Comment to article 426. Violation of the rules of pharmaceutical activity and the sphere of circulation of medicines and medical devices The Code of the Republic of Kazakhstan on Administrative Offences
1. Violation of the rules of registration and re-registration, production, manufacture and quality control, testing (research), import, purchase, transportation, storage, labeling, sale, including exceeding the established marginal prices for medicines, as well as the use (use), provision, destruction, advertising of medicines, medical products if it has not caused harm to human health, -
entails a fine for individuals in the amount of seventy, for officials - in the amount of one hundred, for small businesses - in the amount of one hundred and thirty, for medium-sized businesses - in the amount of two hundred, for large businesses - in the amount of one thousand monthly calculation indices.
2. The act provided for in the first part of this article, committed repeatedly within a year after the imposition of an administrative penalty, -
entails suspension of the pharmaceutical activity license for a period of up to six months.
3. Production, purchase, transportation, storage, sale, application (use), advertising of unregistered, unauthorized medicines and medical devices, if they have not caused harm to human health, -
they impose a fine on individuals in the amount of one hundred, on officials - in the amount of one hundred and fifty, on small businesses - in the amount of two hundred, on medium-sized businesses - in the amount of three hundred, on large businesses - in the amount of one thousand five hundred monthly calculation indices, with the suspension of activities, with the confiscation of medicines and equivalent products, therapeutic and preventive nutrition products and food additives, as well as cosmetics that are the direct subjects of an administrative offense and income received as a result of an administrative offense.
4. Acts provided for in parts one and three of this article that have caused harm to human health, if these actions do not contain signs of a criminally punishable act., -
they impose a fine on individuals in the amount of two hundred, on officials - in the amount of three hundred, on small businesses - in the amount of three hundred and fifty, on medium-sized businesses - in the amount of four hundred, on large businesses - in the amount of two thousand monthly calculation indices, with the confiscation of medicines and medical products, therapeutic and preventive nutrition products and food additives, as well as cosmetics that are the direct subjects of an administrative offense and income received as a result of an administrative offense, as well as the prohibition of their activities.
The object of the offense provided for in part 1 of Article 426 is the established procedure for registration and re-registration, circulation, advertising of medicines, medical devices and medical equipment. Compliance with this procedure is directly related to public health issues.
According to paragraph 17 of Article 4 of the Code of the Republic of Kazakhstan "On the Health of the People and the Healthcare system" (hereinafter referred to as the "Code on the Health of the People"), the safety, effectiveness and quality of medical products are attributed to the factors of national security.
Section 4 of the National Health Code (chapters 13, 14, 15) is devoted to issues of pharmaceutical activity and circulation of medicines, medical devices and medical equipment. This section contains numerous rules related to such activities and treatment.
The objective side of this offense is expressed in violation of the rules of registration and re-registration, production, manufacture and quality control, testing (research), import, purchase, transportation, storage, labeling, sale, application (use), provision, destruction, advertising of medicines, medical devices and medical equipment.
Such violations can be expressed in both action and inaction. When qualifying an offense, there is no need to prove harm to human health.
The rules, violations of which are punishable by Part 1 of Article 426 of the Administrative Code, are contained in such acts as:
- Resolution of the Government of the Republic of Kazakhstan dated October 30, 2009 No. 1729 "On approval of the Rules for the organization and procurement of medicines, preventive (immunobiological, diagnostic, disinfecting) drugs, medical devices and medical equipment, pharmaceutical services for the provision of guaranteed free medical care and medical care in the system of compulsory social health insurance."
- Resolution of the Government of the Republic of Kazakhstan dated January 16, 2012 No. 60 "On approval of the Rules for the manufacture of medicines and medical devices".
- Order of the Minister of Health of the Republic of Kazakhstan dated November 18, 2009 No. 735 "On approval of the Rules for State Registration, Re-registration and Amendments to the Registration Dossier of medicines, medical devices and medical equipment".
- Order of the Minister of Health and Social Development of the Republic of Kazakhstan dated November 26, 2014 No. 269 "On approval of the Rules for assessing the safety and Quality of medicines and medical devices registered in the Republic of Kazakhstan".
- Order of the Minister of Health and Social Development of the Republic of Kazakhstan dated February 27, 2015 No. 106 "On approval of the Rules for the prohibition, suspension, withdrawal or Restriction from circulation of medicines, medical devices and medical equipment".
- Order of the Minister of Health and Social Development of the Republic of Kazakhstan dated April 24, 2015 No. 262 "On approval of the Rules for storage and Transportation of medicines, medical devices and medical equipment".
- Order of the Minister of Health and Social Development of the Republic of Kazakhstan dated April 28, 2015 No. 288 "On approval of the Rules for classifying medicines as prescription drugs".
- Order of the Minister of Health and Social Development of the Republic of Kazakhstan dated May 28, 2015 No. 405 "On approval of the Rules for conducting intra-pharmacy control of manufactured medicines".
- Order of the Minister of Health and Social Development of the Republic of Kazakhstan dated August 17, 2015 No. 665 "On approval of the Rules for the import into the territory of the Republic of Kazakhstan of medicines, medical devices and medical equipment and export from the territory of the Republic of Kazakhstan of medicines, medical devices and medical equipment".
- Order of the Minister of Health and Social Development of the Republic of Kazakhstan dated August 25, 2015 No. 680 "On approval of the Rules for Production and Quality Control, as well as stability tests and determination of shelf life and repeated control of medicines, medical devices and medical equipment".
- Order of the Minister of Health and Social Development of the Republic of Kazakhstan dated August 26, 2015 No. 687 "On approval of the Rules for the destruction of medicines, medical devices and medical equipment that have become unusable, falsified, expired".
- Order of the Minister of Health and Social Development of the Republic of Kazakhstan dated September 14, 2015 No. 713 "On approval of the Rules for the Wholesale and Retail sale of medicines, medical devices and medical equipment".
- Order of the Minister of Health and Social Development of the Republic of Kazakhstan dated September 30, 2015 No. 766 "On approval of the rules for providing medicines to citizens".
- Order of the Minister of Health of the Republic of Kazakhstan dated March 16, 2018 No. 112 "On approval of marginal prices for medicines and medical devices within the guaranteed volume of free medical care and compulsory social health insurance".
- Order of the Minister of Health of the Republic of Kazakhstan dated April 2, 2018 No. 142 "On approval of the Rules for conducting Biomedical experiments, Preclinical (non-clinical) and clinical trials, as well as requirements for preclinical and clinical databases."
On the subjective side, the offense is characterized by intent or negligence.
The subject of the offense is an individual, an individual entrepreneur, an official, or a legal entity (business entity).
Part 2 provides for increased responsibility for repeated commission within a year after the imposition of an administrative penalty of the actions provided for in part 1 of the commented article.
The object of the offense provided for in part 3 of Article 426 is also the established procedure for the circulation of medicines, medical devices and medical equipment. However, in this case, we are talking about the circulation of unregistered, unauthorized products and products.
The objective side of the offense is expressed in the commission of various actions (production, purchase, transportation, storage, sale, application (use) advertising in the field of circulation of medicines and medical devices.
In accordance with paragraph 1 of Article 71 of the People's Health Code, the state registration of a medicinal product or medical device is a procedure for determining the legality of its presence on the pharmaceutical market, evaluating the safety, quality and effectiveness of a medicinal product or medical device, and entering a medicinal product or medical device into the State Register of Medicines and Medical Devices for a certain period of time. in accordance with the procedure determined by the authorized body.
The document confirming registration and permission for medical use in the territory of the Republic of Kazakhstan of a medicinal product, medical device and medical equipment is a registration certificate (paragraph 16 of Article 71 of the People's Health Code, paragraph 6 of paragraph 4 of the Rules of State Registration, re-registration and amendments to the registration dossier of medicines, medical devices and medical equipment approved by Resolution of the Government of the Republic of Kazakhstan dated November 18, 2009 No. 735).
Various articles of the Public Health Code prohibit specific types of treatment of unregistered objects (paragraphs 1, paragraph 3, Article 18, paragraph 1, paragraph 4, Article 67, paragraph 1, paragraph 4, Article 69, paragraph 2, Article 80).
When qualifying an offense, there is no need to prove harm to human health.
On the subjective side, the offense is characterized by intent or negligence.
The subject of the offense is an individual, an individual entrepreneur, an official, or a legal entity (business entity).
Part 4 provides for increased responsibility for the commission of acts provided for in Parts 1 and 3 that caused harm to human health, if these actions do not contain signs of a criminally punishable act (see, for example, articles 317, 323 of the Criminal Code). Thus, in addition to actions or omissions, the objective side of the offense in this case will include the onset of socially dangerous consequences in the form of harm to human health and the causal relationship between the act and the consequences.
On the subjective side, the offense is characterized by intent or negligence.
The subject of the offense is an individual, an individual entrepreneur, an official, or a legal entity (business entity).
The protocols on administrative offenses provided for in Article 426 may be drawn up by officials of sanitary and epidemiological surveillance authorities (paragraph 22, part 1 of Article 804), bodies in the field of circulation of medicines and medical devices (paragraph 53, part 1 of Article 804).
Cases of administrative offenses provided for in Part 1 of Article 426 are considered by the state body in the field of circulation of medicines, medical devices and medical equipment and its territorial divisions (part 1 of Article 700); and in parts 2, 3 and 4 of Article 426 - judges of specialized district and equivalent administrative courts (part 1 of Article 684).
Scientific and practical commentary to the Code of the Republic of Kazakhstan on Administrative Offences (article-by-article) from the Author's team:
Bachurin Sergey Nikolaevich, Candidate of Law, Associate Professor – chapter 48 (co-authored with E.M. Khakimov);
Gabdualiev Mereke Trekovich, Candidate of Law – Chapters 11, 21, 22, 23;
Zhusipbekova Ainur Maratovna, M.yu.n. – chapter 13 (co-authored with Karpekin A.V.); chapters 33, 39 (co-authored with Seitzhanov O.T.);
Karpekin Alexander Vladimirovich, Candidate of Law, Associate Professor – chapter 13 (in collaboration with Zhusipbekova A.M.);
Korneychuk Sergey Vasilyevich – chapters 2; chapter 6 (co-authored with O.T. Seitzhanov, E.M. Khakimov); chapter 8; chapter 25 (co-authored with E.M. Khakimov); articles 457-470, 488, 488-1, 491-506; chapters 28, 30, 52;
Ilya Petrovich Koryakin, Doctor of Law, Professor – Chapter 49;
Kisykova Gulnara Bauyrzhanovna, Candidate of Law – chapter 20;
Omarova Botagoz Akimgereevna, Candidate of Law – chapters 17; chapter 18 (co-authored with B.A. Parmankulova); chapters 26, 31; chapter 32 (co-authored with B.A. Parmankulova);
Parmankulova Bayan Askhanbaevna – chapter 18 (co-authored with Omarova B.A.); chapters 19, 32 (co-authored with Omarova B.A.); chapter 43 (co-authored with Tukiev A.S.);
Podoprigora Roman Anatolyevich, Doctor of Law, Professor - Chapter 24, articles 489, 489-1, 490;
Porokhov Evgeny Viktorovich, Doctor of Law – Chapters 14, 15, 16, 29, articles 471-475;
Seitzhanov Olzhas Temirzhanovich, Candidate of Law, Associate Professor, – chapter 4; chapter 5 (co-authored with E. M. Khakimov); chapter 6 (co-authored with S.V. Korneychuk, E.M. Khakimov); chapter 9; chapter 10 (co-authored with B.E. Shaimerdenov, V.V. Filin); chapter 33 (co-authored with Zhusipbekova A.M.); chapter 36 (co-authored with Shaimerdenov B.E.); chapter 39 (co-authored with Zhusipbekova A.M.);
Smyshlyaev Alexander Sergeevich, PhD. – chapters 38, 40, 42, 43-1 (co-authored with A.S. Tukiev); chapter 44;
Aslan Sultanovich Tukiev - Candidate of Law, Associate Professor – chapters 1, 3, 35; chapters 38, 40, 42, (co-authored with A.S. Smyshlyaev); chapter 43 (co-authored with B.A. Parmankulova); chapter 43-1 (co-authored with A.S. Smyshlyaev); chapter 44-1 (co-authored with Shipp D.A.); chapter 45; 46 (co-authored with Shipp D.A.); chapter 47;
Filin Vladimir Vladimirovich, Candidate of Law, Associate Professor – Chapter 10 (in collaboration with O.T. Seitzhanov, B.E. Shaimerdenov);
Yerzhan Maratovich Khakimov, M.yu.n. – chapter 5 (co-authored with O.T. Seitzhanov); chapter 6 (co-authored with O.T. Seitzhanov, S.V. Korneychuk); chapter 7; chapter 25 (co-authored with S.V. Korneychuk); chapters 34, 41; chapter 48 (co-authored with S.N. Bachurin); chapter 53;
Shaimerdenov Bolat Yerkenovich, M.yu.n., – chapter 10 (co-authored with O.T. Seitzhanov, V.V. Filin); chapter 12; articles 476-487, 507-509; chapter 36 (co-authored with O.T. Seitzhanov); chapters 37, 50, 51.
Shipp Denis Alekseevich – chapters 44-1, 46 (in collaboration with A.S. Tukiev).
Date of amendment of the act: 01.01.2020 Date of adoption of the act: 01.01.2020 Place of acceptance: 100050000000 Authority that adopted the act: 103001000000 Region of operation: 100000000000 NPA registration number assigned by the regulatory body: 5 Status of the act: new Sphere of legal relations: 029000000000 / 028000000000 / 029002000000 / 028004000000 / 029001000000 / 026000000000 / 001000000000 / 001008000000 / 030000000000 The form of the act: COMM / CODE Legal force: 1900 Language of the Act: rus
Attention!
Law and Law Law Law draws your attention to the fact that this document is basic and does not always meet the requirements of a particular situation. Our lawyers are ready to assist you in legal advice, drawing up any legal document suitable for your situation.
For more information, please contact a Lawyer / Attorney by phone: +7 (708) 971-78-58; +7 (700) 978 5755, +7 (700) 978 5085.
Attorney at Law Almaty Lawyer Legal Services Legal Advice Civil Criminal Administrative Cases Disputes Protection Arbitration Law Firm Kazakhstan Law Office Court Cases
