RESOLUTION OF THE CABINET OF MINISTERS OF UKRAINE

of February 3, 2010 No. 260

Some questions of the state quality control of medicines

According to article 15 of the Law of Ukraine "About medicines" the Cabinet of Ministers of Ukraine decides:

1. Approve applied:

Procedure of the state quality control of medicines;

Procedure for sampling of medicines for the laboratory analysis during implementation of the state quality control of such means.

2. Recognize invalid:

the resolution of the Cabinet of Ministers of Ukraine of April 26, 2003 No. 610 "About approval of the Procedure for sampling of medicines for the state control of their quality" (The Official Bulletin of Ukraine, 2003, Art. No. 18-19, 828);

item 4 of changes which are made to resolutions of the Cabinet of Ministers of Ukraine, approved by the resolution of the Cabinet of Ministers of Ukraine of December 20, 2008 No. 1122 (The Official Bulletin of Ukraine, 2008, No. 100, the Art. 3313).

Approved by the Resolution of the Cabinet of Ministers of Ukraine of February 3, 2010, No. 260

Procedure of the state quality control of medicines

1. This Procedure determines the mechanism of implementation of the state quality control of medicines for the purpose of non-admission of the address of the counterfeited, low-quality and unregistered medicines.

Action of this Procedure extends to health care institutions, including those which perform activities for wholesale and retail trade by medicines, irrespective of pattern of ownership (further - subjects of housekeeping).

2. The state quality control of medicines is exercised by Gosleksluzhboy, public services on medicines and control of drugs in areas and Kiev by check of observance by subjects of housekeeping of requirements of the legislation concerning quality of medicines and in the cases of carrying out the laboratory analysis of samples of medicines determined by the legislation.

For implementation of the state quality control of medicines officials of noted bodies will see off:

verification of accompanying documents to series of medicines;

selective visual inspection of compliance of medicines to requirements of the specification of quality;

sampling of medicines in the cases provided by Procedure for sampling of medicines for the laboratory analysis during implementation of the state quality control of such means.

The procedure for carrying out scheduled and unscheduled inspections is determined by the Law of Ukraine "About the basic principles of the state supervision (control) in the sphere of economic activity".

3. Sampling for the laboratory analysis is made according to Procedure for sampling of medicines for the laboratory analysis during implementation of the state quality control of such means.

Along with decision making the decision concerning stop of the address of the corresponding series is made on sampling for carrying out the laboratory analysis of medicines in case of identification of discrepancies in accompanying documents to series of medicines or discrepancies of medicine to requirements of the specification of quality by results of visual inspection.

4. Based on the statement which is drawn up by results of check during which conducting violation of requirements of the legislation is revealed within five working days after its completion the instruction, the order or other ordering document on elimination of the violations found during check is constituted.

5. Results of the state quality control of medicines can be appealed in MZ or in court in accordance with the established procedure.

Approved by the Resolution of the Cabinet of Ministers of Ukraine of February 3, 2010, No. 260

Procedure for sampling of medicines for the laboratory analysis during implementation of the state quality control of such means

1. This Procedure determines the mechanism of sampling of medicines for the laboratory analysis during implementation of the state quality control of such means for the purpose of non-admission of the address of the counterfeited, low-quality and unregistered medicines.

2. Sampling of medicines during implementation of the state control of their quality (further - sampling) is made according to the solution of Gosleksluzhby, and also public services on medicines and control of drugs (further - territorial services) Sevastopol (territorial services are farther).

The decision concerning sampling for carrying out the laboratory analysis is made in case:

discrepancies of medicine to requirements of the specification of quality by results of visual inspection;

identifications of discrepancies in accompanying documents to series of medicines;

violations of the established conditions of production of medicine in drugstore according to the recipe of the doctor, storage, transportation and realization of medicine which can negatively affect its quality.

Noted decision can be made also in other cases provided by the law.

3. The subject of housekeeping provides access for officials to Gosleksluzhby, territorial services in the place of implementation of economic activity to medicines for sampling taking into account the set operating mode.

Sampling is made by officials of Gosleksluzhby, territorial services in the presence of the head of the subject of housekeeping or person authorized by it and makes sure the sampling report.

Person authorized on carrying out sampling prior to selection shall show to the subject's representative housekeeping of the decision on sampling and acquaint him with procedure for such selection.

4. The laboratory analysis on compliance of medicines to requirements of the specification of quality (further - the laboratory analysis) is carried out in the cases determined by this Procedure on the medicine methods of quality control approved by MZ during medicine registration or the methods established in the State pharmacopeia of Ukraine.

5. About sampling for the laboratory analysis by officials of Gosleksluzhby, territorial services draw up the statement in triplicate in the form approved by MZ with reasons for the reason of selection.

All copies are signed by the official who made sampling, and the subject's head who is present during selection housekeeping or person authorized by it.

The first copy of the act remains at the official who constituted it, the second - is applied to samples of medicines, third - is told to the head of the subject of housekeeping who is present during selection or person authorized by it.

Half of the selected samples of medicine is packed separately, oplombirovyvatsya and transferred to the subject of housekeeping for storage according to the established conditions as control sample. The official who selected samples and the head of the subject of housekeeping who is present during selection or is authorized by it person put down the signatures on packaging.

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