Unofficial translation
In accordance with paragraph 4 of Article 250 of the Code of the Republic of Kazakhstan dated July 7, 2020 "On public health and the healthcare system" I HEREBY ORDER:
1. To approve the Rules for the destruction by entities in the field of the circulation of medicines and medical articles, who possesses the medicines and medical articles that have become obsolete and have reached expiry date, counterfeited medicines, and medical products, and other products that do not comply with the requirements of the legislation of the Republic of Kazakhstan.
2. To recognize as terminated:
1) Order of the Minister of Healthcare and Social Development of the Republic of Kazakhstan dated August 26, 2015, No. 687 "On approval of the Rules for the destruction of medicines and medical articles that have become unusable, counterfeited, with an expired shelf life" (registered in the State Registration Register of Regulatory Legal Acts under No. 12122, published on October 6, 2015 in the legal information system Adilet);
2) paragraph 9 of the List of amended orders of the Ministry of Healthcare of the Republic of Kazakhstan and the Ministry of Healthcare and Social Development of the Republic of Kazakhstan, approved by Order of the Minister of Healthcare of the Republic of Kazakhstan dated April 22, 2019 No. ҚР ДСМ-44 "On amendments to some orders of the Ministry of Healthcare Of the Republic of Kazakhstan and the Ministry of Healthcare and Social Development of the Republic of Kazakhstan” (registered in the State Registration Register of Regulatory Legal Acts under No. 18582, published on May 2, 2019 in the Reference Control Bank of the Regulatory Legal Acts of the Republic of Kazakhstan).
3. The Committee for Medical and Pharmaceutical Control of the Ministry of Healthcare of the Republic of Kazakhstan, in accordance with the procedure established by the legislation of the Republic of Kazakhstan, shall ensure:
1) state registration of this Order with the Ministry of Justice of the Republic of Kazakhstan;
2) posting this Order on the Internet resource of the Ministry of Healthcare of the Republic of Kazakhstan after its official publication;
3) within ten working days after the state registration of this Order with the Ministry of Justice of the Republic of Kazakhstan, submission to the Legal Department of the Ministry of Healthcare of the Republic of Kazakhstan the information on the implementation of the measures provided for in subparagraphs 1) and 2) of this paragraph.
4. Control over the execution of this order shall be entrusted to the Supervising Vice Minister of Healthcare of the Republic of Kazakhstan.
5. This Order shall come into effect upon the expiration of ten calendar days after the day of its first official publication.
|
Acting Minister of Healthcare of the Republic of Kazakhstan |
M. Shoranov |
| Approved by Order of the Acting Minister of Healthcare of the Republic of Kazakhstan dated October 27, 2020 No. ҚР ДСМ -155/2020 |
Rules for destruction by entities in the field of the circulation of medicines and medical articles, who possesses the medicines and medical articles that have become obsolete and have reached expiry date, counterfeited medicines, and medical products, and other products that do not comply with the requirements of the legislation of the Republic of Kazakhstan
Chapter 1. General provisions
1. These Rules for destruction by entities in the field of the circulation of medicines and medical articles, who possesses the medicines and medical articles that have become obsolete and have reached expiry date, counterfeited medicines, and medical products, and other products that do not comply with the requirements of the legislation of the Republic of Kazakhstan (hereinafter referred to as the Rules) have been developed in accordance with paragraph 4 of Article 250 of the Code of the Republic of Kazakhstan dated July 7, 2020 "On Public Health and the Healthcare System" and shall determine the procedure for the destruction of medicines and medical devices that have become unusable, expired, falsified and other medicines and medical devices, that do not meet the requirements of the legislation of the Republic of Kazakhstan.
2. The following concepts shall be used in these Rules:
1) destruction of medicines and medical devices - the procedure of exposure (thermal, chemical, mechanical, or other) to medicine and a medical device, excluding the possibility of their further use;
2) entities in the field of circulation of medicines and medical devices (hereinafter referred to as Entities) - individuals or legal entities engaged in pharmaceutical activities;
3) the expiration date of a medicinal product - the date after which the medicinal product may not be used;
4) counterfeit medicines and medical devices - medicines, medical devices, unlawfully and deliberately supplied with inaccurate information about their composition or configuration and (or) manufacturer, as well as about supplies, including records and documents concerning the used supply channels;
5) medicinal products and medical devices unsuitable for sale and medical use - deteriorated, expired, counterfeit and other medicinal products and medical products that do not meet the requirements of the legislation of the Republic of Kazakhstan, the use of which poses a danger to human life and health.
Chapter 2. The procedure for destruction by entities in the field of the circulation of medicines and medical articles, who possesses the medicines and medical articles that have become obsolete and have reached expiry date, counterfeited medicines, and medical products, and other products that do not comply with the requirements of the legislation of the Republic of Kazakhstan
3. The destruction of medicines and medical devices unsuitable for sale and medical use (defect, expiration date) and the destruction of medical devices that have become unusable (physical and moral deterioration, as a result of natural disasters and accidents, breakdown with impossible restoration) shall be carried out directly by the entities in compliance with the requirements of the legislation of the Republic of Kazakhstan in the field of environmental protection and sanitary and epidemiological well-being of the population.
The destruction of medicines and medical devices shall be carried out by a permanent commission, the composition of that shall be approved by the head of the entity (hereinafter referred to as the Commission).
Destruction of medicines and medical devices unsuitable for sale and medical use in the amount of over 300 packages (pieces) shall be carried out through an organization that destroys medicines and medical devices, based on an appropriate contract, in compliance with the requirements of the legislation of the Republic of Kazakhstan in the field of environmental protection and sanitary - the epidemiological well-being of the population.
4. Degraded, falsified, expired medicinal products and medical devices shall be isolated from other products and placed in storage in a specially designated place protected from unauthorized access. Such products shall be marked with the inscription: "Shall not be subject to further use" As medicines and medical devices accumulate, they shall be destroyed at least once a quarter in the presence of the commission.
5. Medicines and medical devices shall be destroyed in the following ways:
1) medical devices shall be destroyed by dismantling, disassembling, mechanical damage, including punching holes, tearing, causing damage in other ways, provided that such damage excludes the subsequent restoration of the medical device and the possibility of their use in their original form unless otherwise specified in the operational document of the medical products developed by the manufacturer, as well as by incineration unless otherwise specified in the instructions for medical use of a medical device developed by the manufacturer;
2) liquid dosage forms (solutions for injections in ampoules, in bags and in vials, medicines, drops, liquids in aerosol cans) are destroyed by crushing, followed by dilution of the contents with water in a ratio of 1: 100 and draining the resulting solution into the industrial sewer (in aerosol holes are pre-made in cylinders), the remains of ampoules, aerosol cans, bags and bottles are taken out and destroyed by disposal;
3) solid dosage forms (powders, tablets, capsules) containing water-soluble substances of medicinal products, after crushing to a powdery state, are to be diluted with water in a ratio of 1: 100 and drained into the industrial sewer;
4) solid dosage forms (powders, tablets, capsules) containing drug substances insoluble in water, soft dosage forms (ointments, suppositories), transdermal forms of medicines, as well as pharmaceutical substances are destroyed by burning;
5) medical immunobiological preparations are disinfected and destroyed by boiling for 30 minutes (anthrax vaccines - 2 hours) or by immersion in a disinfectant registered and approved for use in the Republic of Kazakhstan.
6. The destruction of narcotic medicines, psychotropic substances and precursors subject to control in the Republic of Kazakhstan shall be carried out in accordance with paragraph 2 of Article 21 of the Law of the Republic of Kazakhstan dated July 10, 1998 "On narcotic medicines, psychotropic substances, their analogs and precursors and measures to counter their illegal turnover and abuse”.
7. The destruction of medical devices containing radioactive elements shall be carried out in accordance with the Law of the Republic of Kazakhstan dated January 12, 2016 "On the use of atomic energy".
8. Flammable, explosive medicinal products, radiopharmaceutical medicinal products, as well as medicinal plant materials with increased content of radionuclides are destroyed under conditions that exclude environmental pollution and impact on the health of personnel and population.
9. In the event of the destruction of medicines and medical devices unsuitable for sale and medical use, an act on the destruction of medicines and medical devices unsuitable for sale and medical use (hereinafter referred to as the act) shall be drawn up in the form in accordance with the appendix to these Rules.
The act is drawn up on the day of the destruction of medicines and medical devices.
The act is drawn up in triplicate and signed by all persons who took part in the destruction of medicines and medical devices. If the destruction of medicines and medical devices shall be carried out by an organization, the act is additionally certified by its seal (if any).
One copy of the act within 5 (five) working days from the date of its drawing up is sent by the subject to the appropriate territorial subdivision of the state body in the field of circulation of medicines and medical devices.
10. In the event that medicines and medical devices imported into the territory of the Republic of Kazakhstan are recognized as unsuitable for sale and medical use at the stage of customs clearance, such medicines and medical products are exported outside the Republic of Kazakhstan or placed under the customs regime for the destruction of goods in accordance with the Code Of the Republic of Kazakhstan dated December 26, 2017 "On customs regulation in the Republic of Kazakhstan".
The act on the destruction of medicines and medical devices unsuitable for sale and medical use
"_____" __________ _____ year, ____ (time) ______________________ (date) (place of destruction)
We: _______________________________________________________________
(last name, first name, patronymic (if any), place of work, the position of the persons who took part in the destruction)
destroyed the following medicines and medical devices, unsuitable for sale
and medical use in the amount of ______ names in the amount of ____ tenge, about which present act:
No. | The name of the medicine and medical device | Pharmaceutical form, dosage | Series (model) | Unit of measurement | Price (KZT) | Amount | Amount (KZT) | Name of the manufacturer of the medicine, medical device | The basis for destruction/reason for the destruction | Method of destruction |
Signatures: ___________ Surname, name, patronymic (if any) of the persons who took
part in the destruction.
Place of stamp (if any)
for organizations engaged in the destruction of medicines and medical devices.
