RESOLUTION OF THE MINISTRY OF HEALTH OF THE REPUBLIC OF BELARUS

of October 25, 2012 No. 163

About modification and amendments in some resolutions of the Ministry of Health of the Republic of Belarus

Based on part three of Article 5-2 and part one of article 20 of the Law of the Republic of Belarus of July 20, 2006 "About medicines", subitems 8.17 and 8. 23, the paragraph of the fourth subitem 8.51 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" and in pursuance of Item 2 of the resolution of Council of Ministers of the Republic of Belarus of October 18, 2012 No. 936 "About modification and amendments in resolutions of Council of Ministers of the Republic of Belarus of September 2, 2008 No. 1269 and of October 28, 2011 No. 1446" DECIDES: the Ministry of Health of the Republic of Belarus

1. Make changes and additions to the following resolutions of the Ministry of Health of the Republic of Belarus:

1.1. in Item 43 appendices to the resolution of the Ministry of Health of the Republic of Belarus of January 15, 2007 No. 6 "About approval of Proper practice of wholesale" (The national register of legal acts of the Republic of Belarus, 2007, No. 30, 8/15812; 2010, No. 84, 8/22149):

1.1.1. word part one in paragraph three "series and number of special holographic brand which processes the documents confirming quality of medicine, issued" shall be replaced with words "number and date of the test report of the medicine issued";

1.1.2. in word part three "series and number of special holographic brand which processes the documents issued" shall be replaced with words "number and date of the test report of the medicine issued";

1.2. in the resolution of the Ministry of Health of the Republic of Belarus of October 13, 2008 No. 168 "About approval of regulations of time for services in approbation of methods of the analysis of medicines, pharmaceutical substances, on control of quality of medicines in case of purpose of their clinical testing and on quality check 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, the health cares rendered by the state organizations" (The national register of legal acts of the Republic of Belarus, 2008, No. 262, 8/19674; 2010, No. 162, 8/22519):

1.2.1. in the name "approval" to replace the word with the word "establishment";

1.2.2. in Item 1 to replace the word "approve" with the word "establish";

1.2.3. in appendix to this resolution:

in the column 2 of item 4 "to flask *" to replace the word with the word to "flask";

in the column 2 of Item 5 "the solvent *" to replace the word with the word "solvent";

in the column 2 of Item 12 to replace the word "Sedimentation *" with the word "Sedimentation";

in the column 2 of Item 13 to replace the word "draft *" with the word "draft";

in the column 2 of Items 14 and 15 of the word" (chemical method) *" shall be replaced with words "(chemical method)";

in the column 2 of Item 16 "drugstores *" to replace the word with the word "drugstores";

in the column 2 of Item 29 "the analysis *" to replace the word with the word "analysis";

in the column 2 of Item 30 "raw materials *" to replace the word with the word of "raw materials";

in the column 2 of Item 31 "others *" to replace the word with the word of "others";

in the column 2 of Item 34 "capsules *" to replace the word with the word of "capsules";

in the column 2 of Item 40" (water) *" to replace the word with the word "(water)";

in the column 2 of Item 42 to replace the word "electrometric *" with the word "electrometric";

in the column 2 of Item 44 "alkalinities *" to replace the word with the word "alkalinities";

in the column 2 of Item 45 to replace the word "direct *" with the word "direct";

in the column 2 of Item 46 to replace the word "the return *" with the word "return";

in the column 2 of Item 47 to replace the word "direct *" with the word "direct";

in the column 2 of Item 48 to replace the word "the return *" with the word "return";

in the column 2 of Items 49-51 to replace the word "titration *" with the word "titration";

in the column 2 of Item 52 to replace the word "Saponification *" with the word "Saponification";

in the column 2 of Item 53 to replace the word "Oxidation *" with the word "Oxidation";

in the column 2 of Item 54 to replace the word "Recovery *" with the word "Recovery";

in the column 2 of Item 55 "numbers *" to replace the word with the word "numbers";

in the column 2 of Item 56 "saponifications *" to replace the word with the word "saponifications";

in the column 2 of Item 57 "numbers *" to replace the word with the word "numbers";

in the column 2 of Items 58 and 59 to replace the word "determination *" with the word "determination";

in the column 2 of Item 61 to replace the word "Acetylation *" with the word "Acetylation";

in the column 2 of Item 62 "oils *" to replace the word with the word "oils";

in the column 2 of Item 63 to replace the word "titration *" with the word "titration";

in the column 2 of Item 71 "tablets *" to replace the word with the word "tablets";

in the column 2 of Item 74 of the word" (authenticity determination) *" shall be replaced with words "(authenticity determination)";

in the column 2 of Item 75 of the word" (quantitative determination, chromaticity determination) *" shall be replaced with words "(quantitative determination, chromaticity determination)";

in the column 2 of Item 76 of the word" (creation of calibrating curve) *" shall be replaced with words "(creation of calibrating curve)";

in the column 2 of Item 77 "Kyeldalya *" to replace the word with the word to Kyeldal;

in the column 2 of Item 80 of the word" (authenticity, izmelchennost, content of impurity, infectiousness degree by granary wreckers) *" shall be replaced with words "(authenticity, izmelchennost, content of impurity, infectiousness degree by granary wreckers)";

in the column 2 of Item 88 "the solvent *" to replace the word with the word "solvent";

in the column 2 of Item 91 "by method *" to replace the word with the word by "method";

in the column 2 of Items 92 and 93 "chromatography *" to replace the word with the word "chromatography";

in the column 2 of Item 94 of the word" (quantitative determination, determination of impurity) *" shall be replaced with words "(quantitative determination, determination of impurity)";

in the column 2 of Item 95 of the word" (authenticity determination) *" shall be replaced with words "(authenticity determination)";

in the column 2 of Item 96 of the word" (determination of residual organic solvents) *" shall be replaced with words "(determination of residual organic solvents)";

in the column 2 of Item 97 of the word" (quantitative determination, determination of impurity) *" shall be replaced with words "(quantitative determination, determination of impurity)";

in the column 2 of Item 98 of the word" (authenticity determination) *" shall be replaced with words "(authenticity determination)";

in the column 2 of Items 100 and 101 "substances *" to replace the word with the word of "substances";

in the column 2 of Item 102 to replace the word "arsenic *" to the words "arsenic";

in the column 2 of Item 103 "numbers *" to replace the word with the word "numbers";

in the column 2 of Item 105 of the word" (1 bottle to 100 ml) *" shall be replaced with words "(1 bottle to 100 ml)";

in the column 2 of Item 107 "Fischer *" to replace the word with the word of Fischer;

in the column 2 of Item 109 "numbers *" to replace the word with the word "numbers";

in the column 2 of Item 110 "ursin *" to replace the word with the word of "ursin";

in the column 2 of Item 111 "oxygen *" to replace the word with the word "oxygen";

in Item 112:

to exclude from column 4 of the word "Gluing of Special Holographic Brand.";

state column 7 in the following edition:

"-";

in the column 2 of Item 116 "determinations *" to replace the word with the word "determinations";

in the column 2 of Item 118 "substances *" to replace the word with the word of "substances";

in the column 2 of Item 120 of the word" (by means of crystal) *" shall be replaced with words "(by means of crystal)";

in the column 2 of Item 121 of the word" (by means of bromic tablet) *" shall be replaced with words "(by means of bromic tablet)";

in the column 2 of Item 1211 of the word" (with use ditches) *" shall be replaced with words "(with use ditches)";

in the column 2 of Item 1212 "IK-spectrometry *" to replace the word with the word of Ikspektrometriya;

in the column 2 of Item 123 to replace the word "spectrometry *" with the word "spectrometry";

in the column 2 of Item 124 "radionuclides *" to replace the word with the word of "radionuclides";

in the column 2 of Items 127 and 128 "means *" to replace the word with the word "means";

in the column 2 of Item 129 "appointments *" to replace the word with the word "appointments";

in the column 2 of Item 130 to replace the word "agar *" with the word "agar";

in the column 2 of Item 132 to replace the word "Pyrogenicity *" with the word "Pyrogenicity";

in the column 2 of Item 133 "mice *" to replace the word with the word "mice";

in the column 2 of Item 134 "pigs *" to replace the word with the word "pigs";

in the column 2 of Item 135 "appointments *" to replace the word with the word "appointments";

in the column 2 of Item 136 "immunoelectrophoresis *" to replace the word with the word of "immunoelectrophoresis";

in the column 2 of Item 137 "means *" to replace the word with the word "means";

in the column 2 of Item 138 "appointments *" to replace the word with the word "appointments";

in the column 2 of Item 139 of the word" (manual method) *" shall be replaced with words "(manual method)";

in the column 2 of Item 140 "means *" to replace the word with the word "means";

add appendix with Items 141-146 of the following content:

 

"141	Capillary electrophoresis (authenticity determination)	research	Preparation of the examinee of solution (crushing, capture of hinge plate, measuring off of amount, dissolution during the stirring, action of ultrasound, heating, etc. depending on the nature of the examinee of object, filtering). Comparison solution preparation (crushing, capture of hinge plate, measuring off of amount, dissolution during the stirring, action of ultrasound, heating, etc. depending on the nature of standard sample, filtering). Preparation of buffer solution (weighing, dissolution, finishing amount, finishing рН, filtering). Preparation of the device for work (turning on of the device, warming up of lamps, installation of method, loading of solutions, choice and installation of capillary, thermostating of avtosampler and capillary). Conditioning of capillary. Carrying out electrophoretic separation of the examinee of solution and solution of comparison. Washing of capillary. Assessment of results. Maintenance of the device	343 min.	Pharmacist-analyst, chief specialist, leading expert, specialist	Sodium hydroxide	kg	0,000024
142	Capillary electrophoresis (quantitative determination, determination of impurity)	research	Preparation of the examinee of solution (crushing, capture of hinge plate, measuring off of amount, dissolution during the stirring, action of ultrasound, heating, etc. depending on the nature of the examinee of object, filtering). Preparation of solutions of comparison for graduation and for check of suitability of system (crushing, capture of hinge plate, measuring off of amount, dissolution during the stirring, action of ultrasound, heating, etc. depending on the nature of standard sample, filtering). Preparation of buffer solution (weighing, dissolution, finishing amount, finishing рН, filtering). Preparation of the device for work (turning on of the device, warming up of lamps, installation of method, loading of solutions, choice and installation capillary, thermostating of avtosampler and capillary). Conditioning of capillary. Carrying out electrophoretic separation: the examinee of solution, comparison solutions for graduation, comparison solution for check of suitability of system. Washing of capillary. Carrying out calculations. Maintenance of the device	577 min.	Pharmacist-analyst, chief specialist, leading expert, specialist	Sodium hydroxide	kg	0,000024

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