of October 10, 2016 No. 1130
About modification and amendments in appendix No. 2 to the Order of the Government No. 348 of May 26, 2014
Based on article 11-1 of the Law No. 1456-XII of May 25, 1993 on pharmaceutical activities (repeated publication: The official monitor of the Republic of Moldova, 2005, Art. No. 59-61, 200), with subsequent changes and amendments, article 7 of the Law on drugs No. 1409-XIII for December 17, 1997 (The official monitor of the Republic of Moldova, 1998, Art. No. 52-53, 368), with subsequent changes and amendments, and article 31 of the Law No. 92 of April 26, 2012 on medical products (The official monitor of the Republic of Moldova, 2012, Art. No. 149-154, 480) DECIDES: the Government
In appendix No. 2 to the Order of the Government No. 348 of May 26, 2014. "About rates for the services provided by the Agency on drugs and medical products" (The official monitor of the Republic of Moldova, 2014, Art. No. 134-141, 387) to make the following changes and additions:
1) Section "Rates for Authorization of Medical Supplies, Other Pharmaceutical and Parapharmaceutical Products, Post-registration Changes and Clinical Trials":
Chapter I:
in the name to exclude the word "Specialized";
add with line item of 1-1 following content:
|
"1-1. |
The medicine provided with the complete file the "independent" ("independent") statement - in the simplified procedure of registration (in case of the medicines registered by EMA, FDA or, at least, in one of the countries of European economic space or in Switzerland, the USA, Canada, Japan, Australia) |
1 statement
|
20 237"; |
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