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The document ceased to be valid since  February 13, 2016 according to Item 1 of the Order of the Government of the Republic of Kazakhstan of January 27, 2016 No. 31

ORDER OF THE GOVERNMENT OF THE REPUBLIC OF KAZAKHSTAN

of January 11, 2012 No. 26

About approval of Rules of destruction of the medicines, products of medical appointment and medical equipment unsuitable to realization and medical application

According to article 79 of the Code of the Republic of Kazakhstan of September 18, 2009 "About health of the people and health care system" the Government of the Republic of Kazakhstan DECIDES:

1. Approve the enclosed Rules of destruction of the medicines, products of medical appointment and medical equipment unsuitable to realization and medical application.

2. This resolution becomes effective after ten calendar days after the first official publication.

 

Prime Minister of the Republic of Kazakhstan

K. Masimov

Approved by the order of the Government of the Republic of Kazakhstan of January 11, 2012 No. 26

Rules of destruction of the medicines, products of medical appointment and medical equipment unsuitable to realization and medical application

1. General provisions

1. These rules of destruction of the medicines, products of medical appointment and medical equipment unsuitable to realization and medical application (further - Rules) are developed according to article 79 of the Code of the Republic of Kazakhstan of September 18, 2009 "About health of the people and health care system" and determine procedure for destruction of medicines, products of medical appointment and medical equipment.

2. In these rules the following concepts are used:

1) medicines, unsuitable to realization and medical application, products of medical appointment and medical equipment - counterfeited, unregistered, expired and others, the legislations of the Republic of Kazakhstan which are not conforming to requirements medicines, products of medical appointment and the medical equipment constituting danger of life and to health of the person;

2) counterfeited medicine - the medicine which is not corresponding on structure, properties and other characteristics to the original or reproduced medicine (generic) of the producer, illegally and purposely supplied with the counterfeit label;

3) the unregistered medicines, products of medical appointment and medical equipment - the medicines which did not undergo in accordance with the established procedure state registration (re-registration) in the Republic of Kazakhstan, products of medical appointment and medical equipment;

4) expiration date of medicine, product of medical appointment - date after which expiration, medicine, product of medical appointment are not subject to medical application;

5) destruction of the medicines, products of medical appointment and medical equipment unsuitable to realization and medical application - the procedure of impact (thermal, chemical, mechanical or other) on the medicine, product of medical appointment and medical equipment excluding possibility of their further use and access to them for the person and animals.

2. Procedure for destruction of medicines, products of medical appointment and medical equipment

3. Counterfeited, unregistered, expired and others, the legislations of the Republic of Kazakhstan which are not conforming to requirements medicines, products of medical appointment and medical equipment are considered unsuitable to realization and medical application, and are liable to destruction by subjects at whose disposal are.

4. The place of destruction unsuitable to realization and medical application of medicines, products of medical appointment and medical equipment is determined by the subject at which disposal they are, by written coordination with territorial subdivision of authorized body in the field of sanitarnoepidemiologichesky wellbeing of the population.

5. Destruction unsuitable to realization and medical application of medicines, products of medical appointment and medical equipment is performed with observance of mandatory requirements of the legislation of the Republic of Kazakhstan in the field of environmental protection, sanitary and epidemiologic wellbeing of the population.

6. Medicines, products of medical appointment and medical equipment are destroyed below by the listed methods:

1) medical equipment is destroyed by dismantle, dismantling, mechanical damage, including punching of holes, gaps, drawing damages by different ways provided that such damages exclude the subsequent recovery of medical equipment and possibility of their use in original form if other is not established in the operational document of medical equipment developed by organizatsiyeyproizvoditel;

2) products of medical appointment are destroyed by burning if other is not established in the instruction on medical application of product of medical appointment developed by the manufacturing organization;

3) liquid dosage forms (solutions for injections in ampoules, in packets and in bottles, mixtures, drops, liquids in aerosol cans) are destroyed by crush with the subsequent cultivation of content water in the ratio 1:100 and discharge of the formed solution in the industrial sewerage (in aerosol cans openings become previously), remaining balance of ampoules, aerosol cans, packets and bottles are exported and destroyed according to requirements of the standard for waste recycling;

4) the firm dosage forms (powders, tablets, capsules) containing water-soluble substances of medicines are subject after crushing to powdery condition to cultivation by water in the ratio 1:100 and discharge of the formed suspension (or solution) in the industrial sewerage;

5) the firm dosage forms (powders, tablets, capsules) containing substances of medicines insoluble in water, soft dosage forms (ointment, suppositories), transdermalny forms of medicines, and also pharmaceutical substances are destroyed by burning;

6) medical immunobiological supplies, are disinfected and destroyed by boiling within 30 minutes (vaccine against anthrax - 2 hours) or immersion in the disinfectant registered and allowed for use in the Republic of Kazakhstan.

7. Destruction of the drugs, psychotropic substances and precursors which are subject to control in the Republic of Kazakhstan is performed according to the legislation of the Republic of Kazakhstan regulating drug trafficking, psychotropic substances and precursors.

8. The destruction of medical equipment and products of medical appointment containing radioactive elements it is performed according to the legislation of the Republic of Kazakhstan in the field of use of atomic energy.

9. Flammable, explosive medicines, radio pharmaceutical medicines, and also medicinal vegetable raw materials with the increased content of radionuclides are destroyed in special conditions on special technology, the available organization, with the corresponding license on their destruction.

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