the inactivation or detoxification procedure is complete.
13. control of finished products: 13.1 news and documents accompanying the application for registration according to the rules and 13.10 this 13.9. in and 18, 19, 20 and 21 the requirements set out in paragraph, include the details of controls carried out finished products. If there is an appropriate monographs, use the other testing procedures and thresholds, not recorded in the monographs of the European Pharmacopoeia, shall provide proof that the product is ready for the test case, according to the monograph of Pharmacopoeia shall meet the following quality requirements of the particular pharmaceutical form. Registration application records those tests carried out in each of the series of finished products on representative samples. Determine the frequency of the tests, which are performed for each series. Specifies the output;
13.2. General characteristics of the finished product:

13.2.1. testing the finished product shall include tests on certain general characteristics of the product, even if they take place in the production process;
13.2.2. these tests relate to the control of average masses and maximum deviations, to mechanical, physical, chemical or microbiological tests, physical characteristics such as density, pH, refractive index, etc. Application for registration by the applicant in each particular case determine the specifications with the appropriate tolerance limits for each of those characteristics;
13.3. the active substance identification and assessment: 13.3.1. all tests on the finished product a description of the method of analysis set out in detail, so that it can be repeated;
13.3.2. active substances of biological activity assessment product series in a representative sample or in a number of dosage-units analysed individually;
13.3.3. where appropriate by specific identification test;
13.3.4. in exceptional cases with particularly complex mixtures, if very numerous or very small quantities represented in the assessment of active substances required sophisticated study that hard to take each production series, the finished product may not perform one or more of the assessment of the active substance, with the condition that such assessments shall be made as intermediate in the production process later. This derogation shall not apply to the requirements for these substances. This simplified technique shall be supplemented by a method of quantitative evaluation, enabling the State Agency of medicines on the market an immunological veterinary medicinal product compliance with the formula.
14. the identification and assessment of excipients, in so far as testing procedures are available, check the excipient and its quantity and type of ingredients in the finished product.
15. identification of constituents of the excipient and rating: 15.1. as far as necessary, the excipient shall be subject at least to identification tests;
15.2. the test procedure that provides for the identification of colours, to make sure that such substances are authorised under this provision the requirements of annex 4;
15.3. necessarily take an upper and lower limit test for preservatives. The upper limit is a required test for any other excipient component that can cause adverse reactions.
16. Safety tests, in addition to those test results submitted under part III of this annex, shall submit details of safety tests. These tests are studies of drug overdosage of not less than: 16.1. with one of the most sensitive target species;
16.2. the recommended route of administration, posing the greatest risk.
17. Sterility and purity test, appropriate tests to ensure that there is no pollution with additional agents or other substances carried out within the framework of the immunological veterinary medicinal product characteristics, production method and conditions.
18. Inactivation-test production of the final package to confirm inactivation.
19. Residual humidity – each freeze-dried product series check residual humidity.
20. The series of consistency – in order to ensure that the product can reproduce the product series and demonstrate compliance with the specifications for each of the final product is not distributed (cargo) series or finished product testing carried out potenč series based on in vitro or in vivo methods by applying the reference material with the degree of certainty, if available. Potencēšan, in exceptional circumstances, the tests may be carried out as late as possible in the intermediate stage of the manufacturing process.
21. Stability tests: 21.1. the particulars and documents accompanying the application for registration according to the rules and 13.10 this 13.9. in and 18, 19, 20 and 21 the requirements set out in paragraph shall be submitted in accordance with the following requirements: 21.1.1. describe the tests carried out to verify the registration of the application, the applicant proposed validity period. These tests are always researches in real time. It is performed with a sufficient quantity of product series produced in accordance with the described production process and with the products stored in the final package. These tests include biological and physico-chemical stability tests.
21.1.2. opinions are the results of the analyses, justifying the proposed retention period for all proposed storage conditions;
21.1.3. medicinal products to be administered by the food, if necessary, information on the period of validity of the product in different stages of mixing when mixing is carried out in accordance with the recommended instructions for use;
21.2. If necessary before entering the finished product to restore the required details of the renewed drug recommended expiration date. The data submitted in support of the proposed storage period of the reconstituted product.
III. Safety testing 22. Safety tests show the possible risks that can lead to immunological veterinary product use in animals under the proposed conditions of use. The potential risks are assessed in relation to the potential benefits that can give a veterinary immunological products.
23. If the immunological veterinary medicinal product contains living organisms, particularly those that can spread the vaccinated animals, assess potential risk to unvaccinated animals belonging to the same or to another possible subject species.
24. the particulars and documents accompanying the application for registration according to the rules and 13.10 this 13.9. in and 18, 19, 20 and 21 with the requirements laid down in this annex shall be submitted in accordance with the requirements of paragraph 26.
25. The laboratory tests are carried out according to good laboratory practice principles laid down in the regulations on the requirements to the quality of work of laboratory and laboratory inspection.
26. General requirements: 26.1. safety tests carried out in the target species;
26.2. the dose used is the quantity to be recommended for use and containing the maximum titre or potency for which the application for registration has been filed;
26.3. sample used for safety testing of serial or series, produced according to the manufacturing process described in the application for registration.
27. laboratory tests: 27.1. safety of application of one dose:

27.1.1. immunological veterinary medicinal products used and recommended dose in each of the proposed uses of all species and categories of animals to which it will be used, including the animals with the minimum age for the use of the product. The animals shall be observed and investigated to determine systemic and local reactions. This research includes a thorough post-mortem macroscopic and microscopic examination of the injection site. Register the other objective criteria as rectal temperature and total value of the measurements;
27.1.2. the animals shall be observed until no longer expected a reaction, but in all cases, the surveillance and the investigation period is not less than 14 days after administration of the medicinal product;
27.2. the one use in relation to the overdose: 27.2.1. immunological veterinary medicinal product to exceed the dose applied in each of the proposed route of animals from the most sensitive target species categories. The animals shall be observed and investigated to determine systemic and local reactions. Register the other objective criteria as rectal temperature and total value of the measurements;
27.2.2. the animals shall be observed and examined by no less than 14 days after administration;
27.3. the safety of repeated application of one dose: 27.3.1. repeated administration of one dose does not need to reveal any side effects caused by such use. The tests shall be carried out for the most vulnerable category of target species, using the recommended route of administration;
27.3.2. the animals shall be observed and examined not less than 14 days after the last administration of the drug to determine systemic and local reactions. Register the other objective criteria as rectal temperature and total value of the measurement.
28. the reproduction verification: 28.1. reproduction test decides if data indicate that supplies of medicinal products may be a potential risk factor. The reproductive function of male animals and pregnant and non-pregnant female animals for studying with the recommended dose and by each of the recommended route of administration. Study the harmful effects on the progeny, as well as teratogenic and abortion-inducing impact;
28.2. these studies may form under this Annex 27.1. safety components of the research described.
29. the immunological function-if the immunological veterinary medicinal product may have harmful effects on the progeny of the animal in the vaccinated or immune response, appropriate tests shall be carried out by checking the immunological functions.
30. Special requirements for live vaccines: 30.1. the spread of the vaccine strain – explore the spread of the vaccine strain from vaccinated to unvaccinated target animals, using the recommended route of administration that is likely to cause the spread of the vaccine strain. In addition, it may be necessary to investigate the spread of a species other than the target species and which may be the most sensitive in relation to a live vaccine strain;
30.2. vaccinated animals in the spread – check the droppings, urine, milk, eggs, and other secretions of the nose to detect them. You may need to conduct studies on the spread of the vaccine strain in the body, with particular attention paid to the body areas prone to replication of the organism. These studies are conducted, if productive animals live vaccine used against well known zoonoses;
30.3. attenuated vaccines virulence reversion, reversion to virulence study material from the arcade, which is least attenuated between the strain and the final product. The initial vaccination shall be carried out, using the recommended route of administration that is likely to lead to reversion to virulence. For not less than five serial passages in the target species of animals. If it is not technically possible, because the body is not sufficient replication taking so passage as possible in the target species. Where appropriate, between the passage of the in vivo distribution of organisms can be performed in vitro. Passage of the entry that is likely to lead to reversion to virulence;
18.9. biological properties of the vaccine strain. May need other tests to determine as precisely as possible vaccine strain specific biological properties (e.g. neurotropism);
5. rekombinēšan or strain genome rearrangement. Appearance or genomic reassortment with field of upgrading or other strains.
31. Residue studies: 31.1. with respect to immunological veterinary medicinal products usually don't need to conduct research on residues. However, if the immunological veterinary medicinal product used in the manufacture of excipients and/or preservatives shall provide information on the possibility that the food remains in the residue. Where appropriate, examine the effects of such residues. In the case of live vaccines against zoonoses in addition to 30.2. of this annex) (described in the research may require establishing drug injection site;
31.2. recommends the withdrawal period and on its compliance in respect of any type of research that has been carried out.
32. in interact-indicates the known interactions with other products.
33. Field studies, laboratory research results add additional data from field studies, unless it is justified that the field studies are required.
34. Ecotoxicity: 34.1. immunological study of the ecotoxicity of a veterinary medicinal product is to assess the potential harmful effects which the use of the product to the environment and to identify any precautionary measures which may be necessary to reduce such risks;
21.3. ecotoxicity assessment is compulsory for any application for registration of the immunological veterinary medicinal product registration except registration submissions, filed pursuant to these rules and 13.10. in paragraph 8.6. and 18, 19, 20 and 21 the requirements set out in paragraph;
21.3. ecotoxicity evaluation shall be carried out in two stages according to the following conditions: 34.3.1. the first stage the investigator shall assess the potential extent of the medicinal product, its active substances or relevant metabolites into the environment, taking into account: 34.3.1.1. the target species and the proposed pattern of use (for example, medicine or medicinal use the massive individual animal), 34.3.1.2. the method of administration, but especially the extent to which the medication penetrates directly in the system environment, 34.3.1.3., its active substances or relevant metabolites possible withdrawal from the environment by treated animals the conservation of such discharge, 34.3.1.4. of unused medicinal product or waste disposal;

34.3.2. If the findings of the first phase indicate possible effects of medicinal products on the environment, the application for registration, the applicant shall take the second step and evaluate potential ecotoxicity of medicinal products. Registration for this purpose the applicant determine the amount and duration of the environment is subject to the effects of the medicinal product, and details of the physical, chemical, pharmacological and/or toxicological properties of the compound that the other tests and trials provided for in these regulations. If necessary, you can make further studies on the effects of the medicinal product (soil, water, air, aquatic organisms, species not targeted);
21.4. further studies shall be conducted in accordance with the test protocols laid down in the regulations on laboratory methods for chemicals and chemical products, physical, chemical, toxicological or ecotoxicological properties. If not explicitly set in the protocols of research deadline, further studies will be carried out in accordance with other internationally recognized protocols on the veterinary medicinal product imunoloģiskaj and/or active substances and/or distribute the metabolites. The number and types of tests and the results of the evaluation criteria are appropriate to the level of scientific development at a time when the registration application.
IV. Efficacy studies 35. This part describes the research task is to confirm the efficacy of the immunological veterinary medicinal product. The applicant for registration requirements for immunological veterinary medicinal properties, and use the full approved special studies that are attached to the application for registration.
36. the particulars and documents accompanying the application for registration according to the rules and 13.10 this 13.9. in and 18, 19, 20 and 21 with the requirements laid down in this annex shall be submitted in accordance with the requirements of paragraph 26 and with the following provisions: 36.1. veterinary clinical studies carried out in accordance with certain detailed fully in the research protocol, recorded in writing before the start of the study. To ensure compliance with the requirements of animal welfare, the animals involved in the trials are subject to veterinary supervision. Animal welfare requirements are fully observed in preparing the study protocol and research;
36.2. the necessary minimum pre-established systematic written procedures for the clinical research organization, conduct, data collection, documentation and approval;
36.3. before the commencement of the study the study used receives the consent of the owner of the animals and can be documented. The animal owner informed in writing about the consequences after taking part in the study can occur, removing of treated animals or food products from treated animals. A copy of this statement, dated and signed by the owner of the animal, including documentation of the study;
36.4. If one veterinary clinical studies not conducted after the blind methods, labelling conditions laid down in the legislation on the labelling of the veterinary medicinal product, distribution, and control conditions, apply in veterinary medicinal products used in clinical studies of the mark. In a clear and indelible markings indicate the phrase "for use only in clinical health research".
37. the vaccine strain selection, based on the epizootiological data.
38. the Laboratory exposure studies are controlled studies, including untreated control animals, according to the following conditions: 38.1. this research complements the field studies, including Virgin control animals;
38.2. all studies described in sufficient detail so that you can repeat the control studies, carried out at the request of the State Agency of medicines. The researchers presented the methodology used. The results reflect accurately;
23.8. report on the results obtained, regardless of their outcome (whether they were favourable or unfavourable).
39. the efficacy of the immunological veterinary medicinal product is presented for each species and each category of animal, which recommend vaccination, with each recommended route of administration and using the proposed schedule of use. According to evaluate vaccine effects as passively acquired or inherited from the mother's antibodies. Information about the signs of the beginning and the duration of protection shall be approved by the study data.
40. the Multivalent and combined immunological veterinary medicinal products presented in the exposure of each component. If this medicine recommends for use in conjunction with, or with any other veterinary medicinal products medicinal products presented remain compatible.
41. If the product forms part of a vaccination scheme recommended by the applicant for registration must reflect the medicine priming or booster effect or the contribution of the medicinal products the total effect of the vaccination system.
42. reference dose is the quantity to be recommended for use and containing the maximum titre or potency for which the application for registration has been filed.
43. Samples used for efficacy studies, taken from the series or series, produced in the production process, corresponding to the registration set forth in the application.
44. the diagnosis provided the immunological veterinary medicinal product registration application, the applicant indicates, as interpreted in the treated animal reaction to those medicinal products.
45. Laboratory studies: 45.1. the efficacy of the immunological veterinary medicinal product demonstrates well controlled laboratory conditions with the reaction that the target animal provokes the immunological veterinary medicinal product under the proposed conditions of use of the entry. As far as possible, the conditions which make a provocation, reflects a natural infection conditions, for example, taking into account the amount of organism and provocation provocation administration;
45.2. If possible, keep records and documentary description of the immunity mechanism (cell-environment/humoral, local/General classes of imunglobulīn), which is proposed by the administration of the immunological veterinary medicinal product to target animals by the recommended route of administration.
46. Field studies: 46.1. laboratory studies adds additional data from field studies, unless it is justified that the field studies are required;
28.7. If laboratory studies can be justified on efficacy aspects, only allowed to use the field studies.
V. information and documents concerning safety testing and efficacy trials of immunological veterinary medicinal products

47. the documentation on safety and efficacy studies, as in any scientific work, the introduction defines the subject, object, and specifies the tests carried out in accordance with annex III and IV of this part, summary, with references to the literature used. Specifies if the argument is omitted and an annex III and IV of this part specified in the test or studies.
48. studies on laboratory provides the following: 48.1. the summary;
48.2. the name of the authority that carried out the study;
48.3. a detailed experimental protocol, stating: 48.3.1., a description of the methods, apparatus and materials used, details 48.3.2. of the species, breed or strain of animals, categories of animals, the news of the acquisition, the identification of animals and the number of the animal accommodation 48.3.3 conditions and feeding conditions (inter alia, determining whether they are free from any specific pathogens and/or specific antibodies, animal feed additive in nature and quantity) 48.3.4.-use, dose, route of administration, schedule and dates, 48.3.5. statistical methods used;
30.1. in the case of control animals, whether they received the placebo or not received any treatment;
30.1. the General and individual observations and results obtained (with averages and standard deviations), both favourable and unfavourable. The data described in sufficient detail so that results can be critically evaluated, using the author's interpretation. Raw data reflect the table. Explaining and illustrating the results, it can be supplemented with record playback, microfilm photographs URu.tml.;
30.2. the side effects observed characteristics, frequency, and duration;
30.3. the number of animals withdrawn prematurely from the studies and reasons for such withdrawal;
30.3. statistical analysis of the results, where such is called for by the test programme, and variance within the data;
30.4. any additional disease incidence and progress;
48.10. details of medicinal products (other than investigational medicinal products), the use of which was necessary in the course of the study;
48.11. objective discussion of the results obtained, which allows you to draw conclusions on the safety and efficacy of the product.
49. Field studies. News about the field of studying sufficiently detailed, allowing you to create an unbiased judgment. News about field studies include the following: 49.1. Summary;
30.6. the investigator's name, address, title and qualifications;
30.6. the place and time of use, the animal's owner's name and address;
49. details of the trial protocol, which describes the methods, apparatus and materials used, details such as the route of administration, schedule of use, dosage and animal categories, the duration of observation, the serological response and other studies carried out in animals after administration of the medicinal product;
30.8. in the case of control animals, whether they received the placebo or not received any treatment;
30.8. the treated and control animal identification (collectively or individually): species, breed or strain, age, weight, sex, physiological status;
49.7. method of rearing and feeding a brief description of the types of additives in feedingstuffs and the quantity;
49.8. all particulars of the observed facts, assessments and results (with averages and standard deviation). The individual data points when individuals take tests and measurements;
31.0. the results of the clinical studies, whether favourable or unfavourable, in full activity in determining the observations and the results of the objective tests that are required for the evaluation of the product. Lists the methods used and explain the significance of what has any variants results;
49.10. impact on the total value of the animals (e.g. egg-laying, milk production and reproductive function);
49.11. the number of animals withdrawn prematurely from the studies and reasons for such withdrawal;
49.12. side effects observed characteristics, frequency, and duration;
49.13. additional disease incidence and progress;
49.14. all details concerning medicinal products (other than those which are made in the study), which can be used to test drugs before or simultaneously with them or during the observation period. Details of observed interactions;
49.15. an objective discussion of the results obtained, which allows you to draw conclusions on the safety and efficacy of the product.
50. the general opinion. Provides general opinion on the study and the results of tests made in accordance with annex III and IV of this part. They include an objective discussion of the results obtained, which allows to draw conclusions about the immunological veterinary medicinal product safety and efficacy.
51. Bibliographical references. Detailed records of the bibliographical references cited in paragraph 47 of this annex mentioned in the summary.
Minister of agriculture, the Minister of Interior Or the Ministry of agriculture in Jaundžeikar. submitted in annex 4 of the Cabinet of Ministers of 18 July 2006, the provisions of no. 600 = colouring agents allowed to add veterinary medicinal products 1 2 3 4 no PO box
(E) No International.
Name in English name in Latvian Edition 1 2 3 4 1.
E 100 Curcumin Kurkumīn 2.
E 101 Lactoflavin (Riboflavin) riboflavin 3.
E-102 Tartrazin Tartrazīn 4.
E 104 quinoline yellow Quinolin yellow 5.
E 110 orange yellow S sunset yellow FCF Oranždzelten S sunset yellow FCF 6.
E 120 Cochineal Carminic acid by carmines 7 Ponceau 4R.
E-Carmoisin-122 azorubine Azorubin carmoisine 8.
E 123 amaranth, Amaranth 9.
Cochineal Red A, e 124 Košenilsarkan A Kumač of Poncea 4R 4R is 10.
E 127-11 Eritrozīn Erythrosin.
E 131 patent blue V, the V Patentzil 12.
Indigotin e 132 (Indigo Carmine), indigotine (Indigo Carmine) 13.
(E) the 14.140 Chlorophyllum Chlorophyll
E 141 Copper complex of chlorophyll chlorophyllin to chlorophyllum and and hlorofilīn can be complex, 15.
E Acid brilliant green BS 142 (lissamin green) acid brilliant green BS (lizamīnzaļ) the 16.
Caramel caramel e 150 17.
E 151 brilliant Black BN Black brilliant black BN PN PN 18.
E the vegetal 153 Carb medicinalis (charcoal) medical charcoal (charcoal) 19.
E 160 Carotenoid: carotenoids: 19.1.
E 160 alpha-, beta-, gamma-caroten-alpha-, beta-, gamma-carotene 19.2.
Bixin Norbixin 160b (Annatt of Rouco) bixin norbixin 19.3.
E 160 Capsanthin Capsorubin capsanthin Kapsorubīn 19.4.
E 160d-lycopene Lycopen 19.5.
E 160 beta-APO-8 ' carotenal (C30) Beta-APO-8-karotināl (C30) 12.2.
E 160f Ethyl ester of beta-APO-8-carotenoic acid (C30) ' beta-APO-8-carotenic acid (C30) 20.
E 161 Xanthophyll: Ksantofil: 20.1.
E 161 in Flavoxanthin

Flavoksantīn 20.2.
E 161b Lutein lutein 20.3.
E 161c Kryptoxanthin Kriptoksantīn 20.4.
Rubixanthin Rubiksantīn 20.5 161d e.
E 161 in Violoxanthin Violoksantīn 20.6.
E Rhodoxan Rodoksant in 20.7 to 161f.
E 161 g Canthaxanthin canthaxanthin 21.
(E) the red beet Beetro 162 Betanin red betanin 22.
E 163 anthocyanins in Anthocianin 23.
E 170 calcium carbonate calcium carbonate 24.
E 171 titanium dioxid is titanium dioxide 25.
E 172 Iron oxide and iron oxides and hydroxid hydroxides 26.
E 173 aluminium aluminum 27.
174 e Silver silver 28.
E 175 Gold notes.
1) the General and specific purity criteria for colours that are allowed to add products, as well as methods of analysis used to determine the colours of the compliance with the criteria are identical to those applied to food colours.
2) medicinal products intended for export may be added to the other colours if colours are allowed in the importing country.
Minister of agriculture, the Minister of Interior Or the Ministry of agriculture in Jaundžeikar. the proposed wording of annex 5, the Cabinet of Ministers of 18 July 2006, regulations no 600 registration of veterinary medicinal products, the extension changes the registration dossier for which registration has been submitted, the application for registration, are: 1. changes relating to the active substance (-aj) (s): 1. (-o) of the active substance (s) by a different salt or ester complex or derivatives thereof (with the same therapeutic ingredients) If the exposure and safety characteristics are not significantly different;
1.2. the replacement of the active substance with another isomer or a different mixture of isomers, of a mixture by an isolated isomer (e.g. racemate, replaced with a single enantiomer) where the efficacy and safety characteristics are not significantly different;
1.3. biological or biotechnological product of substance by substance, which is a slightly different molecular structure. Modification of the vector used, as well as the raw material of the Antigen in the manufacture (including new exit (main) cell bank from a different source) if exposure and safety characteristics are not significantly different;
1.4. a new ligand or coupling mechanism for a radiopharmaceutical preparation;
1.5. changes of solvent or ekstraģent herbal medicine plant for if exposure and safety characteristics are not significantly different.
2. changes in the strength of the veterinary medicinal product, form or manner of use: 2.1 changes bioavailability;
2.2. changes in pharmacokinetics (e.g., release the speed grade);
2.3. changes or new strength, as well as adding effects;
2.4. changes or the addition of a new pharmaceutical form;
2.5. usage changes or add new types. If the product enters a parenteral route of Administration indicates (for example, intraarteriāl, intravenous, intramuscular, subcutaneous. Poultry entering the proper way is to use vaccination, oral, respiratory and ocular Administration).
3. other veterinary medicinal products intended for food-producing animals, specific to the target species: a change or addition of target species.
Minister of agriculture, the Minister of Interior Or the Ministry of agriculture in Jaundžeikar. the presented version of annex 6 of the Cabinet of Ministers of 18 July 2006, regulations no 600 small IA and type IB procedure of registration in the register of the national veterinary medicinal products (does not apply to veterinary medicinal products, which recorded the mutual recognition procedure and decentralised procedure) IA and IB type changes are the following: notes.
1) conditions that must be met for specific changes to comply with type IA or type IB procedure specified for each subcategory and listed after each change.
2) at the same time should submit a request for approval for all resulting changes or other changes that may be associated with the changes, for which the request for approval of the change, stating clearly the relation between these changes.
3) notice, which includes a European Pharmacopoeia certificate of suitability, and in cases where the changes apply to the documentation submitted for obtaining this certificate, the necessary documents must be submitted to the European Directorate for the quality of medicines (EDQM). If after the evaluation certificate processing, update all the relevant registration certificate (registration). In many cases this can be done with type IA variations.
4) biological veterinary medicinal product is a product, in which the active substance is a biological substance. Organic substances produced by or extracted from a biological source, and its description and quality make the determination of the physical, chemical and biological tests, as well as control of the production process. Of biological veterinary medicinal products considered the immunological veterinary medicinal product.
5) changes-component protein production process stage due to implementation of biotechnology can be done in accordance with the type I variation 15 or 20. This particular change does not affect other changes listed in this annex, which can be applied to the specific case. This does not apply to the obtained through a biotechnology process introduction of a proteinaceous component of pharmaceutical composition for centralised under the registration of medicinal products covered by the European Commission of 3 June 2003, Regulation (EC) No 1085/2003 concerning the examination of variations of a marketing authorisation for medicinal products for human use and veterinary medicinal products covered by the conditions of the regulation laying down a Community procedure for how to confirm and monitor the medications that are intended for use in human and veterinary medicine and establishing a European Medicines Agency.
6) medicine State Agency does not have to be notified about the update of the European Pharmacopoeia or national pharmacopoeia of a Member State, if compliance with the updated monograph is prepared within six months of its publication and registration of veterinary medicinal products, documentation is a reference to the current version.
referred to in annex 7) in this test method, the same meaning as analytical method and the limit of the same meaning as acceptance criteria.
Minister of agriculture, Minister of Interior of Jaundžeikar.