of May 11, 2015 No. 68
About some questions of monitoring procedure of quality of medicines
Based on part four of article 10 of the Law of the Republic of Belarus of July 20, 2006 "About medicines" and paragraph two of subitem 8.17 of Item 8 of the Regulations on the Ministry of Health of the Republic of Belarus approved by the resolution of Council of Ministers of the Republic of Belarus of October 28, 2011 No. 1446 "About some questions of the Ministry of Health and measures for implementation of the Presidential decree of the Republic of Belarus of August 11, 2011 No. 360" the Ministry of Health of the Republic of Belarus DECIDES:
1. Bring in the resolution of the Ministry of Health of the Republic of Belarus of March 1, 2010 No. 20 "About approval of the Instruction about procedure for test of quality of the medicines registered in the Republic of Belarus before receipt in realization, and also the medicines which are in circulation in the territory of the Republic of Belarus, modification and amendments in the resolution of the Ministry of Health of the Republic of Belarus of January 15, 2007 No. 6 and recognition voided resolutions of the Ministry of Health of the Republic of Belarus of June 24, 2002 No. 37 and Item 14 of the resolution of the Ministry of Health of the Republic of Belarus of December 22, 2006 No. 117" (The national register of legal acts of the Republic of Belarus, 2010, No. 84, 8/22149; National legal Internet portal of the Republic of Belarus, 17.11. 2012, 8/26548) following changes and amendments:
1.1. in the name shall be replaced with words the word "checks" "and monitoring procedure conditions";
1.2. state Item 1 in the following edition:
"1. Establish the list of the test laboratories accredited in accreditation system of the Republic of Belarus for testing of the medicines and pharmaceutical substances registered in the Republic of Belarus before receipt in realization and also medicines and pharmaceutical substances which are in circulation in the territory of the Republic of Belarus, except for the medicines made in drugstores according to appendix.";
1.3. add the resolution with Item 1-1 of the following content:
"1-1. Approve the enclosed Instruction about procedure and conditions of monitoring procedure of quality of the medicines registered in the Republic of Belarus before receipt in realization, and also the medicines which are in circulation in the territory of the Republic of Belarus.";
1.4. To be reworded as follows the instruction about procedure for test of quality of the medicines registered in the Republic of Belarus before receipt in the realization, and also the medicines which are in circulation in the territory of the Republic of Belarus approved by this resolution it (is applied);
1.5. add the resolution with appendix of the following content:
"Appendix
to the Resolution of the Ministry of Health of the Republic of Belarus 01.03.2010 No. 20
The list of the test laboratories accredited in accreditation system of the Republic of Belarus for testing of the medicines and pharmaceutical substances registered in the Republic of Belarus before receipt in realization and also medicines and pharmaceutical substances which are in circulation in the territory of the Republic of Belarus, except for the medicines made in drugstores
|
№ |
Name of test laboratory |
Quality control of medicines and pharmaceutical substances | ||||
|
before receipt in realization |
being in circulation in the territory of the Republic of Belarus |
in case of appeal of results of the carried-out medicine quality control | ||||
|
on all indicators of quality and the Sections "Packaging", "Marking" of pharmacopoeian Article |
on separate indicators of quality and the Sections "Packaging", "Marking" of pharmacopoeian Article or on indicator "Description" and to the Sections "Packaging", "Marking" of pharmacopoeian Article |
on indicators of quality and the Sections "Packaging", "Marking" of the regulating document of the producer | ||||
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