Amendments To The Cabinet Of Ministers Of 17 January 2006 Rules No 61 "regulations On The State Agency Of Medicines Of The Public Paid Services Price List"

Original Language Title: Grozījumi Ministru kabineta 2006.gada 17.janvāra noteikumos Nr.61 "Noteikumi par Zāļu valsts aģentūras publisko maksas pakalpojumu cenrādi"

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Cabinet of Ministers Regulations No. 1186 Riga 2010 December 28 (Mon. No 75 61) amendments to the Cabinet of Ministers of 17 January 2006 rules No 61 "regulations on the State Agency of medicines of the public paid services price list" Issued in accordance with the law on budget and financial management of the ninth paragraph of article 5 to make the Cabinet on 17 January 2006, rules No 61 "regulations on the State Agency of medicines of the public paid services price list" (Latvian journal, 2006, nr. 20; 2007; 2008, 80 no, 146. no; 2009 200. no; 2010, no. 123) the following amendments: 1. Express 3 and paragraph 4 by the following: "3. the provisions of This annex, 91.89, 93, 95, 96, 97, 98, 99.., 100, 103, 106.1 106.2, 106.3, subparagraph and paragraph 112 are valid until 31 December 2011.
4. the State Agency of medicines on the basis of the registration or the registration of the holder of the application by the applicant, is entitled to take a decision on the applicant's release from the drug post-marketing surveillance annual fees if the drug turnover in the previous calendar year did not exceed 1500 dollars, and they need treatment process. "
2. Deleting the introductory part of paragraph 13 of the annex, the words "and veterinary medicine".
3. Delete paragraph 18 of the annex to the introduction, and paragraph 18.1., the words "or veterinārfarmaceitisk".
4. the annex shall be deleted in paragraph 18.2., the words "or veterinary medicinal products".
5. the annex shall be deleted and in paragraph 18.3 18.4. the words "or veterinārfarmaceitisk".
6. Put the attachment 18.6.) (the second and third column the following: "because of the pharmacy branch or chapter of the lieltirgotav of the closure of the company's pharmaceutical operations 1 the documentation of inspection" to express the attachment 7 11.6. the second and third paragraph box as follows: "due to the special permit (license) for pharmaceutical activity suspension 1 operating company pharmaceutical documentation expertise" 8. Express 12.8 in annex.) (the second and third column the following : "because of the pharmacy branch or lieltirgotav the suspension of Chapter 1 of the pharmaceutical company's documentation of the inspection activities" 9. Express attachment 11.7.) (the second and third column the following: "because of changes in the special permission (license) the pharmaceutical activities in term of validity and the annex, if it is not necessary the pharmaceutical activities evaluation of conformity of the company's pharmaceutical operations 1 the company documentation expertise to express" 10.18.10. subparagraph of the annex to the second and third column the following : "changes to the documents and information, you do not need special permissions (licenses) the pharmaceutical activities of pharmaceutical activities 1 re-registering company documentation expertise" 11. Express attachment 18.11.) (the second and third column the following: "special permit (license) for pharmaceutical operation restore, if you do not want the pharmaceutical company's conformity assessment activities 1 inspection" 12.18.12. Annex Express) (the second and third columns are as follows: "special permit (license) for pharmaceutical operation restore or the special permission (license) the pharmaceutical activities specified in the special conditions of operation or specific drug production or import, if you do not want the pharmaceutical enterprises of the conformity assessment activities of the pharmaceutical company 1 documentation inspection "13.18.13. subparagraph of the annex be deleted, the words" or veterinārfarmaceitisk ".
14. Amend Annex 50, 51, 52, 53, 53.1, 54, 55, 53.2 and 56 points.
15. the annex shall be deleted and paragraph 57 57.1, the words "or veterinary medicinal products".
16. Delete paragraph 58 of annex.
17. the annex shall be deleted and paragraph 59.1 59. the words "or veterinary medicinal products".
18. Amend Annex 63, 64, 65, 77, 79, 84, 88, 90, 92 and 94. above.
19. Delete the annex 95, 96 and 98 in paragraph the words "or veterinary medicinal products".
20. To supplement annex 110.109, 111, 112 and 113 above. This wording: "109. Medical Device clinical trial authorisation for the dossier submitted 1000.00 0.00 1 inspection of the documentation Submitted 1000.00 110. inspection, amendment of the authorisation of clinical trials of medical devices in 1 inspection 600.00 0.00 600.00 111. Medical Device clinical trial authorisation renewal following the suspension of the inspection 1 600.00 0.00 600.00 112. Authorisation of medical device clinical trial authorisation to 20.00 0.00 20.00 113. notification of medical devices and the information submitted in the registration procedure of the maintenance and storage of the Latvian medical equipment database (LATMED) one medical device name 30.00 0.00 30.00 "Prime Minister, regional development and local Government Minister v. dombrovsky Health Minister j. Bārzdiņš

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