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The Labelling Of The Veterinary Medicinal Product, Distribution, And Control Rules

Original Language Title: Veterināro zāļu marķēšanas, izplatīšanas un kontroles noteikumi

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Cabinet of Ministers Regulations No. 168 in Riga on 25 March 2004 (pr. Nr. 16, § 20) the labelling of the veterinary medicinal product, distribution, and control rules Issued in accordance with article 5 of the law on Pharmacy 3 and 12 point i. General questions 1. determines: 1.1. procedures shall be marked and distributed in the Republic of Latvia (including imported and exported from the Republic of Latvia) the veterinary medicinal product (including immunological products used for the purpose of determining the level of immunity and active or passive immunity, medicated pre-mixes (any veterinary medicinal product prepared for use, medicated feedingstuffs) and veterinary homeopathic medicinal products);
1.2. the order in which the food and veterinary service controls the distribution of veterinary medicinal products;
1.3. the requirements to be observed when designing instruction on the use of veterinary medicinal products.
2. the rules shall not apply to: 2.1 medicated feedingstuffs;
2.2. the inactivated immunological products, which are manufactured from pathogens and antigens obtained from an animal of a particular farm and used the same farm animal treatment;
2.3. the pharmacy medicinal products manufactured in a specific animal, taking into account the information on the veterinary prescription (line formulas manufactured in pharmacies);
2.4. the pharmacy prepared drugs made in accordance with the prescriptions of a pharmacopoeia;
2.5. in the case of veterinary medicinal products containing radioactive isotopes;
2.6. additives in feedingstuffs.
3. The veterinary medicinal product is authorized to distribute: 3.1 the company (the company) that the food and veterinary service issued a licence for the manufacture of veterinary medicinal products (hereinafter referred to as a manufacturer of veterinary medicinal products). The manufacturer of the veterinary medicinal product by the pharmaceutical law authorized to distribute only veterinary medicinal products manufactured within the specified production licence;
3.2. the company (the company) that the food and veterinary service issued a license to open a health lieltirgotav (operation) (lieltirgotav);
3.3. retail-company (the company) that the food and veterinary service issued a license to open a veterinary pharmacy (operation) (pharmacy);
3.4. Veterinary Law, the person who issued the certificate of veterinary practice.
II. Distribution of veterinary medicinal products, the manufacturer of the veterinary medicinal product is purchased from a person who, in accordance with the pharmaceutical law to distribute medications, if the product is: 4.1 added quality certificate;
4.2 food and veterinary service issued an import permit, if the medicinal product is imported from a country outside the European economic area (European Union, Norway, Iceland or Liechtenstein).
5. the manufacturer of a veterinary medicinal product shall designate the officials responsible in the company (the company). Each officer received and the quantity of veterinary medicinal products issued a detailed records. Records indicate the following information: 5.1. receipt of the veterinary medicinal product or the date of issue;
5.2. name of the veterinary medicinal product;
5.3. assigned serial number and expiration date;
5.4. received or supplied quantities of veterinary medicinal products;
5.5. the veterinary medicinal product, the supplier or the recipient's name and address.
6. the manufacturer of the veterinary medicinal product in these regulations referred to in paragraph 5 records retained for at least three years and records upon request presented to the food and veterinary service officer.
7. the manufacturer of a veterinary medicinal product at least once a year, perform internal audits, comparison of the sent and received shipments of the veterinary medicinal product with the actual inventory items and protokolēj of any non-compliance.
8. Lieltirgotav is permitted: 8.1 to purchase veterinary medicinal products when they are added to the certificate of quality and its distribute person according to the pharmaceutical law have the right to distribute medicine. In the case of veterinary medicinal products imported from a country outside the European economic area, they need food and veterinary service issued the import permit;
8.2. to distribute veterinary drug wholesale (does not apply to the supply of veterinary medicinal products, which make even the manufacturer of the veterinary medicinal product, or to the retail supply of veterinary medicinal products by pharmacies): 8.2.1. only undertakings (companies), which are authorized to engage in the retail supply of veterinary medicinal products;
8.2.2. only physical persons, that the movement of veterinary medicinal products in the laws governing permitted to receive veterinary medicinal products from wholesalers.
9. Lieltirgotav or (if the Department is not in the lieltirgotav of pharmaceutical operations) officer and each received a veterinary medicinal product issued a detailed accounting of the quantity. Records indicate the following information: 9.1 the veterinary medicinal product, and the date of issue of the receipt;
9.2. name of the veterinary medicinal product;
9.3. the manufacturer of a veterinary medicinal product granted a veterinary medicinal product serial number and date of expiry;
9.4. the received or issued quantities of veterinary medicinal products;
9.5. the veterinary medicinal product, the supplier or the recipient's name and address;
9.6. an individual's name, address and request number if lieltirgotav or its Department of veterinary medicinal products shall be issued to the person served in a veterinary practice certificate.
10. Lieltirgotav and these rules in Chapter 9, paragraph records and requests for veterinary medicinal products shall keep for at least three years and records upon request presented to the food and veterinary service officer.
11. Lieltirgotav and its chapter at least once a year, perform internal audits, comparison of the sent and received shipments of the veterinary medicinal product with the actual inventory items and protokolēj of any non-compliance.
12. The retail supply of veterinary medicinal products (sale of goods in small quantities directly to the consumer) in Pharmacy and its affiliates.
13. Pharmacy is permitted to purchase veterinary medicines under the pharmaceutical Act.
14. The Pharmacy and drugstore Executive Branch received and issued detailed records for veterinary medicinal products.
15. The Pharmacy and drugstore branch person in charge for the received a veterinary medicinal product, the following information shall be recorded: 15.1 the receipt date;
15.2. name of the veterinary medicinal product and the name of the manufacturer of the veterinary medicinal product;
15.3. the manufacturer of a veterinary medicinal product for veterinary medicinal products that are assigned a serial number;
15.4. the received quantity of veterinary medicinal products;
15.5. the supplier's name and address.
16. Pharmacy officer for the received or issued the prescription medicinal products, veterinary medicinal products intended for food-producing animals, and for veterinary medicinal products, which use must follow the withdrawal time, record the following information: 16.1 medicine receipt or date of issue;
16.2. name of the veterinary medicinal product and the name of the manufacturer of the veterinary medicinal product;
16.3. the manufacturer of a veterinary medicinal product for veterinary medicinal products that are assigned a serial number;
16.4. the received or issued quantities of veterinary medicinal products;
16.5. If issued prescription veterinary drug, the name and address of the official veterinarian who issued the prescription.
17. In the case of veterinary medicinal products shall be issued against the prescription, pharmacies, the responsible person shall keep for at least three years the recipes first.
18. The Pharmacy and drugstore branch at least once a year, perform internal audits, comparison of the statements and received quantities of veterinary medicinal products, with the actual inventory items and protokolēj of any non-compliance.
19. The Pharmacy and drugstore branch this provision 14 records referred to in paragraph shall keep for at least three years and records upon request presented to the food and veterinary service officer.
20. Another Member State of the European Union by a veterinarian authorised to import into the Republic of Latvia ready for veterinary medicinal products in small quantities not exceeding one day use of the veterinary medicinal product, and use it to animals (other than immunological products which are prohibited in the Republic of Latvia), if: 20.1. the competent body of the Member State in which the veterinarian established his professional activity, has issued a special permit (licence) or certificate of veterinary practices;
20.2. the veterinarian veterinary medicinal products carried in the manufacturer's original packaging;
20.3. in the case of veterinary medicinal products intended for use in animals from which the foodstuffs of animal origin (productive animals), has the same qualitative and quantitative composition in active substances as veterinary medicinal products that are authorised for use in food-producing animals in the Republic of Latvia;
20.4. the veterinarian familiar with veterinary practices in the Republic of Latvia and the duration shall ensure compliance with the withdrawal period for veterinary medicinal products specified in the labelling of the veterinary medicinal product or in the instructions for use. If the Republic of Latvia the relevant veterinary medicinal products set a longer withdrawal period, the veterinarian should be followed;
20.5. the veterinarian shall not be issued in the Republic of Latvia to treat the animal owner or holder in veterinary medicinal products, with the exception of the minimum quantities of veterinary medicinal products that are required for a particular course of treatment of the animal;

20.6. the veterinarian shall maintain detailed records showing the information of the animals treated, the diagnosis, the medicinal products, their doses and duration of treatment. Records retained for at least three years. The records and the veterinary medicinal product is presented after the first request of the food and veterinary service officer;
20.7. this rule 20.6. accounting referred to in subparagraph shall also determine the withdrawal period for veterinary medicinal products, if the treated animals to productive.
21. in order to protect human and animal health, the following shall be issued against the prescription of veterinary medicinal products: 21.1. products subject to distribution (including delivery) or usage limits: 21.1.1.30 March 1961 Single Convention on narcotic substances and the 1972 Protocol amending the 1961 Single Convention of 30 March on narcotic substances;
21.1.2. the law on restrictions on the use of the medicinal product;
21.2. the use of drugs which the veterinarian observe extreme caution, since they can be dangerous: 21.2.1. the species of animal for which the veterinary medicinal product is intended;
21.2.2. the person administering the veterinary medicinal product to animals;
21.2.3. the person who consumes food products derived from treated animals;
21.2.4. environment;
21.3. medicines used in the pathological process and, if the precise diagnosis. Otherwise, the veterinary medicinal product may cause effects which impede or interfere with diagnostic or therapeutic actions of the veterinary medicinal product;
21.4. the medicinal product which is prepared in a pharmacy in the veterinarian's prescription for an individual animal;
21.5. the medicinal products containing active substances in the manufacture of veterinary medicinal products are used in less than five years. These drugs without a prescription is issued, if the food and veterinary service, assessing application (for registration of veterinary medicinal products) supplied information and data or experience gained in practice, the use of the medicinal product obtains assurance that none of these provisions 21.1 21.2 21.3 21.4., and the criteria referred to in (a);
21.6. medicinal products instructions for use is "authorized to distribute to pharmacies licensed veterinary prescription".
22. Natural persons crossing the State border, together with the animal may be imported and exported animals for veterinary medicinal products intended for the treatment, not exceeding two months. The need for the veterinary medicinal product proves, by presenting a veterinary prescription, prescription copy or other proof of this fact.
III. Arrangements for the distribution of veterinary medicinal products that have anabolic, antimicrobial, anti-parasitic, anti-inflammatory, hormonal or psychotropic action 23. Veterinary medicinal products or active substances (used as veterinary medicinal products) that have anabolic, antimicrobial, anti-parasitic, anti-inflammatory, hormonal or psychotropic action, distributed in accordance with the procedure laid down in these provisions.
24. the manufacturer of a veterinary medicinal product, and its lieltirgotav Division, which distributes active substances or veterinary drugs with psychotropic action, shall keep records in accordance with the laws and regulations governing psychotropic and narcotic drug. The manufacturer of the veterinary medicinal product, and its lieltirgotav Division, which distributes active substances or veterinary medicinal products with anabolic, antimicrobial, anti-parasitic, anti-inflammatory, hormonal activity or maintain accurate records: 24.1. showing all transactions with the relevant veterinary medicinal products and substances;
24.2. stored for at least three years after the last entry.
15.1. where the request is presented by the food and veterinary service officer.
25. the owner or keeper of the animals that use veterinary medicinal products that have anabolic, antimicrobial, anti-parasitic, anti-inflammatory, hormonal activity or animal (animal group) obtained from foodstuffs of animal origin, for at least three years (even if treated animals during that time have already been slaughtered) Save: 25.1. purchase of the veterinary medicinal product concerned documents that include the drug buyer's first name and last name;
25.2. the registry or tracking log for the appropriate use of veterinary medicinal products for animals.
26. Rule 25.2. the register referred to in subparagraph or accounting log indicates the following: 26.1. date on the use of veterinary medicinal products;
26.2. name of the veterinary medicinal product;
26.3.;
26.4. the veterinary medicinal product, the supplier's name or the first name, surname and address;
26.5. identification number of the animal for which the veterinary medicinal product is used.
27. Rule 25.2. the register referred to in point or accounting magazines on request presented to the food and veterinary service officer.
IV. Procedures stored for distribution for veterinary medicine veterinary medicine 28. manufacturer provides storage space for veterinary medicinal products, which can ensure the storage separately from packaging materials, raw materials, intermediate products or ready-made veterinary medicinal products which have been withdrawn, rejected or been returned are subject to quarantine.
29. the provisions referred to in paragraph 28 of the rooms is easy to clean, dry, ventilated. Indoor lighting and temperature to ensure appropriate labelling requirements, and for this purpose, use the automatic action of temperature and humidity measuring device.
30. The quarantine zone (zone the storage of veterinary medicinal products, the distribution of which is suspended until final clarification of the circumstances, if there is suspicion of movement of veterinary medicinal products regulatory breaches the laws) is separated from the other rooms or room parts. The quarantine area marked "quarantine area" and ensure that it does not penetrate the outsiders.
31. atpakaļatsūtīt, or reject the storage of a veterinary medicinal product shall ensure deflection or room part.
32. The veterinary medicinal product is placed on the storage pallets made of material which is easy to clean and disinfect.
33. Lieltirgotav and its chapters are: 33.1. rooms or enclosed space: 33.1.1. the adoption of the veterinary medicinal product;
33.1.2. storage of the veterinary medicinal product;
33.1.3. the issue of the veterinary medicinal product;
33.1.4. intended for destruction, undo, atpakaļatsūtīt or reject or quarantine of veterinary medicinal products for the storage of veterinary medicinal products. Subject to quarantine medicine and from the others by a suitably labelled;
33.2. a separate room for staff;
33.3. sanitary knot.
34. in paragraph 33 of the rules of that space is easy to clean, dry, ventilated and lit accordingly.
35. Lieltirgotav and its departments of the veterinary medicinal product storage space provided by: 21.8. the labelling of the veterinary medicinal product and in the operating instructions for the specified storage conditions, a specific temperature, humidity and lighting;
35.2. easy to clean and disinfect equipment;
35.3. the storage of certain veterinary medicinal products, having regard to the Group of veterinary medicinal products and series;
35.4. to avoid damage to the packaging of the veterinary medicinal product and avoid cross contamination of the veterinary medicinal product;
22.1. the temperature and humidity control. Temperature and humidity measurements recorded at least once a day;
35.6. the placing of veterinary medicinal products on the shelves or pallets made of material which is easy to clean and disinfect.
36. If the veterinary medicinal product, the storage required for a specific temperature, storage room or equipment is equipment that captures any deviation from the intended temperature.
37. The Pharmacy and its subsidiaries are interconnected, enclosed rooms or parts of rooms: 37.1. the veterinary medicinal product;
37.2. the storage of veterinary medicinal products. This room or room part provides a protected area for disposal of containers of parts or design is not valid in the case of veterinary medicinal products;
37.3. personnel and sanitary knot.
38. paragraph 37 of the rules of the premises in question prohibited hold and treat the animals, as well as to engage in activities that are not related to the distribution of veterinary medicinal products.
39. Rule 37.2. room referred to in point or part of the supports: 24.3. placing veterinary medicinal products on the shelves or pallets;
24.4. the labelling of the veterinary medicinal product in storage conditions, a specific temperature, humidity and lighting;
39.3. easy cleaning of the space conditions, easy to clean and disinfect equipment;
24.5. the storage of certain veterinary medicinal products, having regard to the Group of veterinary medicinal products and series;
24.5. to avoid damage to the packaging of the veterinary medicinal product and avoid cross contamination of the veterinary medicinal product.
40. persons covered by veterinary practice certificate (hereinafter the veterinarian), the veterinary medicinal product is kept in movement of veterinary medicinal products regulatory legislation.
41. Disseminating (including transport) and storing the veterinary medicinal product, provides: 41.1. the labelling of the veterinary medicinal product specified conditions — the appropriate lighting and humidity;
41.2. the labelling of the veterinary medicinal product contains temperature: 41.2.1. at room temperature (15 – 25 ° C);
41.2.2. cool site (8-15 ° C);
41.2.3. cold (2-8 ° C);
41.3. equipment that captures any deviation from the intended temperature mode, if the transport time of the veterinary medicinal product needs a certain temperature;
25.7. to avoid damage to the packaging of the veterinary medicinal product and avoid cross contamination of the veterinary medicinal product, as well as to climatic or other factors do not affect veterinary medicinal products;

25.8. notarized veterinary medicine production license, a copy of the delivery to another Member State of the European Union veterinary medicinal products provided that the territory of the Republic of Latvia from a country outside the European economic area.
V. Veterinary medicinal products which are prohibited to distribute 42. it shall be prohibited to distribute: 42.1. veterinary pharmaceuticals in the cases referred to in the law;
26.2. veterinary medicinal products which are not clear, damaged, these rules do not match the label;
26.3. veterinary medicinal products which is not added to the food and veterinary service confirmed the national instruction language;
26.3. to the recipe — products and other immunological veterinary medicinal products which may, in accordance with the movement of veterinary medicinal products regulatory legislative requirements may only enter animal veterinarian.
43. The food and veterinary service may prohibit importation of veterinary immunological products and distribution (including delivery) throughout the territory of the Republic of Latvia or its part if: the use of the said products 26.8. makes: disease diagnosis 43.1.1., control and eradication, eradication and control of which is in accordance with the national infectious disease eradication programme;
43.1.2. opinion on the contamination of animals;
43.1.3. opinion on animal food products derived from vaccinated animals;
43.2. throughout the territory of the Republic of Latvia or its part is not present the disease against which the veterinary immunological products leads to immunity.
44. The food and veterinary service shall inform the Commission of cases in which it prohibits importation of veterinary immunological products, distribution and production throughout the territory of the Republic of Latvia.
45. The destruction of poor quality veterinary medicinal products surrendered for destruction in the movement of hazardous waste regulations governing order, before doing the tracking. Records indicate the following information on the destruction of all the invalid provided for veterinary medicinal products: 45.1. name;
45.2. serial number;
45.3.;
28.2. type of packaging.
Vi. Requirements for the labelling of the veterinary medicinal product and the instructions on the medicine container for 46. or or primary packaging secondary packaging clearly legible letters the following information (approved by recording the veterinary drug in food and veterinary service): 46.1. name of the veterinary medicinal product. The name can be: 46.1.1. brand name together with a trade mark or name of the manufacturer of the veterinary medicinal product;
46.1.2. non-proprietary name of the veterinary medicinal product, together with a trade mark or name of the manufacturer of the veterinary medicinal product;
46.1.3. a scientific name or formula, with or name of the manufacturer of the veterinary medicinal product or without it;
46.1.4. The World Health Organization recommended international non-proprietary name (any active substances or the name of the finished medicinal product which is not protected by patent, copyright, trademark, or other means), if the trademark is the special name of the veterinary medicinal product containing only one active substance. If the name does not exist, the usual non-proprietary name assigned;
46.2. the veterinary medicinal product, qualitative and quantitative composition in active substances in one dose or veterinary medicinal products according to the use of veterinary medicinal products, veterinary medicinal products, volume or weight. Active substance names are specified using the World Health Organization international non-proprietary names recommended by the, but if this name do not constitute non-proprietary names;
46.3. the veterinary medicinal product, the manufacturer assigned serial number;
46.4. the registration of veterinary medicinal products, authorization number;
46.5. the registration certificate of the veterinary medicinal product by the holder (owner) and the manufacturer of the veterinary medicinal product (if different) name and business address;
46.6. the species of animal for which the veterinary medicinal product is intended, the dosage for the veterinary medicinal product, method, route and date of expiry;
29.0. the withdrawal period for veterinary medicinal products. The withdrawal period is required to specify the veterinary medicinal products intended for food-producing animals. The withdrawal period indicated even if this is nil;
29.1. the guidelines for the storage of medicinal products for veterinary use, or unused veterinary medicinal products and their waste disposal (if any);
46.9. references: 46.9.1. "use of animals";
46.9.2. veterinary homeopathic medicinal products-' veterinary homeopathic medicinal products "and" consult with a veterinarian in case of veterinary homeopathic medicinal products cause side effects ";
46.10. other important health and safety information (if any) that you have requested the food and veterinary service, or the national competent authority;
46.11. Republic of Latvia izplatāmaj veterinary medicinal products (separate box) — the registration number of the Latvian register of veterinary medicinal product and the indication "recipe", if they are registered as a prescription medicine.
47. The veterinary medicinal product, the form and content of units of mass or volume or dose Unit indicates only the secondary package.
48. these provisions 46 ampoules. the information referred to in paragraph 1 points to the secondary packaging.
49. On the ampoules indicates the following: 49.1. name of the veterinary medicinal product;
30.6. the quantities of active substances;
30.6. the route of administration;
49. the manufacturer of a veterinary medicinal product for veterinary medicinal products that are assigned a serial number;
30.8. expiration date;
30.8. "use of animals".
50. If the primary packaging (except ampoules) is only one dose of the veterinary medicinal product and it is not possible to deploy these rules 46 and 47. information referred to in paragraph 1, the relevant information indicates the secondary packaging.
51. If the veterinary medicinal product is not a secondary packaging, 46 and 47 of these provisions the information referred to in paragraph indicates the primary packaging.
52. the information specified in the instructions for use must be in accordance with the registration of veterinary medicinal products, the information specified in the documents.
53. food and veterinary service, registration of veterinary medicinal products, approves the operating instructions in the language of the country.
54. The instructions shall specify the following information: 54.1. the registration certificate of the veterinary medicinal product by the holder (owner) and the manufacturer of the veterinary medicinal product (if different) name and business address;
54.2. name of the veterinary medicinal product and the World Health Organization recommended international non-proprietary name (if any);
54.3. the veterinary medicinal product, qualitative and quantitative composition in active substances and the therapeutic indications;
54.4. the contraindications and possible side effects;
54.5. the species of animal for which the veterinary medicinal product is intended, the dosage for each species, the method of use, the type and, if necessary, instructions for the proper use of the veterinary medicinal product;
54.6. the withdrawal period for veterinary medicinal products (specify the veterinary medicinal products intended for food-producing animals). The withdrawal period for veterinary medicinal products shall be indicated even if this is nil;
54.7. instructions for the storage of medicinal products for veterinary use, or unused veterinary medicinal products and their waste disposal (if any);
54.8. other important health and safety information, which required a food and veterinary service or other competent national authority (if any);
54.9. "be distributed to pharmacies licensed veterinary prescription", if the veterinary medicinal product is authorized to distribute to the recipe.
55. the instructions for use included in the packaging of veterinary medicinal products shall be obligatory unless the instructions appearing on the information conveyed on the primary and secondary packaging. Operating instructions only apply to the veterinary medicinal product with which it is included.
56. National language provides the following information: 56.1. the labelling of veterinary medicinal products, the information referred to in this provision, 29.0 29.0 29.1 and 46.9, in;
56.2. ampoule labelling information referred to in this provision and in paragraph 30.6 30.8..
57. Veterinary homeopathic medicinal products, which is not a formal therapeutic indications, instructions indicating the following information: 57.1. raw materials or scientific name;
57.2. veterinary medicinal dilution factor (specified using the symbols of the pharmacopoeia);
57.3. the registration certificate of the veterinary medicinal product by the holder (owner) and the manufacturer of the veterinary medicinal product (if different) name and business address;
57.4. method of application and, if necessary, the route of administration;
57.5. the exact expiration date (month and year);
57.6. pharmaceutical form and instructions for storage or for use (if any);
57.7. the species of animal for which the veterinary medicinal product is intended;
57.8. veterinary medicinal products, the manufacturer of veterinary zāļusērij granted number and registration number of the veterinary medicinal product;
57.9. veterinary homeopathic medicinal products with the information contained in annotations and warnings about the use of homeopathic veterinary medicinal products (if any are needed).
58. the labelling of the veterinary medicinal product package contents of adequacy is the responsibility of the veterinary medicinal product manufacturer that the veterinary medical product is manufactured or packaged again.
VII. parallel imports of veterinary medicinal products in

59. The parallel imported medicinal products for veterinary use (veterinary medicinal products registered by the national registration procedures in any of the countries belonging to the European economic area, which are exported to another country within the European economic area and which are imported by a person other than the veterinary medicinal product, the holder of the registration certificate (the owner) or a manufacturer of veterinary medicinal products): 59.1. are identical with the Republic of Latvia registered veterinary medicinal composition, form, and therapeutic effect. Permitted small parallel imported veterinary medicinal products the composition of excipients, or colouring agents colouring agent code differences between the Republic of Latvia has already established the composition of the veterinary medicinal product;
59.2. destined for no longer than the corresponding in the Republic of Latvia registered veterinary medicinal products.
60. The veterinary medicinal product may be imported in parallel only in the lieltirgotav, which the food and veterinary service has received the authorisation of veterinary medicinal products, parallel imports.
61. the rules referred to in paragraph 60 of the permit is issued if the applicant for authorization shall be submitted to the food and veterinary service of the document which shall include the following documents and information: 61.1. application for parallel imports of veterinary medicinal products (for each parallel to the name of the medicinal product to be imported);
61.2. parallel to the name of the veterinary medicinal product to be imported and the country where they are produced;
38.1. the parallel imported medicinal products for veterinary use the registration number of the exporting country, veterinary medicinal products, the holder of the registration certificate (the owner) and the name of the manufacturer of the veterinary medicinal product;
61.4. According to the Republic of Latvia, the registered name of the veterinary medicinal product and the registration number of the Latvian register of veterinary medicinal products;
61.5. the competent authorities of the exporting country, approved the use of veterinary medicinal products a copy of the instruction in the language of the country in which the medicinal product is manufactured;
61.6. parallel imports of medicinal products for veterinary use intended for translation into Latvian language of instruction in accordance with the requirements of these provisions and the declaration certifying that the translation corresponds to the information given in the country of a veterinary medicinal product authorised in the instructions for use;
38.3. the parallel distribution of veterinary medicinal products intended for a sample of the Latvian language labelling and declaration certifying that the information given on the label is identical to the importing country if the registered veterinary medicinal products approved in the labelling particulars, except the following information: the identity of the importer 61.7.1. who makes parallel imports;
61.7.2. another medicinal product manufacturer (if different);
61.7.3. differences in the stability of the veterinary medicinal product;
61.7.4. differences in the excipient of the veterinary medicinal product (dyes) (if any);
38.4. veterinary medicinal products mock-ups or samples of the natural size of the exporting country;
61.9. in the case of veterinary medicinal products mock-ups or samples in natural size, intended for import.
62. If lieltirgotav again packaged or labelled repeatedly parallel imported medicinal product, it shall be submitted to the food and veterinary service: 62.1. veterinary medicinal products mock-ups in natural size.
62.2. a declaration that the composition of the veterinary medicinal product is not changed;
38.7. manufacture of veterinary medicinal products a copy of the license;
38.8. documents that prove that the manufacturer of a veterinary medicinal product authorized to take such actions with the parallel imported medicinal product.
63. Lieltirgotav to repeatedly and repeatedly marķētaj the packaged parallel imported medicinal products: 39.2. original serial number in brackets behind it — the new serial number;
39.3. parallel importing of veterinary medicinal products imported;
63.3. veterinary medicinal product imported in parallel of the repeating of the packer;
63.4. in parallel, a manufacturer of veterinary medicinal products imported.
64. Forbidden to specify the competent authority of the country in which the approved indications for medicinal products, if they have not been confirmed in the Republic of Latvia.
65. The food and veterinary service consumption: 65.1. lieltirgotav list, which allowed to make parallel imports of veterinary medicinal products;
65.2. the parallel imported medicinal product list.
66. The food and veterinary service: 66.1. check that the information in documents submitted to the veterinary medicinal product, the parallel import authorisation, is true. If this information is not true, the permission shall not be issued;
66.2. evaluated in parallel import veterinary medicinal products for compliance with the Latvian register of veterinary medicinal products in the respective products;
66.3. shall issue a certificate of the veterinary medicinal product, if parallel imports parallel imported medicinal product meets the requirements of this regulation. The certificate shall be issued for a period not exceeding the relevant Latvian veterinary medicinal products registered in the registration, the period of validity of the licence. A certificate of veterinary medicinal products, parallel imports shall be drawn up in accordance with the laws and regulations that govern the registration of veterinary medicinal products;
66.4. Decides on the authorization of veterinary medicinal products, parallel imports or the refusal to issue it. The decision shall be taken within 30 days from the date of the food and veterinary service has received the application and this provision paragraph 61 of that document as a whole;
41.3. inform in writing the applicant if additional information is needed to assess whether parallel import veterinary medicinal product and the corresponding Latvian register of veterinary medicinal products include medicines produced using the same production formula.
67. Lieltirgotav, which allowed to make parallel imports of veterinary medicinal products: 67.1. nutrition data system, which provide information on activities relating to the importation of medicinal products imported in parallel. The data in the system specifies the identity of the veterinary medicinal product imported, produced, serial number, and the amount of the imported series;
67.2. Latvia shall inform the relevant veterinary medicinal product on the register registration certificate holder (owner) or relevant representations accredited in the Republic of Latvia on the parallel distribution of veterinary medicinal products imported into the opening of the Republic of Latvia;
67.3. two weeks after the food and veterinary service of receipt of the request, provide information about transactions with parallel imported medicinal products;
41.9. two weeks submit a food and veterinary service additional information if that has changed the rules of the information referred to in paragraph 61.
68. The food and veterinary service shall withdraw the authorisation of veterinary medicinal products, parallel imports and of the decision taken (the basis) in writing notify the veterinary drug parallel import authorisation holder (holder) if: 68.1. This has changed the rules referred to in paragraph 61 the information related to the quality of veterinary medicinal products or quantitative composition or therapeutic effect, but the food and veterinary service is not informed about it;
68.2. irregularities in the distribution of medicines.
VIII. dissemination of the veterinary medicinal product control 69. distribution of veterinary medicinal products (including import and export in the Republic of Latvia from its) compliance with the movement of veterinary medicinal products regulations governing supervision and control of the food and veterinary service.
70. The food and veterinary service consists, in the case of veterinary medicinal products, the manufacturer of lieltirgotav and pharmacies, which are allowed to distribute or use in the production of active substances or veterinary medicinal products with anabolic, antimicrobial, anti-parasitic, anti-inflammatory, hormonal or psychotropic action.
71. a food and veterinary service shall take all necessary measures to ensure that imports of veterinary medicinal products and to prevent the proliferation, as well as suspend or revoke the certificate of registration of veterinary medicinal products, pharmaceutical law case referred to in article 31.
72. a food and veterinary service bans the supply and withdraw excess veterinary medicine and veterinary medicine series: 72.1. veterinary medicinal products considered harmful or dangerous, it is used to match the information that the veterinary medicinal product, the holder of the registration certificate (the owner) pointed out the documents of the registration certificate of the veterinary medicinal product, or if the veterinary medicinal product, the holder of the registration certificate (the owner) is not informed by the food and veterinary service on amendments to the registration documents of the veterinary medicinal product;
72.2. the veterinary medicinal product has no therapeutic effect on the species of animal for which the treatment was intended;
72.3. the veterinary medicinal product, qualitative and quantitative composition is not registration documents specified;
72.4. registration of veterinary medicinal products the documents specified a period in which the veterinary medicinal product is released from the organism, the animals are not long enough to get from animals treated foodstuffs do not contain residues of veterinary medicinal products, which can be a health hazard to the consumer;
72.5. manufacture of the veterinary medicinal product or imports from countries outside the European economic area does not match the movement of veterinary medicinal products in the laws governing the requirements or if quality control of veterinary medicinal products, the manufacturer of enterprise (company) or manufacture of the veterinary medicinal product does not correspond to the documents that the manufacturer of a veterinary medicinal product submitted by the food and veterinary service of the veterinary medicinal product in production licence;
72.6 at. veterinary medicinal products, labelling or the package leaflet do not comply with the requirements of this regulation;
72.7. veterinary medicinal products are distributed by specifying the use of the veterinary medicinal product, which is prohibited under the regulations;

72.8. the information provided in the documents of the veterinary medicinal product registration certificate is false;
45.3. the veterinary medicinal product is not added to the contrast medium, if any are defined in the add the registration certificate of the veterinary medicinal product.
73. The food and veterinary service shall ensure cooperation with other competent authorities, particularly in matters affecting the movement of veterinary medicinal products in the laws governing the requirements relating to: 73.1 (3) these rules. in these licenses;
73.2. in the Republic of Latvia and other Member States of the European Union produced and distributed a homeopathic veterinary medicinal product quality and safety.
74. a food and veterinary service may request information from a manufacturer of veterinary medicinal products in the European Union, the competent authorities of the Member State, if the chain found high-quality veterinary medicine. If the food and Veterinary Office of the European Union decision of the competent authority of the Member State are unacceptable, it shall inform the competent authority of their objections or requests additional information. If necessary, the food and veterinary service shall also inform the Commission if there is a significant difference between the point of view of food and veterinary service and other European Union Member State competent authority.
75. The food and veterinary service shall inform without delay the European Medicines Agency (hereinafter Agency) such decisions (including their grounds): 75.1. the special permit (license) issued the rule in paragraph 3, the following companies (companies);
75.2. the refusal to issue a special permit (license) this provision in paragraph 3, the following companies (companies);
75.3. This provision is referred to in paragraph 3, the special permission (license) is annulled;
75.4. distribution of veterinary medicinal products (including delivery) restricting;
75.5. veterinary medicinal products from the chain.
76. the distribution of veterinary medicinal products, suspension or withdrawal, arguing such action, the registration certificate of the veterinary medicinal product holder (owner) reported to the food and veterinary service and other European Union Member States in which the veterinary medicinal product is distributed.
77. a food and veterinary service shall inform the Agency if: this rule 76 77.1. the operations referred to in paragraph related to the lack of efficacy of the veterinary medicinal product or the protection of public health, or in the Republic of Latvia and other Member States of the European Union produce and distribute a homeopathic veterinary medicinal product quality and safety;
77.2.74. these rules and paragraph 75 of the activities referred to are aware of the other international organizations working in the field of veterinārfarmaceitisk.
78. a food and veterinary service of the exporting country by the veterinary medicinal product or the importing country-a country which is not part of the European economic area — at the request of the competent authority shall certify that the manufacturer of the veterinary medicinal product, which the veterinary medicinal product is exported, the manufacturing authorization.
79. With this provision of the proof referred to in paragraph 78 of document food and veterinary service issued a summary description of veterinary medicinal products intended for export and which are allowed to be distributed in the territory of the Republic of Latvia, but, failing that, an equivalent document.
80. the manufacturer of the veterinary medicinal product, who wants to get that rule 78 the proof referred to in paragraph but does not have permission to distribute veterinary medicinal products on the territory of the Republic of Latvia, providing food and veterinary service explanation of why no such authorization.
81. If food and veterinary service suspended or cancelled by the provisions referred to in paragraph 3 of the authorisation it shall publish the relevant information in the newspaper "journal".
IX. final question 82. provisions shall enter into force on 1 May 2004.
Informative reference to European Union Directive provisions included in the law arising from Directive 2001/82/EC.
Prime Minister, Minister of defence (A) the Minister of Agriculture Slakter. M. rose Editorial Note: rules shall enter into force on 1 May 2004.