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Amendments To The Cabinet Of Ministers On 19 June 2007 The Provisions Of No. 407 "the Labelling Of The Veterinary Medicinal Product, Distribution, And Control Rules"

Original Language Title: Grozījumi Ministru kabineta 2007.gada 19.jūnija noteikumos Nr.407 "Veterināro zāļu marķēšanas, izplatīšanas un kontroles noteikumi"

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Cabinet of Ministers Regulations No. 1394 in Riga 2009. on 8 December (pr. No 87 40) amendments to the Cabinet of Ministers on 19 June 2007 the provisions of no. 407 "labelling of the veterinary medicinal product, distribution, and control rules" Issued in accordance with article 5 of the law on Pharmacy 3 and paragraph 12, the first subparagraph of article 48 to make the Cabinet of 19 June 2007 the Regulation No 407 "labelling of the veterinary medicinal product, distribution, and control rules" (Latvian journal, 2007, 100 no) the following amendments: 1. delete the reference to which the provisions of the basic law issued , words and numbers "and the law" on the illicit manufacture of narcotic drugs and psychotropic substances and to the legitimate movement of medicinal products order "article 37 1 and 2".
2. Replace the text, the words "the State Pharmaceutical inspection" (fold) with the words "health inspection" (fold).
3. Delete paragraph 1.1., the words "(including medicines containing controlled drugs in Latvia and psychotropic substances list II substances (narcotic drugs) and (iii) the list of substances (hereinafter referred to as psychotropic drugs))".
4. Delete the second sentence of paragraph 5.2.
5. Make the introductory paragraph 9 by the following: "9. in the Lieltirgotav, and the importer is entitled:".
6. Delete paragraph 9.2.3, second sentence, the words "affiliates".
7. Delete paragraph 9.2.4.
8. Supplement with 9.3. subparagraph by the following: "9.3. distribute medicated premixes for animal feed business establishments that manufacture medicated feed and are recognised in food and veterinary services in accordance with the legislation on animal feed business and recognition of business registration procedures."
9. Supplement with 9.1, 9.2, 9.3 and 9.4 points as follows: 9.1 Lieltirgotav "is entitled to distribute veterinary medicine (veterinary education and science institutions) and persons who do not deal with veterinary practices, but purchased the veterinary medicinal product is their actions, if these institutions and persons food and veterinary service according to the rules laid down in chapter III of the requirements has allowed to purchase veterinary medicinal products (hereinafter referred to as the recipient of the permit). Information on the permissions available to the recipients of the food and veterinary service home page on the internet that you inserted into the list of the beneficiary of the authorisation (hereinafter list).
9.2 the responsibilities of the beneficiary of the authorisation: 9.2 1. enter into a contract with practicing veterinarians or veterinary care merchants (hereinafter referred to as a practicing veterinarian responsible) for the movement of veterinary medicinal products. Contract with veterinary care merchant separately State the name of the veterinarian and veterinary practice certificate number that permits the company to constantly take action with the veterinary medicinal product;
9.2 2. to promote responsible veterinarian practicing in action, passing it the required space and does not hinder practicing veterinarian in charge of the permanent obligation;
9.2 3. ensure the movement of veterinary medicinal products in accordance with company regulations, arrangements for persons engaged in veterinary practice, acquired, stored and used in medicine;
9.2. ensure quality 4 veterinary medicinal products and veterinary medicinal products used for the destruction of primary packaging according to the legislation on waste management;
9.2 5. ensure that the veterinary medicinal product, storage facilities and drug chain documentation is available from the food and veterinary service officer;
9.2 6. within five working days after the event to inform the food and veterinary service about: 9.2 6.1. authorization of the recipient name or change of address;
9.2 6.2. herd or shed, changing the registration number;
9.2. the responsible veterinarian practicing 6.3 change or the responsible veterinarian practicing veterinary practice certificate number.
9.3 the responsible veterinarian practicing permission requested in veterinary drug company records, stored, used and discarded, or poor quality drugs destroyed in accordance with the movement of veterinary medicinal products regulatory laws and requirements.
9.4 responsible practicing veterinarian statement demand the purchase of veterinary medicinal lieltirgotav. The request includes: 9.4 1. name, address, telephone number, electronic mail address;
9.4. the responsible practitioner 2 veterinarian's name and certificate number of the veterinary practice;
9.4 3. date on which the beneficiary of the authorization included in the list, and the number in the list;
9.4 4. name of the medicinal product, shape, strength and quantity;
9.4 5. veterinary practice certificate stamp if the request is not made in electronic form of the document, date, as well as the responsible official veterinarian signature of medical practitioner. "
10. Express 10. the introductory part of the paragraph by the following: ' 10. Lieltirgotav provides the following requirements are met: ".
11. Supplement with 10.4.6 and 10.4.7. subparagraph such.: "10.4.6. an individual's name, address and certificate number of the veterinary practice where the veterinary medicinal product issued by a practicing veterinarian;
10.4.7. name, address and on the movement of veterinary medicinal products, the practitioner responsible for the veterinarian's name and certificate number, as well as those issued by the official veterinarian of the veterinary medicinal product demand, if the veterinary medicinal product issued by veterinary care or permission of the recipient operators. "
12. Delete paragraphs 11 and 12.
13. Make introductions to paragraph 13 and 13.1. subparagraph by the following: ' 13. importers and lieltirgotav: 13.1. This provision 10. information referred to in paragraph 1 and request veterinary medicinal products shall be stored for not less than three years and shall, on request, be produced to the Inspector of the health inspection. Health inspection immediately by telephone or electronically inform the food and veterinary service of the irregularities detected in the operation of the lieltirgotav, if this violation may be compromised due to human or animal health. "
14. Add to paragraph 13.3. beyond words "at any time" with the words "and presented with the movement of medicinal products related documents".
15. The deletion of the introductory part of paragraph 14, the words "as well as its affiliates".
16. Make the title of chapter III, the following: "(iii). The order in which the food and veterinary service of the veterinary medicinal product is authorized for purchase".
17. Express 17, 18 and 19 of the following paragraph: "17. to receive permission for the purchase of veterinary medicinal products, the rules referred to in paragraph 9.1 authority or person: 17.1. Food and veterinary service of the application. The application shall state: 17.1.1. the name, address, telephone number, email address or fax number, the actual site address, if different from the registered office;
17.1.2. veterinary care the operator's name, address and a practicing veterinarian's name and certificate number of the veterinary practice that constantly perform actions on veterinary medicinal products, where this provision 9.2 1. contract referred to the veterinary care of economic operators;
17.1.3. the responsible practitioner of the veterinarian and veterinary practice certificate number if this provision 9.2 1. referred to in the contract concluded with the practicing veterinarian;
17.1.4. This provision 9.2 1. referred to contract period;
17.1.5. the justification of the need for the procurement of veterinary medicinal products, by practicing whereof the responsible official veterinarian the signature and the imprint of the stamp of the veterinary practice;
17.2. bear with the actual site inspection expenses in accordance with the laws and regulations of the food and veterinary service to the public provided by the paid service price list.
18. The food and veterinary service: 18.1.  10 working days after this provision referred to in paragraph 17 of the receipt of the application, assess it and, if necessary, check the application specified in the actual operation of the site;
18.2. recorded in the list of the beneficiary of the authorisation if: 18.2.1. storage, livestock and animals are registered and labeled according to the requirements of the law on the animal, herd and the recording of holdings and identification of animals;
18.2.2. the permit holder has entered into this provision 9.2 1. referred to in the contract;
18.2.3. the consent holder and the responsible veterinarian practicing in action in the last 12 months is not detected the movement of veterinary medicinal products and medicinal products, maximum residue levels legislation governing the offences that endanger human or animal health;
18.3. specify if the list this provision 9.2 information referred to in paragraph 6;
18.4. at least once a year check the permissions of the recipient;
18.5. the decision to exclude from the list of beneficiaries of the authorisation if: 18.5.1. check reveals the movement of veterinary medicinal products regulatory legislation, which endangers human or animal health;
18.5.2. food of animal origin produced by the beneficiary of the authorisation of veterinary medicinal products, residues in quantities in excess of the maximum residue level;
18.5.3. don't force this provision 9.2 1. referred to in the contract;

18.6. the one working day time following this rule 18.2, 18.3 or 18.5. event referred to update the information in the list;
11.6. the storage of the data about the recipient of the permit not less than five years after the permission requested removal from the list.
19. food and veterinary service list shall contain the following information: 19.1. the registration number of the recipient in the list;
19.2. the date the authorisation of the recipient in the list;
19.3. the name and address of the consignee;
19.4. veterinary care the operator's name, address and legal name of the official veterinarian and veterinary practice certificate number, if this provision 9.2 1. referred to in the contract has been concluded with veterinary care merchant;
19.5. the responsible practitioner name of veterinarian and veterinary practice certificate number, if this provision 9.2 1. referred to in the contract has been concluded with practicing veterinarians;
12.2. This provision 9.2 referred to in paragraph 1 the period of validity of the contract. "
18. To supplement the rules by 19.1 points as follows: "If the permit holder, 19.1 which, according to this provision, section 18.5 is excluded from the list, yet again to get permission for the purchase of veterinary medicinal products, this food and veterinary service of those provisions the application referred to in paragraph 17.
19. The deletion of paragraph 20.
20. Make the following paragraph 21: ' 21. Merchant who received special permission (license) to veterinary pharmacies opening (operation) or to open a drugstore (transaction) with special operating conditions, the distribution of veterinary medicinal products: 21.1. designated as the movement of veterinary medicinal products Executive (veterinarian or pharmacist) and suitably qualified person replace the movement of veterinary medicinal products in the absence of officials responsible;
21.2. ensure that the movement of veterinary medicinal products officer job duties throughout the pharmacy work;
21.3. can perform on the movement of veterinary medicinal products the responsible duties, if he is a veterinarian or pharmacist. "
21. Supplement with 25.1 points as follows: "the 25.1 veterinary drug to the owner or keeper of the animal shall be issued by a person who is a veterinary education. In the case of veterinary medicinal products distributed by the pharmacy, the pharmacist may be issued. The person who issues the veterinary medicinal product, provide advice to the owner or keeper of the animal on the use of veterinary medicinal products. Pharmacy or veterinary pharmacy in visible places in veterinary or pharmaceutical education or qualifications, a copy of the document attesting to the qualifications of the person issuing veterinary medicine. "
22. Delete paragraph 26 and 27.
23. Make the paragraph 32 as follows: "32. Natural person crossing the Latvian border with animals may be imported and exported animals for veterinary medicinal products (other than medicine, which is in Latvia controlled drugs and psychotropic substances list II substances (narcotic drugs) and (iii) the list of substances (hereinafter referred to as psychotropic drugs)) treatment, which may not exceed two months. Where an animal is necessary to ensure the continuous availability of medical indication, individual animal for narcotic drugs may be imported and exported for treatment that is not longer than 14 days, but psychotropic drugs – treatment, not exceeding 30 days. The need for veterinary medicinal products shall be certified by a practicing veterinarian prescription prescriptions or prescription copy is signed by the veterinary practice and the imprint of the stamp of the approved medical practitioner, veterinarian, or other proof of this fact. "
24. Replace paragraph 33, the words "and it subsidiaries ' lieltirgotav ' and lieltirgotav '.
25. replace paragraph 34 the words "lieltirgotav and lieltirgotav branches" with the words "and lieltirgotav".
26. Replace paragraph 35, the word "five" with the word "three".
27. To delete the third sentence of paragraph 40.
28. Make 42 as follows: "42. Veterinary medicinal products which is expired, cancelled, returned or rejected veterinary medicine veterinary medicine manufacturer and importer stores especially provided for this purpose in a separate room or in a delimited space."
29. Delete paragraph 44 in the introductory part, the words "and its subsidiaries".
30. the introductory part of paragraph 46 is deleted, the words "and its affiliate".
31. The deletion of paragraph 47, the words "and lieltirgotav branches".
32. Delete 53, 54 and 55.
33. paragraph 57 of the introductory paragraph be deleted, the word "hazardous".
34. The deletion of Chapter VII.
35. the express section 39.3. the following wording: "veterinary care merchant 39.3., or the recipient of the permit, which shall submit to the responsible official veterinarian medical discharge request."
36. To supplement the rules by 64.1 points by the following: "health inspections at 64.1 food and veterinary service proposal is entitled to prohibit the manufacture of veterinary medicinal products, imports and distribution (including delivery) across the territory of Latvia or its part if the products of animal origin for human health has been found dangerous levels of the medicinal product by the use of the product according to the instructions for use of the product."
37. Make 99. paragraph by the following: "99. State Agency of medicines shall take a decision on the authorisation of veterinary medicinal products imported in parallel distribution in Latvia or the refusal to issue the permit parallel import distribution of veterinary medicinal products in Latvia. If a decision on issuing a permit, State Agency of medicines shall issue the authorisation of veterinary medicinal products imported in parallel distribution in Latvia (annex 4). "
38. Make 100 introductory paragraph as follows: "100. State Agency of medicines shall take a decision on the refusal to issue a permit parallel import distribution of veterinary medicinal products in Latvia, if:".
39. To complement the provisions of the following paragraph to 130.6.: "130.6. period during which the medication withdrawal exceeds the withdrawal period laid down in the legislation on maximum residue levels of the medicinal products in foodstuffs of animal origin."
40. Delete paragraph 158, the words "the Sanitary border inspection".
41.175. point be expressed as follows: "175. State Agency of medicines shall decide on the distribution of veterinary medicinal products registered in the licence: 175.1. This provision 172. in the case referred to in paragraph 1 within 10 working days of the receipt of the application, or, if this is requested in paragraph 163 of the rules of the food and veterinary service, within 10 working days of receipt of the opinion;
175.2.165. these provisions in the case referred to in paragraph 1, the administrative procedure law. "
42. To supplement the provisions of this subparagraph with 181.9.: "181.9. the veterinary medicinal product is prohibited in accordance with the movement of veterinary medicinal products regulatory laws and requirements."
43. The deletion of Chapter XVIII.
44. Deletion of annex 1.
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