Comment to article 432. Provision of deliberately false information and information when obtaining permits to engage in medical and pharmaceutical activities of the Code of the Republic of Kazakhstan on Administrative Offenses
1. Providing deliberately false information and information when obtaining permits to engage in medical and pharmaceutical activities, including through falsification of documents, if this action does not contain signs of a criminally punishable act, –
entails a fine for individuals in the amount of ten, for officials, small business entities – in the amount of fifteen, for medium–sized businesses – in the amount of twenty, for large businesses - in the amount of thirty monthly calculation indices.
2. The same act committed repeatedly within a year after the imposition of an administrative penalty, –
entails a fine for individuals in the amount of twenty, for officials, small business entities – in the amount of thirty, for medium–sized businesses – in the amount of forty, for large businesses - in the amount of sixty monthly calculation indices.
The object of the offense provided for in article 432 is the established procedure for obtaining permits to engage in medical and pharmaceutical activities. Failure to comply with this procedure may have negative consequences for public health.
In accordance with the legislation of the Republic of Kazakhstan, various types of activities in the field of healthcare are associated with the need to obtain permits.
For example, in accordance with article 13 of the Code of the Republic of Kazakhstan dated September 18, 2009 "On the Health of the People and the Healthcare System" (hereinafter referred to as the "Code on the Health of the People"), medical and pharmaceutical activities are subject to licensing in accordance with the procedure established by the legislation of the Republic of Kazakhstan on permits and notifications.
Currently, licenses are a type of permits, the status of which is regulated by the Law of the Republic of Kazakhstan dated May 16, 2014 "On Permits and Notifications". In accordance with paragraph 15, Article 1 of this law, a permit is a confirmation of the right of an individual or legal entity to carry out activities or actions (operations) carried out by licensing authorities through licensing or a permitting procedure.
In addition to licensing, the People's Health Code contains provisions for other permits.
Thus, in accordance with paragraph 3 of Article 80 of the Code, in certain cases, it is allowed to import medicines and medical devices not registered in the Republic of Kazakhstan on the basis of an opinion (authorization document) issued by an authorized body.
In accordance with paragraph 4 of Article 172 of the Code, the import into the territory of the Republic of Kazakhstan and export from the territory of the Republic of Kazakhstan of hematopoietic stem cells of human bone marrow in the case of their transfer for the purpose of unrelated transplantation are carried out on the basis of a conclusion (authorization document) issued by the authorized body.
Permits are required for conducting preclinical (non-clinical) studies of biologically active substances, clinical studies of medical technologies, clinical trials of pharmacological or medicinal products, medical devices or medical equipment, etc.
Obtaining permits is regulated by the relevant regulatory legal acts. For example:
- Order of the Minister of Health and Social Development of the Republic of Kazakhstan dated January 23, 2015 No. 27 "On approval of qualification requirements for medical and pharmaceutical activities".
- Order of the Minister of Health and Social Development of the Republic of Kazakhstan dated April 28, 2015 No. 293, which approved the Standards of state services in the field of pharmaceutical activity: "Issuance of approval and (or) conclusion (authorization document) for the import (export) of medicines, medical devices and medical equipment registered and not registered in the Republic of Kazakhstan", "Issuance of a license for pharmaceutical activities", "Issuance of a license for the implementation of activities in the sphere of trafficking in narcotic drugs, psychotropic substances and precursors in the field of healthcare", "Granting permission to conduct clinical trials and (or) trials of pharmacological and medicinal products, medical devices and medical equipment", etc.
- Order of the Minister of Health and Social Development of the Republic of Kazakhstan dated April 28, 2015 No. 294, which approved the Standards of public services in the field of medical activity: "Issuance of a license for medical activity", "Issuance of a license for the import into and (or) export from the territory of the Republic of Kazakhstan of organs (parts of organs) and (or) human tissues, blood and its components", "Issuance of an opinion (authorization document) for the import into the territory of the Republic of Kazakhstan and export from the territory of the Republic of Kazakhstan of hematopoietic stem cells, bone marrow in case of their transfer for the purpose of unrelated transplantation, as well as cell samples, tissues, biological fluids and secretions, including human waste products, physiological and pathological secretions, smears, scrapings, flushes intended for diagnostic purposes or obtained in the course of biomedical research", "Granting permission to conduct clinical trials of medical technologies", etc.
These acts provide provisions on the provision of relevant documents and information that must be reliable.
The objective side of this offense is expressed in the provision of deliberately false information when obtaining permits (false information about staff education or overestimated availability of medical equipment, etc.). One of the ways to commit an offense is falsification of documents (changing the date, correcting the document, etc.).
For qualification under article 432, the absence of signs of a criminally punishable act in a person's actions is necessary. For example, in accordance with Article 385 of the Criminal Code, forgery of a certificate or other official document granting rights or relieving of duties, production of forged stamps, seals, letterheads, and the use of a deliberately forged document are punishable.
On the subjective side, the offense is characterized by intent. The person is aware that he is presenting deliberately false information and information.
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 providing deliberately false information repeatedly within a year after the imposition of an administrative penalty.
The protocols on administrative offences provided for in Article 432 may be drawn up by officials of the state body in the field of circulation of medicines and medical devices and its territorial subdivisions and the state body for control in the field of medical services and its territorial subdivisions (Part 3 of Article 804).
Cases of administrative offences provided for in Article 432 are considered by the internal affairs bodies (part 1 of Article 685); the state body in the field of circulation of medicines and medical devices and its territorial divisions (part 2 of Article 700); the state body for control in the field of medical services and its territorial divisions (part 3 of Article 700).
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.);
Alexander Vladimirovich Karpekin, Candidate of Law, Associate Professor – chapter 13 (in collaboration with A.M. Zhusipbekova);
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
