ORDER OF THE MINISTER OF HEALTH OF THE REPUBLIC OF KAZAKHSTAN

of January 27, 2021 No. KR DSM-11

About approval of rules of marking and traceability of medicines and markings of medical products

According to item 4 of article 242 of the Code of the Republic of Kazakhstan "About health of the people and health care system" and the subitem 2) article 7-2 of the Law of the Republic of Kazakhstan "On regulation of trading activity" PRIKAZYVAYU:

1. Approve:

1) rules of marking and traceability of medicines according to appendix 1 to this order;

2) rules of marking of medical products according to appendix 2 to this order.

2. Recognize invalid:

1) the order of the Minister of health and social development of the Republic of Kazakhstan of April 16, 2015 No. 227 "About approval of Rules of marking of medicines and medical products" (it is registered in the Register of state registration of regulatory legal acts at No. 11088, it is published on June 5, 2015 in information system of law of Ad_let);

2) the order of the Minister of Health of the Republic of Kazakhstan of April 22, 2019 No. KR DSM-44 "About introduction of amendments to some orders of the Ministry of Health of the Republic of Kazakhstan and the Ministry of health and social development of the Republic of Kazakhstan" (it is registered the Register of state registration of regulatory legal acts at No. 18582, it is published on May 2, 2019 in Reference control bank of regulatory legal acts of the Republic of Kazakhstan).

3. To provide to committee of medical and pharmaceutical control of the Ministry of Health of the Republic of Kazakhstan in the procedure established by the legislation of the Republic of Kazakhstan:

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

2) placement of this order on Internet resource of the Ministry of Health of the Republic of Kazakhstan after its official publication;

3) within ten working days after state registration of this order in the Ministry of Justice of the Republic of Kazakhstan submission to Legal department of the Ministry of Health of the Republic of Kazakhstan of data on execution of the actions provided by subitems 1) and 2) of this Item.

4. To impose control of execution of this order on the supervising vice-Minister of Health of the Republic of Kazakhstan.

5. This order becomes effective after ten calendar days after day of its first official publication.

Appendix 1

to the Order of the Minister of Health of the Republic of Kazakhstan of January 27, 2021 No. KR DSM-11

Rules of marking and traceability of medicines

Chapter 1. General provisions

1. These rules of marking and traceability of medicines (further – Rules) are developed according to item 4 of article 242 of the Code of the Republic of Kazakhstan "About health of the people and health care system" (further – the Code) and the subitem 2) of article 7-2 of the Law of the Republic of Kazakhstan "On regulation of trading activity" (further – the Law on regulation of trading activity) and determine procedure for marking and traceability of medicines in the Republic of Kazakhstan.

2. In these rules the following concepts are used:

1) business and identification number (further – BIN) – the unique number created for the legal entity (branch and representation) and the individual entrepreneur performing activities in the form of joint venture;

2) the single distributor – the legal entity performing activities within the guaranteed amount of free medical care (further – GOBMP) and (or) in system of compulsory social medical insurance (further – OSMS) according to article 247 of the Code;

3) authorized body in the field of health care (further – authorized body) – the central executive body performing management and cross-industry coordination in the field of protection of public health of the Republic of Kazakhstan, medical and pharmaceutical science, medical and pharmaceutical education, sanitary and epidemiologic wellbeing of the population, drug circulation and medical products, qualities of rendering medical services (help);

4) medicine balk-product – the dosed ready medicine, the stages of engineering procedure which passed everything, except for final packaging;

5) medicine packaging – means or complex of the means providing process of drug circulation by their protection against damages and losses, and also protecting the environment from pollution.

Packaging consists from primary (internal), intermediate (in the presence), secondary (external or consumer (in the presence)), packaging transport (in the presence):

primary (internal) package – the packaging which is directly adjoining to medicine;

intermediate packaging – packaging in which the primary package for the purpose of additional protection of medicine or proceeding from features of use of medicine is located;

secondary (external or consumer) packaging – packaging in which medicine in primary and intermediate package is located;

shipping package – the packaging uniting sets uniform (within one commodity code of GTIN (GTIN) secondary (and in case of their absence – primary) consumer packagings of the medicines used for storage and transportation for the purpose of protection them from damages when moving and forming independent transport unit. The shipping package includes shipping packages of the smaller size (amount);

6) state body in the sphere of drug circulation and medical products (further – state body) – the state body performing management in the sphere of drug circulation and medical products, control of drug circulation and medical products;

7) the state expert organization in the sphere of drug circulation and medical products (further – the expert organization) – the subject of the state monopoly performing production economic activity in the field of health care on safety, efficiency and qualities of medicines and medical products;

8) subjects in the sphere of drug circulation and medical products – the physical persons or legal entities performing pharmaceutical activities;

9) producer of medicines – the organization which is performing activities for production of medicines and having the license for production of medicines;

10) the trade name of medicine – the name under which medicine is registered;

11) individual identification number (further – IIN) – the unique number created for physical person, including the individual entrepreneur performing activities in the form of personal entrepreneurship;

12) the material carrier – the control (identification) sign or object from any materials which contains or does not contain elements (means) of protection against counterfeit and is intended for drawing, storage and transfer of means of identification;

13) means of identification – the unique sequence of symbols in machine-readable form presented in barcode type, or which is written down on radio-frequency tag, or provided with use of other means (technology) of automatic identification;

14) number of series – the distinctive combination of figures, letters and (or) symbols allowing to identify specifically series of medicine and to determine the complete sequence of production and control operations, and also to trace medicine realization;

15) sticker (sticker) – the data carrier on which marking with information for the consumer in the Kazakh and Russian languages is applied, attached to secondary package by gluing;

16) marking – information placed on the medicine packaging containing including means of identification;

17) the trademark, service mark (further – the trademark) – the designation registered according to the Law of the Republic of Kazakhstan "About trademarks, service marks and names of places of goods origin" or protected without registration owing to international treaties in which the Republic of Kazakhstan participates, serving for difference of goods (services) of one legal entities or physical person from uniform goods (services) of other legal entities or physical persons;

18) information system (further – IS) – the organizational ordered set of the information and communication technologies, service personnel and technical documentation realizing certain technological actions by means of information exchange and intended for the solution of specific functional objectives;

19) the single operator of marking and traceability of goods (further – the Operator) – the legal entity created according to the legislation of the Republic of Kazakhstan, performing development, administration, maintenance and operational support of information system of marking and traceability of goods including development, maintaining and updating of the National catalog of goods, and other functions determined by the Government of the Republic of Kazakhstan;

20) the operator of fiscal data – the legal entity providing transfer of data on cash calculations in the operational mode in tax authorities on networks of telecommunications public, determined by the state body performing management in the sphere of ensuring receipts of taxes and payments in the budget in coordination with authorized body in the sphere of informatization;

21) the digital signature (further – the EDS) – set of electronic digital symbols created by means of the digital signature and confirming reliability of the electronic document, its accessory and invariance of content;

22) traceability of medicines - the organization of accounting of the medicines which are subject to traceability and the transactions connected with their turnover with use of information system of marking and traceability.

3. Prototypes of marking of packagings, labels and stickers on medicines are registered state body in case of state registration of medicine in the Republic of Kazakhstan which is carried out according to Rules of state registration, re-registration of medicine or medical product, modification of the registration file of medicine or the medical product approved by the order of the Minister of Health of the Republic of Kazakhstan of February 9, 2021 No. RR DSM-16 "About approval of rules of state registration, re-registration of medicine or medical product, modification of the registration file of medicine or medical product" (it is registered in the Register of state registration of regulatory legal acts at No. 22175).

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