of January 25, 2022 No. 5
About change of resolutions of the Ministry of Health of the Republic of Belarus
Based on parts seven, the ninth Article 20, of part four of article 21 of the Law of the Republic of Belarus of July 20, 2006 No. 161-Z "About drug circulation", subitem 8.25-3, of the paragraph of the fourth subitem 8.51 of Item 8, of subitems 9.1 and 9.8 of Item 9 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, the Ministry of Health of the Republic of Belarus DECIDES:
1. Make changes to the following resolutions of the Ministry of Health of the Republic of Belarus:
1.1. in the resolution of the Ministry of Health of the Republic of Belarus of October 13, 2008 No. 168 "About setting standards of time and consumption rates of materials when carrying out by the state organizations health care of testing of medicines, pharmaceutical substances":
state the name in the following edition:
"About setting standards of time and the material consumption when carrying out testing of medicines";
state preamble in the following edition:
"Based on the paragraph of the fourth subitem 8.51 of Item 8 and subitem 9.1 of Item 9 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, the Ministry of Health of the Republic of Belarus DECIDES:";
state Items 1 and 1-1 in the following edition:
"1. Establish regulations of time and the material consumption when carrying out testing of medicines by the test laboratories accredited in the National accreditation system of the Republic of Belarus, except for test laboratories of producers of medicines (further - test laboratories), according to appendix.
1-1. Determine that the regulations of time and the material consumption when carrying out testing of medicines by test laboratories established by this resolution extend to the relations connected with rendering services (performance of works) on:
to approbation of techniques of quality control of medicine and quality control of this medicine with use of such techniques;
to quality control of medicines before their receipt in realization, and also the medicines which are in circulation in the territory of the Republic of Belarus;
to quality control of the medicines made in drugstores.";
to be reworded as follows appendix to this resolution it (is applied);
1.2. in Item 1 of the resolution of the Ministry of Health of the Republic of Belarus of April 23, 2018 No. 36 "About provision of powers":
add subitem 1.1 with the paragraph of the following content:
"implementation of measures for ensuring proper accomplishment by holders of registration certificates of tasks and obligations for pharmakonadzor according to requirements of Rules of proper practice of pharmakonadzor of the Eurasian Economic Union;";
state subitem 1.2 in the following edition:
"1.2. pharmaceutical inspectorate of the Ministry of Health:
department of pharmaceutical inspection of the Ministry of Health on:
the organization and (or) conducting inspections (pharmaceutical inspections) of stages (processes) of drug circulation on compliance to requirements proper pharmaceutical the practician in the field of drug circulation;
the organization of implementation of the state pharmaceutical supervision of observance by the checked subjects of requirements of the legislation on drug circulation, including regarding conditions of industrial production, pharmaceutical production, realization, storage, transportation and medical application in the organizations of health care of medicines;
the organization of carrying out certification of authorized persons of producers of medicines of the Republic of Belarus taking into account requirements of the international legal acts constituting the right of the Eurasian Economic Union;
public institution "The state pharmaceutical supervision in the field of drug circulation Gosfarmnadzor (further - GU "Gosfarmnadzor") on:
the organization and conducting inspection on compliance to requirements of Rules of proper distributor practice within the Eurasian Economic Union;
carrying out and technical supply of inspection (pharmaceutical inspection) of industrial production of medicines on compliance to requirements of the Proper production practice, and also on compliance to requirements of Rules of proper production practice of the Eurasian Economic Union;
the organization and conducting inspection (pharmaceutical inspection) of pharmaceutical production of the revealed low-quality medicine regarding compliance to requirements of Proper pharmaceutical practice and the State pharmacopeia of the Republic of Belarus;
implementation of organizational and methodical management of activities of the test laboratories (except test laboratories of producers of medicines) accredited in the National accreditation system of the Republic of Belarus for testing of medicines before receipt in realization and also the medicines which are in circulation in the territory of the Republic of Belarus;
technical supply of forming, maintaining and use:
register of authorized persons of producers of medicines of the Republic of Belarus;
register of pharmaceutical inspectors of the Republic of Belarus;
technical supply of realization in national segment of the Republic of Belarus of general processes on forming, maintaining and use:
register of authorized persons of the Eurasian Economic Union;
register of pharmaceutical inspectors of the Eurasian Economic Union;
the single information database of the medicines which are not conforming to quality requirements and also the counterfeited medicines revealed in the territories of state members of the Eurasian Economic Union;
the single information database on the medicines suspended, withdrawn and prohibited to medical application;
republican kliniko-pharmacological laboratory Center of Examinations and Testing Unitary Enterprise on:
conducting inspection (pharmaceutical inspection) of clinical trials (testing) of medicines regarding compliance to requirements of Rules of proper clinical practice of the Eurasian Economic Union;
conducting inspection (pharmaceutical inspection) regarding compliance of the organization and functioning of system of pharmakonadzor of holders of registration certificates to requirements of Rules of proper practice of pharmakonadzor of the Eurasian Economic Union;";
state subitem 1.3 in the following edition:
"1.3. the republican unitary enterprise "LOTIOS Scientific and Practical Center" on the organization of carrying out certification of authorized persons of producers of medicines of the Republic of Belarus taking into account requirements of the international legal acts constituting the right of the Eurasian Economic Union.";
1.3. in the resolution of the Ministry of Health of the Republic of Belarus of November 18, 2020 No. 103 "About procedure for certification, forming and maintaining registers of authorized persons of producers of medicines, pharmaceutical inspectors":
in the Instruction about requirements imposed to authorized persons of producers of medicines and procedure for their certification approved by this resolution:
in the paragraph the second Item 11 to "appendix" shall be replaced with words the word to "appendix 1";
state Item 19 in the following edition:
"19. The certifying commission in time of no more than 15 working days performs preparation and the direction of the draft of the order of the Ministry of Health on certification of the authorized person, the copy of the minutes of certifying commission in department of pharmaceutical inspection of the Ministry of Health.
In time no later than five working days after the publication of the order of the Ministry of Health to the applicant the notification on results of certification goes.
The certificate on certification of the authorized person of the producer of medicines in form according to appendix 2 is granted by the Ministry of Health according to the legislation on bases of ministerial procedures.";
in signature stamp of appendix to this Instruction the word "Appendix" shall be replaced with words "Appendix 1";
add the Instruction with appendix 2 it (is applied);
in the Instruction about procedure for forming and maintaining the register of authorized persons of producers of medicines of the Republic of Belarus approved by this resolution:
in Item 3:
state part one in the following edition:
"3. The register is created by the Ministry of Health based on public institution "The state pharmaceutical supervision in the field of drug circulation Gosfarmnadzor (further - GU "Gosfarmnadzor")".;
the paragraph one of part two to state in the following edition:
"GU "Gosfarmnadzor" performs:";
in paragraph four of item 4 and part two of Item 8 of the word "RUP "The Center of Examinations and Testing in Health Care" shall be replaced with words "GU "Gosfarmnadzor";
in the Instruction about procedure for forming and maintaining the register of pharmaceutical inspectors of the Republic of Belarus approved by this resolution:
in Item 3:
state part one in the following edition:
"3. The register is created by the Ministry of Health based on public institution "The state pharmaceutical supervision in the field of drug circulation Gosfarmnadzor (further - GU "Gosfarmnadzor")".;
the paragraph one of part two to state in the following edition:
"GU "Gosfarmnadzor" performs:";
in part two of Item 8 of the word "RUP "The Center of Examinations and Testing in Health Care" shall be replaced with words "GU "Gosfarmnadzor".
2. This resolution becomes effective in the following procedure:
paragraphs the fourth - the twenty fifth subitem 1.2 and paragraphs the tenth - twenty third subitem 1.3 of Item 1 of this resolution - since June 1, 2022;
other provisions of this resolution - after its official publication.
|
Minister |
D.L.Pinevich |
|
It is approved Ministry of Foreign Affairs of the Republic of Belarus |
|
Appendix
to the Resolution of the Ministry of Health of the Republic of Belarus of October 13, 2008 No. 168
(in edition of the Resolution of the Ministry of Health of the Republic of Belarus of January 25, 2022 No. 5)
Regulations of time and the material consumption when carrying out testing of medicines by test laboratories
|
№ |
Name of service (work) |
Unit of measure of type of service (work) |
Characteristic of service (work) |
Regulation of time (min.), except for time which is not requiring presence of the specialist when carrying out testing |
The specialists rendering service (performing work) |
Name of consumable materials and reagents |
Unit of measure |
Consumption rate of consumable materials and reagents | |||
|
1 |
2 |
3 |
4 |
5 |
6 |
7 |
8 |
9 | |||
|
Chemical and physical and chemical test methods | |||||||||||
|
1 |
Capture of hinge plate on pharmaceutical scales |
One weighing |
The choice of scales according to loading. Preparation for work. |
12 min. |
Pharmacist-analyst, chief specialist, leading expert, specialist |
Cotton wool |
kg |
0,001 | |||
|
Ethyl alcohol of 96 % |
kg |
0, 000 81 |
|||||||||
|
Ether |
kg |
0,001 |
|||||||||
|
2 |
Capture of hinge plate on the torsion scales |
One weighing |
The choice of scales according to loading. Preparation for work. |
13 min. |
Pharmacist-analyst |
Cotton wool |
kg |
0,001 | |||
|
Ethyl alcohol of 96 % |
kg |
0, 000 81 |
|||||||||
|
Ether |
kg |
0,001 |
|||||||||
|
3 |
Capture of hinge plate on analytical scales |
One weighing |
Warming up of scales. Wiping of cups of scales spirtoefirny mix. Preparation for work. Calibration and check of scales before use. |
14 min. |
Pharmacist-analyst, chief specialist, leading expert, specialist |
Cotton wool |
kg |
0,001 | |||
|
Ethyl alcohol of 96 % |
kg |
0, 000 81 |
|||||||||
|
Ether |
kg |
0,001 |
|||||||||
|
4 |
Dissolution of hinge plate in measuring flask ( taking into account consumable materials and reagents) |
One testing |
The room of hinge plate in measuring flask. Dissolution regarding the solvent. Bringing to tag by the solvent. Hashing |
6 min. |
Pharmacist-analyst, chief specialist, leading expert, specialist |
– |
– |
– | |||
|
5 |
Substance extraction by the organic solvent ( taking into account consumable materials and reagents) |
One testing |
Measuring off of solvents. The room of the examinee of sample and solvents in flask or dividing funnel according to the regulating document on quality. |
23 min. |
Pharmacist-analyst, chief specialist, leading expert, specialist |
– |
– |
– | |||
|
6 |
Otgonka of the organic solvent |
One testing |
Measuring off of the examinee of sample and its room in round-bottomed flask. Heating of water bath of the rotor evaporator. Connection of all parts of the rotor evaporator. Connection of the rotor evaporator to the vacuum pump. Otgonka of the solvent. Dismantle of the device |
16 min. |
Pharmacist-analyst, chief specialist, leading expert, specialist |
– |
– |
– | |||
|
7 |
Drying of substances up to the permanent weight |
One testing |
Inclusion of drying cabinet, installation of temperature, removal on operating mode. Weighing of empty byuks. The room in drying cabinet and drying. Chilling in the exsiccator and weighing. Capture of hinge plate in dried up and weighed бюкс. |
90 min. |
Pharmacist-analyst, chief specialist, leading expert, specialist |
Cotton wool |
kg |
0,001 | |||
|
Ethyl alcohol of 96 % |
kg |
0, 000 81 |
|||||||||
|
Ether |
kg |
0,001 |
|||||||||
|
8 |
Drying of substances |
One testing |
Inclusion of drying cabinet, installation of temperature, removal on operating mode. Weighing of empty byuks. The room in drying cabinet and drying. Chilling in the exsiccator and weighing. |
30 min. |
Pharmacist-analyst, chief specialist, leading expert, specialist |
Cotton wool |
kg |
0,001 | |||
|
Ethyl alcohol of 96 % |
kg |
0, 000 81 |
|||||||||
|
Ether |
kg |
0,001 |
|||||||||
|
9 |
Ashing and weighing of remaining balance |
One testing |
Weighing of empty crucible. The room of empty crucible in the muffle furnace. Turning on of the muffle furnace, installation of temperature, calcinating. |
180 min. |
Pharmacist-analyst, chief specialist, leading expert, specialist |
Cotton wool |
kg |
0,001 | |||
|
Ethyl alcohol of 96 % |
kg |
0, 000 81 |
|||||||||
|
Ether |
kg |
0,001 |
|||||||||
|
10 |
Determination of ashes, insoluble in hydrochloric acid |
One testing |
Ashing. |
278 min. |
Pharmacist-analyst, chief specialist, leading expert, specialist |
The filter deashed (100 pieces / unitary enterprise.) |
unitary enterprise. |
0,01 | |||
|
The hydrochloric acid concentrated |
kg |
0, 011 8 |
|||||||||
|
Cotton wool |
kg |
0,001 |
|||||||||
|
Ethyl alcohol of 96 % |
kg |
0, 000 81 |
|||||||||
|
Ether |
kg |
0,001 |
|||||||||
|
11 |
Determination of sulphatic ashes |
One testing |
Weighing of empty crucible. The room of empty crucible in the muffle furnace. Turning on of the muffle furnace, installation of temperature, calcinating. |
180 min. |
Pharmacist-analyst, chief specialist, leading expert, specialist |
The sulphuric acid concentrated |
kg |
0, 005 49 | |||
|
12 |
Solution measuring off by the burette (pipette), cylinder |
One measuring off |
Measuring off of necessary amount of solution in necessary reservoir |
2 min. |
Pharmacist-analyst, chief specialist, leading expert, specialist |
– |
– |
– | |||
|
13 |
Sedimentation ( taking into account consumable materials and reagents) |
One testing |
Capture of hinge plate on scales. Measuring off of reactants. Receipt of deposit |
30 min. |
Pharmacist-analyst, chief specialist, leading expert, specialist |
– |
– |
– | |||
|
14 |
Washing of deposit ( taking into account consumable materials and reagents) |
One testing |
Transferring of deposit on the filter. Washing of deposit |
62 min. |
Pharmacist-analyst, chief specialist, leading expert, specialist |
Filter paper (100 pieces / unitary enterprise.) |
unitary enterprise. |
0,01 | |||
|
15 |
High-quality determination of one substance without its extraction (chemical method) ( taking into account consumable materials and reagents) |
One testing |
Measuring off of necessary reactants. |
7 min. |
Pharmacist-analyst, chief specialist, leading expert, specialist |
– |
– |
– | |||
|
16 |
High-quality determination of one substance with its extraction (chemical method) ( taking into account consumable materials and reagents) |
One testing |
Substance extraction by the organic solvent. Addition to extract of several solutions of reactants for receipt of the visible effect described in technique (colourings, draft , etc.) |
30 min. |
Pharmacist-analyst, chief specialist, leading expert, specialist |
– |
– |
– | |||
|
17 |
Quality control of the medicine made in drugstore ( taking into account consumable materials and reagents) |
One testing |
High-quality express-analysis. |
41 min. |
Pharmacist-analyst, chief specialist, leading expert, specialist |
– |
– |
– | |||
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