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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. 1232 Riga 2010 December 28 (Mon. No 75 66) 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 12 and paragraph 48. the first paragraph of article 1 do Cabinet of 19 June 2007 the provisions of no. 407 "labelling of the veterinary medicinal product, distribution, and control rules" (Latvian journal, 2007, 2009, 100 no; no 195) the following amendments : replace text 1.1 and the words "in the annexes to the State Agency of medicines" (fold) with the words "food and veterinary service" (fold);
1.2. to replace the text and annexes of the words "health inspection" (fold) with the words "food and veterinary service" (fold);
1.3. Express 3.1. and 3.2. subparagraph by the following: "3.1. merchant who received special permission (license) manufacture of veterinary medicinal products, or special permit (license) for the manufacture of medicinal products, if the scope of the licence – the manufacture of veterinary medicinal products (hereinafter referred to as a manufacturer of veterinary medicinal products);
3.2. merchant who received special permission (license) manufacture of veterinary medicinal products if the scope of the licence – the importing of veterinary medicinal products, or special permit (license) for the manufacture of medicinal products, if the scope of the licence – the importing of veterinary medicinal products (hereinafter importer). The importing of veterinary medicinal products imported into the European Union customs territory from a third country (a country which is not a Member State of the European Union or the European Free Trade Association countries that signed the agreement on the European economic area) (hereinafter referred to as imports); ";
1.4. delete paragraph 3.3., the words "annex a";
1.5. deletion of paragraph 3.4, the words "(open or general type of veterinary pharmacy and veterinary care closed or merchant pharmacy)";
1.6.6.2 and 6.3 in expressing subparagraph by the following: "6.2. it is properly qualified staff and constantly and continuously have at least one qualified person who, in the qualification and professional experience corresponds to the responsible of the qualification and professional experience criteria laid down in legislation on veterinary medicine production and control procedures for veterinary medicinal products, the manufacturer shall issue a certificate of good manufacturing practice for veterinary medicinal products, and the production of officers qualifications and professional experience requirements;
6.3. imported veterinary medicinal product quality assurance implementation requirements laid down in the law on the manufacture of veterinary medicinal products and control the order in which the veterinary medicinal product, the manufacturer shall issue a certificate of good manufacturing practice for veterinary medicinal products, and the production of officers qualifications and professional experience requirements; ";
1.7. to make paragraph 8 by the following: ' 8. importing of veterinary medicinal products imported or to be imported into lieltirgotav in Latvia controlled the illicit manufacture of narcotic drugs and psychotropic substances and precursors included in list II or III substances and medicinal products (hereinafter referred to as the narcotic drugs and psychotropic drugs), if: a specific Hall 8.1 contains special permit (license) for the manufacture of medicinal products or a special permit (license) for the illicit manufacture of narcotic drugs and psychotropic veterinary medicine production, indicating that the import operation with veterinary drugs and psychotropic drugs are allowed whether lieltirgotav has received a special permit (license) for veterinary medicinal products for the operation of the lietirgotav with the narcotic and psychotropic drugs or special permission (license) to open the medicinal lietirgotav (performance), which indicates that the activity is permitted by a veterinary drugs and psychotropic drugs;
8.2. the State Agency of medicines shall be issued to this provision as referred to in point 8.1 of the special permission (license), consistent with the laws of the special permission (license) pharmaceutical and veterinārfarmaceitisk to the operation of the service, suspension, cancellation, renewal and the agenda has included specific medicines database about the medicinal product and the law "on the illicit manufacture of narcotic drugs and psychotropic substances and to the legitimate movement of medicinal products order" order is issued by the State Agency of medicines from permissions. ";
1.8. to supplement the rules with 8.1 and 8.2 points as follows: "8.1 a Person in another Member State has received a special permit (license) for the manufacture of veterinary medicinal products (import) or for distribution to wholesale and wants Latvia to distribute veterinary medicine before starting distribution of veterinary medicinal products, the food and veterinary service provides the following information: 1. special permits 8.1 (license) holder (trade name and address), legal status, special permissions (licenses) of the award date and number the competent authority of a Member State which has granted special permission (license);
8.1 2. Merchant of the branch or representative office, the company registered and operating address, registration number of the commercial register, phone number, e-mail address and other means of communication;
8.1 3. distribution of veterinary medicinal products in the company officers name, qualifications, phone number, e-mail address;
8.1 4. name of the veterinary medicinal product, the manufacturer, the number of the registration certificate;
8.1 5. date planned for start of distribution of veterinary medicinal products in Latvia.
8.2 food and veterinary service after this provision 8.1 point of receipt of the information referred to in: 8.2 1. If necessary, request from this provision 8.1 1. referred to the competent authorities information about special permissions (licenses) of the holder;
8.2. This provision provides 2 8.1 1., 2., and 3.8.1 8.1 information referred to public availability of food and veterinary service website on the internet. If this provision 8.1 referred 1 person interrupted the distribution of veterinary medicinal products in Latvia, the 10 working days notify the food and veterinary service. Upon receipt of the food and veterinary service changes information concerned. ";
1.9. to replace the words "in paragraph 9.1 authorities (veterinary education and science institutions) and to the people" with the words "veterinary education and science institutions, as well as livestock owners or holders";
1.10. Express 9.2 6.3. subparagraph by the following: "9.2 the responsible veterinarian practicing 6.3 change;"
1.11. to supplement the rules with 9.2 9.2 6.4 7. subparagraph by the following: "9.2 6.4. suspension of economic activity, the livestock exclusion from the State agencies" agricultural data centre "registry or other circumstances when the purchase of a veterinary medicinal product authorised for the operation of the recipient no longer necessary;
9.2 7. If you end this provision 9.2 1. referred to in the contract or economic activity or circumstances when the purchase of a veterinary medicinal product authorised for the operation of the recipient does not need a further five working days provided: 9.2 7.1. inventory of veterinary medicinal products, by comparing the received and spent by the veterinary medicinal product actually remaining quantity of medicinal products;
9.2 7.2. submitting information to the food and veterinary service of the shed's remaining stocks of medicines and on the planned actions with them;
7.3. This provision 9.2 9.2 6.4. in the case referred to in subparagraph remaining stocks of medicines return to vendor or destruction in accordance with the requirements of this regulation. ";
1.12. the express point following 9.3: "9.3 veterinarian practicing responsible: 9.3 1. lists and used veterinary drug in the company receiving authorization in accordance with the movement of veterinary medicinal products regulatory legislation requirements;
9.3 2. within five working days, inform the food and veterinary service about: 9.3 this provision 9.2 2.1 1. termination of the contract referred to in subparagraph a;
9.3 2.2. veterinary practice certificate number. ";
1.13. in expressing subparagraph 1 this 9.4: "1. the receiver 5.8 name, the actual site address, phone number, e-mail address;"
1.14. supplement with 9.5 and 9.6 points as follows: "the responsible veterinarian practicing 9.5 this provision a request referred to in paragraph 9.4 statement in duplicate. One copy will be filed in the other copies lieltirgotav stored in the receiver. The request is valid for 14 days. ";
9.6 authorization recipient this rule 9.4 of this request is stored along with them to receive veterinary medicinal products supporting documents received, on the basis of that request. ";
1.15 deleted words in subparagraph 10.4.7. "as well as those issued by the official veterinarian of the veterinary medicinal product request";
1.16. supplement with 10.5. subparagraph by the following: "10.5. rules stores these requests referred to in paragraph 9.4 of the veterinary medicinal product. ';
1.17. Express 13.1. subparagraph by the following: "13.1. This provision of the information referred to in paragraph 10 and request veterinary medicinal products shall be stored for not less than three years and shall, on request, be produced to the food and veterinary service inspectors;";
1.18. Express 14.1. subparagraph by the following: "it requires health 14.1 inspection or food and veterinary service;";
1.19. the deletion of paragraphs 15 and 16;

1.20. supplement 17.1.1. subparagraph after the word "authorities" with the words "or a person";
1.21. to supplement the provisions under section 17.1.1.1 as follows: "housing and livestock 17.1.1.1 registration number, if the application is lodged by a person;"
1.22. Express 17.2. subparagraph by the following: "17.2. bear with the actual site inspection expenses in accordance with the laws and regulations of the food and veterinary service of the national supervisory and control activities of paid service fee.";
1.23. to supplement the provisions under the following subparagraphs 18.2.1.1: "permit holder 18.2.1.1 (except veterinary institutions of education and science) deals with the keeping of livestock product of animal origin the manufacture or other purposes in practice and the number of animals in the herd is not less than 1.1 these regulations referred to in the annex";
1.24. the express section 18.4 as follows: "18.4. at least once a year check the permissions of the recipient compliance with this provision 9.2, 9.3, 9.4, 9.5 points and requirements referred to in subparagraph 18.2.1.1;";
1.25. the supplement section 18.5.2. beyond words "residue" with the words "or substances prohibited from use in food-producing animals of veterinary medicinal products in accordance with the movement of the regulatory requirements and the laws the Commission 22 December 2009 Regulation (EU) No 37/2009 on pharmacologically active substances and their classification according to their maximum permissible content";
1.26. the express section 18.5.3. the following: "the rules are not in force 18.5.3.9.2 of the agreement referred to in paragraph 1 or the number of animals in the herd for more than six months does not meet this provision in annex 1.1;";
1.27. replace paragraph 19.3, the words "and the address" with the words "legal and actual site address";
1.28. the express 19.1 point as follows: "If the permit holder, 19.1 under this provision or section 18.5.1.18.5.2. been excluded from the list, yet again to get permission for the purchase of veterinary medicinal products, this food and veterinary service of those provisions referred to in paragraph 17 of the application not earlier than one year after the date of the finding of the infringement".
1.29. supplement with 22.3 22.4 22.5, and follows the paragraph: "received and issued to 22.3. veterinary medicinal products shall be listed in accordance with the requirements of this regulation;
22.4. to notify you about the use of the veterinary medicinal product-related adverse reactions, in accordance with the legislation on veterinary pharmacovigilance of the medicinal products;
22.5. to notify you of the veterinary medicinal product with quality defects and counterfeit veterinary medicinal products, as well as to the poor quality of the veterinary medicinal product is withdrawn in accordance with the requirements of this regulation. ";
1.30. the introductory part of paragraph 24 be expressed as follows: "24. Veterinary pharmacy or pharmacy:";
1.31. supplement with 15.2. subparagraph by the following: "15.2. ensure that veterinary medicinal product issued by a person who meets the qualifications of the pharmaceutical law 40 the second paragraph of article 1 or in paragraph 2. ';
1.32. delete paragraph 25;
1. delete paragraph 25.1 of the first and the second sentence;
1.34. deleting the introductory part of paragraph 48, the words "General or open type";
1.35. to supplement the provisions of this subparagraph with 30.1.: 30.1. If the veterinary pharmacy "manufactured drugs: 48.5.1. According to the work to be carried out is in the room or cordoned off part of non-sterile dosage forms, sterile dosage forms, as well as for the manufacture of the veterinary medicinal product, the manufacturing process to provide the necessary utility room;
48.5.2. the manufacture of veterinary medicinal products, the rooms are furnished and equipped according to ensure the quality of veterinary medicinal products manufactured;
48.5.3. the manufacture of veterinary medicinal products on the premises according to the work to be carried out is furnished and equipped for jobs in liquid, soft and hard form for the manufacture of medicinal products, veterinary medicinal products and purified water for analysis, as well as the packaging of the veterinary medicinal product. ';
1.36. delete paragraph 49;
1.37. delete paragraphs 50 and 51 and the number of words in the paragraph "and 49";
1.38. the express 56 the following: "56. Veterinary medicinal products which, with respect to the identity or origin is deliberately misleading highlighted considered counterfeit medicinal products. Counterfeiting concern both original and generic medicines. Fake veterinary drugs can be correct or wrong ingredients, without active ingredients or with them in sufficient quantity or with the pakaļdarināt package. Fake veterinary medicinal products which have been detected in the distribution network, stored separately from other products. They are clearly marked with special indication "not for sale". About counterfeit medicinal products fact launch day shall immediately notify the holder of the registration certificate (holder) and the food and veterinary service. After being informed by the food and veterinary service act according to this provision the requirements laid down in chapters XIV. ";
1.39. Express 64 the introductory paragraph by the following: "64. food and veterinary service is entitled to prohibit the manufacture of immunological veterinary medicinal products, imports and distribution (including delivery) across the Latvian territory or in a part thereof, if:";
1.40.64.1 points to express the following: "64.1 food and veterinary service 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. ';
1.41. the express and 68 67 points by the following: "67. food and veterinary service, deciding on the approval of the change in the registration dossier, you can adopt the following decision: 67.1. set another deadline for the remaining inventory of veterinary medicinal products for distribution, the distribution of permits issued, the remaining inventory of the veterinary medicinal product marketing (annex 2);
67.2. prohibit the remaining inventory of the distribution of the veterinary medicinal product if the change is related to urgent with animal and human health-related limitations and safe use of the product (for example, changes in the therapeutic indications, contraindications, dosages in target species due to get new information about the safe use of medicines), and if the changes are implemented in the registration dossier. The decision taken by the food and veterinary service shall notify the holder of the registration certificate (holder) at the date of adoption of the decision.
68. If the veterinary medicinal product is not re-registered pursuant to the regulations on the registration of veterinary medicinal products or food and veterinary service has refused registration, the registration is suspended or annulled, or the end of the registration period of validity of the certificate, the food and veterinary service of the veterinary medicinal product by the marketing authorisation holder (holder) has the right to request to determine the remaining inventory of medicines distribution period, the distribution of the remaining authorisation of veterinary medicinal products in stock (annex 2). ';
1.42. supplement with 68.1 and 68.2 points as follows: 68.1 mAh "(holder), in accordance with the laws and regulations of the food and veterinary service of the national supervisory and control activities of paid service fee covers the expenses related to the evaluation of the application for authorisation to release the remaining inventory of veterinary medicinal products for sale.
68.2 the food and veterinary service on your home page on the internet puts information on licences issued the remaining inventory of veterinary medicinal products for sale, including: 1. the authorisation holder 68.2 (registration certificate of the veterinary medicinal product holder (holder) or parallel importing);
2. the authorization specified 68.2 registration numbers Latvian register of veterinary medicinal product, the name, the strength and the pharmaceutical form;
3. remaining 68.2 veterinary medicine inventory distribution deadline. ";
1.43. the introductory part of paragraph 69 express this: "69. the food and veterinary service of the veterinary medicinal product at the request of the registration certificate holder (holder), a manufacturer, importer, lieltirgotav, veterinary pharmacy, pharmacy, veterinary care, and proprietorship practicing veterinarian shall give notice of the remaining stocks of veterinary medicinal products which have not undergone the registration documentation of approved changes (also applies to parallel and distributed parallel imported medicinal products). The notification shall state the following information: ";
1. to make 82 as follows: "82. In the case of veterinary medicinal products may enter only a practicing veterinarian, food and veterinary service for specific instructions for use of the veterinary medicinal product or the packaging label is entitled from the obligation that certain particulars shall appear and that the language of the country in which the medicinal product is placed on the market. ';
1.45. Express 85 as follows:

"85. If the registration certificate holder (holder) do not comply with the requirements laid down in this chapter and does not comply with the food and veterinary service's requirements for necessary modifications or amendments on the labelling of the veterinary medicinal product or in the instructions, the food and veterinary service has the right to suspend or revoke a certificate of registration. ';
1.46. Express 94. paragraph by the following: ' 94. If the veterinary medicinal product, the registration certificate holder (holder) has withdrawn the relevant veterinary medicinal products registered in Latvia for a certificate of registration and the revocation of the registration certificate is not associated with the risk to animal and human health or the environment of drug safety, efficacy and quality, imported in parallel distribution of veterinary medicinal products not cancelled. ";
1.47. the supplement with 100.1 points as follows: "100.1 the food and veterinary service on your home page on the internet about the parallel imported medicinal products placed with the following information: 1. the markings and 100.1 approved instructions for use parallel imported medicinal products. If the parallel imported medicinal products for veterinary use is different from the registered in Latvia, veterinary medicinal products, indicate the difference;
100.1 2. parallel importers and parallel imported medicinal products for veterinary use. Information dealt with in accordance with the regulations on the registration of veterinary medicinal products. ';
1.48 to replace the word "101.2 in imported" by the word "imported";
1.49. the express section 101.3. by the following: "101.3. two weeks after the food and veterinary service of receipt of the request, provide information about transactions with parallel imported medicinal products;";
1.50. Express 103. the introductory part of paragraph by the following: "103. If the food and veterinary service of the Commission 24 November 2008. Regulation (EC) No 1234/2008 concerning the examination of variations of a marketing authorisation for medicinal products for human use and veterinary medicinal products for conditions is confirmed by the change in the registration dossier in Latvia registered veterinary medicinal product in relation to which made parallel imports, the food and veterinary service: ";
1.51. make 106 in the first sentence the following wording: "the applicant in accordance with the laws and regulations of the food and veterinary service of the national supervisory and control activities of paid service fee covers the expenses related to the evaluation of the application of the parallel distribution of veterinary medicinal products imported authorization.";
1.52. the express section 107.2. by the following: "the application has changed the 107.2. specified information, but the food and veterinary service is not informed about it;"
1.53. make 120. the third sentence by the following: "food and veterinary service is entitled to recognise other Member States the official medicines control laboratory testing results.";
03. make such paragraph 129: "129. If the sequence of the immunological veterinary medicinal product does not match the manufacturer of a veterinary medicinal product issued the serial output certificate or registration of veterinary medicinal products, the food and veterinary service according to the requirements of these regulations, shall decide on the distribution of the immunological veterinary medicinal product authorisation or refusal to issue a permit and the decision taken shall inform the Member States in which the medicinal product is authorised. ";
1.55. express the introductory paragraph 132 as follows: "132. Veterinary medicinal products registration certificate holder (holder) informs the food and veterinary service:";
1.56. the express point 133 as follows: "133. If you have suspicions about the quality of veterinary medicinal products, the rules referred to in paragraph 56 of the counterfeit drugs or have received a message that the quality of the veterinary medicinal product does not meet the relevant registration conditions referred to in the documentation, the importer, lieltirgotav, pharmacy, veterinary pharmacy, veterinary care of a trader or a practicing veterinarian shall notify the food and veterinary service. If the food and veterinary service of the veterinary medicinal product has not received a marketing authorisation holder (holder) notification of quality defects or the withdrawal of the veterinary medicinal product, the importer or lieltirgotav shall submit such notification the food and veterinary service. ";
1.57. express the introductory paragraph 137 by the following: "137. If the food and veterinary service has detected a fault in the quality of veterinary medicinal products, the food and veterinary service and this provision a person referred to in paragraph 134 of the distribution of veterinary medicinal products, suspension and revocation of inform by telephone and in writing (by fax or by electronic means): ";
1. delete paragraph 140;
1.59. express the introductory paragraph 143 as follows: "143. food and veterinary service after 132. these provisions and referred to in paragraph 133 of the notice and the notice (hereinafter referred to as the notice) receive their evaluation, including whether the information provided therein shall not apply to the use of the veterinary medicinal product-related side effects, and if the quality of the veterinary medicinal product defect may pose risk to human or animal health, assess the possible risks to human and animal health , this risk type, volume and current events. The assessment report shall indicate the following information: ";
1.60.151. points to express the following: "151. food and veterinary service on a case-by-case basis and assess the seriousness of the fault, the damage caused by animal and human health and the environment and to distribute a series of veterinary medicinal product with a quality defect.";
1.61. make introductions to the 152 as follows: "152. If the veterinary medicinal product with quality defects (also applies to parallel imported medicinal products and parallel to izplatāmaj veterinary medicinal products) originally found in Latvia, the food and veterinary service: ";
1.62.158. point be expressed as follows: "158. food and veterinary service provides and controls the decision on the suspension of distribution of veterinary medicinal products and the withdrawal of the veterinary medicinal product, as well as the further actions to be taken.";
1.63. Add to paragraph 158.1 rules with the following: "158.1 food and veterinary service on your home page on the internet put the following information on veterinary medicinal products withdrawn: 1 158.1. name of the veterinary medicinal product, strength, shape, serial number, manufacturer and country of manufacture, the firm but also the registered veterinary medicinal product registration number;
2. revocation reason 158.1 and description of the fault of the veterinary medicinal product. ';
1.162.163. expressing and point as follows: "162. veterinary medicinal products not registered merchant, who distributed food and veterinary service issued by unregistered distribution of veterinary medicinal products.
163. the veterinary medicinal product not registered the reasonableness checks the food and veterinary service, doubt and suspicion, asking a veterinarian Association of Latvia's opinion on the merits of the veterinary medicinal product. ';
1.65. the introductory part of paragraph 165 express this: "165. If the food and veterinary service, based on animal and public health, has received permission to distribute the application in a different Member State registered veterinary drug, the food and veterinary service: ";
1.66.174. points to express the following: "174. before submitting the application, the applicant is not a registered veterinary medicine distribution authorisation, for the evaluation of veterinary medicinal products shall bear the costs, in accordance with the laws and regulations of the food and veterinary service of the national supervisory and control activities of paid service fee.";
1.67. the deletion of the words in subparagraph 175.1. "food and veterinary service";
1.37. supplement with 175.1 point as follows: "175.1 food and veterinary service on your home page on the internet puts information on veterinary medicinal products for which issued these regulations not mentioned in paragraph 172 registered the distribution of veterinary medicinal products authorised, including: 175.1 1. name of the veterinary medicinal product, the strength or the strength and the pharmaceutical form;
2. active substances 175.1 international non-proprietary name;
3. veterinary medicines 175.1 registration holder (owner) or the applicant's name, address and its European economic area country, which has granted a certificate of registration or in which the application for the certificate of registration;
175.1 4. veterinary medicinal products manufacturer's name and the country;
175.1 5. veterinary anatomic therapeutic chemical classification code;
6. classification of 175.1;
7. lieltirgotav 175.1 (name, license number, the operation veterinārfarmaceitisk address) who received the distribution of veterinary medicinal products registered licence and distribute medicinal product concerned. ';
1.69. delete paragraph 178;
1.70.180.179. and express the point as follows:

"epizootic disease 179. Large or threat of disease the food and veterinary service may temporarily authorise the distribution and use of unregistered immunological veterinary medicinal products, if not registered in Latvia, are not available or are available in small quantities suitable for veterinary medicinal products. The food and veterinary service is entitled to authorize import and use these drugs if you have received permission from the European Commission to use such products. To get European Commission permission for use of such products, by the food and veterinary service shall inform the European Commission of the detailed required the use of immunological veterinary medicinal products.
180. If the animal is exported to a third country, the food and veterinary service is entitled to authorize the treatment of the animals in question apply to immunological veterinary medicinal products which have not been registered in Latvian register of veterinary medicines, but are permitted under the laws of the third country in question, if this medicine risk-benefit assessment of the conditions of use is allowed. ';
1.71. Express 181. introductory paragraph as follows: "181. food and veterinary service movement of veterinary medicinal products regulations govern the cases prohibits the distribution of veterinary medicinal products if:";
1.72. subparagraph expressing 181.5. by the following: "181.5. manufacture of veterinary medicinal products or import does not match the movement of veterinary medicinal products regulations regulatory requirements or quality control of veterinary medicinal products, the manufacturer or the trader's company in the manufacture of veterinary medicinal products do not correspond to the documents that the manufacturer of the veterinary medicinal product or the importer in food and veterinary service of the pharmaceutical law, or, in the case referred to in article 51.2-State Agency of medicines of the veterinary medicinal product in production licence;"
1.73.182. point be expressed as follows: "182. food and veterinary service has the right to impose a prohibition to deliver or withdraw from a trade only contested series of the veterinary medicinal product. ';
74. Express 185 introductory paragraph as follows: "185. food and veterinary service has the right to stop a particular veterinary medicinal product or importing of veterinary medicinal products referred to in the application for a special permit (license) for the manufacture of veterinary medicinal products, or special permissions (licenses) for the production of medicinal products award, if the importing of veterinary medicinal products control time found that:";
1.75. make 187. the second sentence as follows: "If the food and veterinary service, based on risk to human or animal health, challenging another decision of the competent authority of the Member State, it shall inform the relevant competent authority of their objections or requests additional information.";
1.76.189 points to express the following: "189. distribution of the veterinary medicinal product, or suspension, withdrawal, arguing such action, the registration certificate of the veterinary medicinal product holder (holder) reported to the food and Veterinary Office and the Member States in which disseminate these veterinary medicinal product. ';
1.77. supplement with 200 and 201.202. paragraph by the following: "200.67. These provisions, 68, 99, 166. paragraph 172 and the authorisation of the State Agency of medicines issued by 2010 31 December, they are valid until the expiry date.
201. The importer and lieltirgotav to 2011 January 30, provides drug National Agency for the marketing of a veterinary medicinal product (including parallel and distributed parallel imported medicinal products) in 2010. The State Agency of medicines shall gather veterinary medicines consumption statistics for the year 2010 and submit information to the food and veterinary service.
202. The provision referred to in paragraph 9.1 permits issued before January 1, 2011, in force up to 31 December 2011. ";
1.78. supplement with 1.1 annex by the following: ' Annex 1.1 Cabinet of 19 July 2007 regulations no 407 a minimum number of animals in the herd to get permission for the purchase of veterinary medicinal lieltirgotav no PO box
Farm animal species beef unit (1) (number one in the herd) 1.
Cattle 150 2.
Pigs 150 3.
Horses 150 4.
Sheep, goats, 25 5.
Fur animals 15 6.
Poultry 50 note. 1 beef units is calculated in accordance with the Cabinet of Ministers of 2 February 2010. rule 108 "rules on annual State aid to agriculture and its procedure for" 5. table 2 of the annex. "
2. provisions applicable to January 1, 2011.
The Prime Minister, regional development and local Government Minister v. dombrovsky Minister of Agriculture j. Dūklav in