Amendments To The Cabinet Of Ministers Of 12 August 2003, Regulations No. 445 "production And Veterinary Medicinal Product Control Procedure"

Original Language Title: Grozījumi Ministru kabineta 2003.gada 12.augusta noteikumos Nr.445 "Veterināro zāļu ražošanas un kontroles kārtība"

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Cabinet of Ministers Regulations No. 331 in Riga, 2006 April 25 (Mon. No 24 39) amendments to the Cabinet of Ministers of 12 august 2003, regulations No. 445 "production of veterinary medicinal products and the inspection order Issued in accordance with article 5 of the law of Pharmacy (3) to make the Cabinet on 12 august 2003, regulations No. 445" production of veterinary drugs and control arrangements "(Latvian journal, 2003, 114 no) the following amendments: 1. provisions supplementing with 4.4 subparagraph by the following:" 4.4. veterinary medicinal products imported from a third country. "
2. Replace 7.1.2., 8.1 and 8.2 above, point 15, point 22.1, 23, 24 and 25 and 27.3 in the words "food and veterinary service" (fold) with the words "the State Agency of medicines" (fold).
3. Replace paragraph 13.2, paragraph 21, 22.4., 27., and in paragraph 30, the words "food and veterinary service" (fold) with the words "national pharmaceutical inspection" (fold).
4. To express 17 as follows: "17. quality control of veterinary medicinal products shall be carried out by the National Agency for medicines, as well as laboratory, accredited national agency" Latvian National Accreditation Bureau "and for which the economic Ministry has published a notice in the newspaper" journal. ""
5. Make the following paragraph 22.2.: 22.2. create a complaint "for registration and examination system, as well as inform the State Agency of medicines and the national pharmaceutical inspection for each found medicines or form defects. State Pharmacy Inspectorate shall decide on the withdrawal of the medicinal product concerned, withdrawal or suspension of the distribution; ".
6. Express 26 the following: "26. national pharmaceutical inspection controls the execution of these rules."
7. Make the introductory paragraph 29 by the following: "29. national pharmaceutical inspection shall take a decision on veterinary medicinal products (one of a series of veterinary medicinal products) production suspension, ban on imports of veterinary medicinal products from third countries, the veterinary medicinal products from the market or provide Pharmaceutical activities Licensing Commission in writing proposals for special permission (license) the suspension or cancellation of the following cases:".
8. Delete paragraph 31.
9. Make the paragraph 32 as follows: "32. national pharmaceutical inspection and national agency decisions and actual action may be challenged in the Ministry of health. The Ministry of health decision may appeal to the Court of Justice of the administrative procedure law. "
Prime Minister a. Halloween Minister of Agriculture m. Roze Editorial Note: rules shall enter into force on 29 April 2006.