Cabinet of Ministers Regulations No. 1148 in Riga 2010 on December 21 (Mon. No 74 64) amendments to the Cabinet of Ministers dated 10 April 2007, regulations no 246 "veterinary medicinal products, pharmacovigilance procedure" Issued in accordance with article 5 of the law of Pharmacy 6. point 1. make Cabinet 10 April 2007 regulations no 246 "veterinary medicinal products, pharmacovigilance procedures" (Latvian journal, 2007, 2008, 61 No; 53 no) the following amendments: 1. replace the words "in the text of the provisions of the National Medicines Agency" (fold) with the words "food and veterinary service" (fold);
1.2. to replace paragraph 12, the words and figures "of the European Commission of 3 June 2003, Regulation (EC) no 1084/2003 concerning the examination of variations to the terms of a marketing authorisation, the competent authority of the Member States has issued for medicinal products for human use and veterinary medicinal products" with the words and figures "European 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;
1.3. make paragraph 13 the first sentence by the following: "registration certificate of the veterinary medicinal product holder (owner) prohibits the provision to the media for dissemination of information on the use of veterinary medicinal products authorised security if it has not been informed by the food and veterinary service.";
1.4. the express section 14.5 by the following: "14.5. is entitled to take a decision on the registration of veterinary medicinal products, the suspension of the licence for a period of up to half a year, failure to comply with the provisions of paragraph 13 of such requirements;";
1.5. make points 15 and 16 by the following: "15. If after evaluation of the monitoring system data of the food and veterinary service shall decide on the registration certificate of the veterinary medicinal product in the suspension, cancellation or changes in the documentation for the registration of indications, doses (Posology), animal species or breeds, or information on contraindications or supplement the security measures carried out by the use of the veterinary medicinal product to the animals, it shall immediately inform the European Medicines Agency, the competent institution of the other Member States and the veterinary medicinal product by the holder of the registration certificate (the owner).
16. If it is necessary to carry out the urgent public and animal health measures, food and veterinary service is entitled to suspend the certificate of registration of veterinary medicinal products. No later than the following working day of the relevant veterinary medicinal product, the suspension of the registration certificate and the measures to be taken and inform the European Medicines Agency, the European Commission and the competent authorities of the other Member States. ';
1.6. to make 18 the following: "6. The food and veterinary service under the competency rules control this."
2. This provision 1.1., 1.3, 1.4, 1.5 and 1.6. subparagraph shall enter into force on January 1, 2011.
The Prime Minister, regional development and local Government Minister v. dombrovsky, Agriculture Minister Minister of justice a. Štokenberg in