Amendments To The Cabinet Of Ministers Of 25 March 2004, The Regulations No. 168 "labelling Of The Veterinary Medicinal Product, Distribution, And Control Rules"
Original Language Title: Grozījumi Ministru kabineta 2004.gada 25.marta noteikumos Nr.168 "Veterināro zāļu marķēšanas, izplatīšanas un kontroles noteikumi"
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Cabinet of Ministers Regulations No. 330 in Riga, 2006 April 25 (Mon. No 24 38) amendments to the Cabinet of Ministers of 25 March 2004, the regulations No. 168 "labelling of the veterinary medicinal product, distribution, and control rules" Issued in accordance with article 5 of the law on Pharmacy 3 and 12 to make a Cabinet of 25 March 2004, the regulations No. 168 "labelling of the veterinary medicinal product, distribution, and control rules" (Latvian journal, 2004, 49, no. 144) the following amendments: 1. Express 1.2. Sub-paragraph as follows: "1.2. procedure , a food and veterinary service and the national pharmaceutical inspection controls the distribution of veterinary medicinal products; ".
2. Replace 3.1., 3.2., 4.2., 8.1 and 42.3. in paragraph 43 below, 44, 53, 60, 62, 65, 66, 67 and 68, and 72.5 in 72.1, 73, 74, 75, 76, 78, 77, 79, 80 and 81, the words "food and veterinary service" (fold) with the words "the State Agency of medicines" (fold).
3. Replace the 3.1 and 3.2 in. "your name" with the words "issued by".
4. Express 3.4. subparagraph by the following: "3.4. veterinary care establishments and persons engaged in veterinary practice (for practicing veterinarians and the veterinary care business operators) — animal treatment course for medicine."
5. Replace paragraphs 6 and 10 and 24.3. the bottom point, the words "food and veterinary service" (fold) with the words "national pharmaceutical inspection" (fold).
6. To express the point 8.2.2. by the following: "8.2.2. for practicing veterinarians, veterinary practitioner veterinārfeld care Sherr and merchants."
7. Supplement 20.4. subparagraph after the word "the" with the words "the labelling (information specified on the primary or secondary packaging packaging)".
8. Delete 21.5. section.
9. Supplement with 26.9. subparagraph by the following: "specified other 26.9. distribution of regulatory laws."
10. Make the introductory paragraph 46 by the following: «46. primary packaging of the medicinal product (the container or any other package that is in direct contact with the medicinal product) or to the secondary packaging (packaging into which is placed the primary packaging) clearly legible letters the following information, which has been approved by registration of veterinary medicinal products by the national agency of medicinal products:».
11. Delete 46.10. section.
12. Delete 54.8. section.
13. Make the following introductory paragraph 61:61. "this provision, paragraph 60 permit is issued if the applicant for authorization shall be submitted to the national agency in the application of medicines that is designed according to the Cabinet of Ministers on 27 February 2001, rule no. 88 '' drug import, export and distribution rules and drug lieltirgotav open and operational requirements '' laid down in annex 1 to the sample application for the issue of the parallel distribution of medicinal products imported in the Republic of Latvia, adding the application package including the following information: ".
14. Replace the words "paragraph 66.4 received" with the word "received".
15. Add to 69 after the words "food and veterinary service" with the words "and national pharmaceutical inspection according to the competency".
16.70 and 71 to make the point as follows: "70. Medicine State Agency will create and maintain a manufacturer of veterinary medicinal products and veterinary lieltirgotav. The food and veterinary service will create and maintain a register of veterinary pharmacy.
71. a food and veterinary service and the national pharmaceutical inspection according to the competence and scope of veterinārfarmācij of Pharmacy regulatory legislation in the cases specified shall take all the measures necessary to prohibit the distribution of veterinary medicinal products. "
17. the introductory part of paragraph 72 be supplemented by the words "food and veterinary service" with the words "and national pharmaceutical inspection according to the competency".
18. the title of chapter IX be expressed as follows: "IX. Closing questions".
19. To complement the chapter IX with 81.1 points following: 81.1 "special permit (license) for the production of veterinary medicines and veterinary lieltirgotav to open the (operation), issued by the food and veterinary service, they are valid until the expiry date. These special permissions (licenses) Re-register under these rules, a change in the licensed person or there is a change in the place of the pharmaceutical activities. "
20. Make the informative reference to European Union directives as follows: "Informative reference to European Union directives, the regulations include provisions resulting from: 1) of the European Parliament and of the Council of 3 May 2001, Directive 2001/82/EC on the Community code relating to veterinary medicinal products;
2) of the European Parliament and of the Council of 31 March 2004, Directive 2004/28/EC of the European Parliament and of the Council of 3 May 2001, Directive 2001/82/EC on the Community code relating to veterinary medicinal products. "
Prime Minister a. Halloween Minister of Agriculture m. Roze Editorial Note: rules shall enter into force on 29 April 2006.
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