ORDER OF THE MINISTER OF HEALTH AND SOCIAL DEVELOPMENT OF THE REPUBLIC OF KAZAKHSTAN

of August 26, 2015 No. 687

About approval of Rules of destruction of the medicines and medical products which became useless, counterfeited, expired

According to Articles 79 and Item 2 of article 84-1 of the Code of the Republic of Kazakhstan of September 18, 2009 "About health of the people and health care system" I ORDER:

1. Approve the enclosed Rules of destruction of the medicines and medical products which became useless counterfeited, expired.

2. To provide to committee of control of medical and pharmaceutical activities of the Ministry of health and social development of the Republic of Kazakhstan:

1) state registration of this order in the Ministry of Justice of the Republic of Kazakhstan;

2) within ten calendar days after state registration of this order in the Ministry of Justice of the Republic of Kazakhstan the direction on official publication in periodic printing editions and information system of law of Ad_let;

3) placement of this order on Internet resource of the Ministry of health and social development of the Republic of Kazakhstan;

4) within ten working days after state registration of this order in the Ministry of Justice of the Republic of Kazakhstan submission to Department of legal service of the Ministry of health and social development of the Republic of Kazakhstan of data on execution of the actions provided by subitems 1), 2) and 3) of this Item.

3. To impose control of execution of this order on the vice-Minister of health and social development of the Republic of Kazakhstan Tsoi A. V.

4. This order becomes effective after day of its first official publication.

Approved by the Order of the Minister of health and social development of the Republic of Kazakhstan of August 26, 2015 No. 687

Rules of destruction of the medicines and medical products which became useless counterfeited, expired

Chapter 1. General provisions

1. These rules of destruction of the medicines and medical products which became useless counterfeited, expired (further - Rules) are developed according to Articles 79 and Item 2 of article 84-1 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 the medicines and medical products which became useless counterfeited, expired.

2. In these rules the following concepts are used:

1) medicines and medical products, unsuitable to realization and medical application, - counterfeited, expired and other, non-compliant to the requirements legislations of the Republic of Kazakhstan medicines and medical products which application constitutes danger of life and to health of the person;

2) counterfeited medicine and medical product - medicine and medical product, illegally and purposely supplied with unreliable information and the counterfeit label about their structure or picking and (or) the producer, and also is reserved made;

3) expiration date of medicine and medical product - date after which expiration medicine and medical product are not subject to application;

4) destruction of medicines and medical products - the procedure of impact (thermal, chemical, mechanical or other) on the medicine and medical product excluding possibility of their further use;

5) the organization of health care - the legal entity performing activities in the field of health care;

6) subjects in the field of drug circulation and medical products (further - subjects) - the physical persons or legal entities performing pharmaceutical activities.

Chapter 2. Procedure for destruction of the medicines and medical products which became useless counterfeited, expired

3. Destruction unsuitable to realization and medical application of medicines and medical products in quantity to 300 packagings (pieces) (scrap, expiry date) and destruction of the medical products which became useless (physical and obsolescence, as a result of natural disasters and accidents, breakdown with impossible recovery) is performed directly by the subject and the organization of health care.

Destruction of medicines and medical products is performed by the commission which structure affirms the subject's head.

Destruction unsuitable to realization and medical application of medicines and medical products in number of over 300 packagings (pieces) is carried out through the organization performing destruction of medicines and medical products based on the relevant agreement, on specially equipped platforms, polygons and in specially equipped rooms.

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

5. Medicines and medical products are destroyed by the following methods:

1) medical products are destroyed by dismantle, disassembly, mechanical damage, including punching of holes, gaps, drawing damages by different ways provided that such damages exclude the subsequent recovery of medical product and possibility of their use in original form if other is not established in the operational document of medical product developed by the manufacturing organization and also by burning if other is not established in the instruction on medical application of medical product developed by the manufacturing organization;

2) 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 to draining 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 by utilization;

3) 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 to draining in the industrial sewerage;

4) 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;

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

6. Destruction of the drugs, psychotropic substances and precursors which are subject to control in the Republic of Kazakhstan is performed according to Item 2 of article 21 of the Law of the Republic of Kazakhstan of July 10, 1998 "About drugs, psychotropic substances, their analogs and precursors and measures of counteraction to their illicit trafficking and abuse of them".

7. Destruction of the medical products containing radioactive elements is performed according to the Law of the Republic of Kazakhstan of April 14, 1997 "About use of atomic energy".

8. 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 performing destruction of medicines and medical products.

9. In case of destruction unsuitable to realization and medical application of medicines and medical products the statement of destruction unsuitable to realization and medical application of medicines and medical products (further - the Act) in form according to appendix, to these rules is drawn up.

The statement is drawn up in day of destruction of medicines and medical products.

The statement is drawn up in triplicate and signed by all persons who were taking part in destruction of medicines and medical products. If destruction of medicines and medical products is performed by the organization, the Act is in addition certified it by seal (in the presence).

One copy of the Act within 5 working days from the date of its creation goes the subject to the relevant territorial Department of Committee of pharmacy of the Ministry of Health of the Republic of Kazakhstan.

10. If medicines and medical products, portable on the territory of the Republic of Kazakhstan, are acknowledged unsuitable to realization and medical application at stage of customs clearance, such medicines and medical products are exported out of limits of the Republic of Kazakhstan or are located under customs regime of destruction of goods according to the Code of the Republic of Kazakhstan of June 30, 2010 "About customs affairs in the Republic of Kazakhstan".

Appendix

to Rules of destruction of the medicines and medical products which became useless counterfeited, expired

Form

The act of destruction of the medicines and medical products which became useless counterfeited, expired

"_____" __________ _____ of year, ____ (hour) _______________________

     (date, time) (                                      place of destruction)

Us: _______________________________________________________________

     (surname, name, middle name (in case of its availability), place of employment, position

                      persons who were taking part in destruction)

the following medicines and medical products unsuitable to realization and medical application in quantity ______ names are destroyed

on the amount ____ tenge about what this statement is drawn up:

Signatures: ___________ the Surname, name, middle name (in case of its availability) persons who were taking part in destruction.

Locus sigilli (in the presence)

for the organizations performing destruction of medicines and medical products".

Disclaimer! This text was translated by AI translator and is not a valid juridical document. No warranty. No claim. More info