ORDER OF THE MINISTER OF HEALTH OF THE REPUBLIC OF KAZAKHSTAN

of May 30, 2022 No. KR DSM-49

About introduction of amendments to the 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 of medicines and medical products"

I ORDER:

1. Bring in the 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 of medicines and medical products" (it is registered in the Register of state registration of regulatory legal acts at No. 22146) the following changes:

state heading in the following edition:

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

state preamble in the following edition:

"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) of article 7-2 of the Law of the Republic of Kazakhstan "On regulation of trading activity" I ORDER:";

state Item 1 in the following edition:

"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.";

The rules of marking of medicines approved by appendix 1 to the specified order to be reworded as follows according to appendix to this order.

2. 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.

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

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

Appendix

to the Order of the Minister of Health of the Republic of Kazakhstan of May 30, 2022 No. KR DSM-49

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

shipping package – the packaging combining sets homogeneous (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 field of drug circulation and medical products (further – state body) – the state body performing management in the field of drug circulation and medical products, control of drug circulation and medical products;

7) the state expert organization in the field 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 field 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;

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