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Amendments To The Cabinet Of Ministers Of 18 July 2006, Regulations No. 600 "registration Procedures For Veterinary Medicinal Products"

Original Language Title: Grozījumi Ministru kabineta 2006.gada 18.jūlija noteikumos Nr.600 "Veterināro zāļu reģistrēšanas kārtība"

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Cabinet of Ministers Regulations No. 666 in the 2007 October (2. No 55 32) amendments to the Cabinet of Ministers of 18 July 2006, regulations No. 600 "registration procedures for veterinary medicinal products" Issued in accordance with article 5 of the law on Pharmacy 3 and 6 points to make the Cabinet on 18 July 2006, regulations No. 600 "registration procedures for veterinary medicinal products" (Latvian journal, 2006, 127 no) the following amendments: 1. A supplement to chapter I, 8.1, 8.2 and 8.3 of the following paragraph: "8.1 registration of veterinary medicinal products Medicine State agency determines the membership of non-prescription veterinary medicines group. 8.2 veterinary medicinal products intended for food-producing animals, classified as non-prescription medicinal products for veterinary use, if its not injectable 8.21.: and use topically or orally (per os), do not need special knowledge or skills; 8.22. even not used according to the instructions on the use of veterinary medicinal products, they do not cause direct or indirect risk to treat the animal (animals), the person who gives the animal medicines, or the environment; 8.23. they do not contain pretparazitār and antimicrobial substances and, even not used according to the instructions for use of the veterinary medicinal product does not pose a risk to human or animal health; 8.24. Description: 8.24.1 is not a warning about potential heavy. side effects (adverse reactions) that depend on their correct use; 8.24.2. the contraindications to other veterinary medicinal products to be used without a prescription; 8.24.3. specific restrictions on the use of animal products in the period after administration; 8.25. they do not need special storage conditions; 8.26. previously reported frequent and severe adverse reactions (reactions), caused by the active substance content of the veterinary medicinal product or any other medications. 8.3 in the case of veterinary medicinal products intended for use in food-producing animals, and both the House (rooms), animals and they do not conform to the provisions mentioned in paragraph 82 of the conditions they recorded as of prescription of veterinary medicinal products. " 2. Supplement with 13.19. subparagraph by the following: "13.19. the document proving the payment of the service in accordance with the State Agency of medicines of the public paid list price." 3. To supplement the provisions of the following paragraph 45.6: "45.6. the registration dossier shall be accompanied by a document proving the payment of the service in accordance with the State Agency of medicines of the public paid list price." 4. the introductory part of paragraph 94 of supplementing the second sentence after the words "registration" with the words "as well as the document proving the payment of the service in accordance with the State Agency of medicines of the public paid services price list". 5. Supplement with 99.1 points as follows: "99.1 the holder of the registration certificate of the rules referred to in paragraph 99 of the application shall be accompanied by a document proving the payment of the service in accordance with the State Agency of medicines of the public paid list price." 6. Add to the informative reference to directives of the European Union with paragraph 3 by the following: "3) 2006 of the Commission's directive of 11 December 2006/130/EC of the European Parliament and of the Council Directive 2001/82/EC, as regards the criteria for certain veterinary medicinal products for food-producing animals the veterinarian's prescription for exemption from the requirements." 7. Annex 1 Worded as follows: "1. the annex to Cabinet of Ministers of 18 July 2006, regulations no 600 Prime Minister a. Halloween Minister of Agriculture m. rose