ORDER OF THE MINISTER OF HEALTH OF THE REPUBLIC OF KAZAKHSTAN

of June 19, 2024 No. 22

About modification and amendments 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 and traceability of medicines and markings of 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 and traceability of medicines and markings of medical products" (it is registered in the Register of state registration of regulatory legal acts at No. 22146) the following changes and amendments:

in Rules of marking and traceability of the medicines approved by appendix 1 to the specified order:

2) and 3) of Item 6 to state subitems in the following edition:

"2) when importing medicines, including when importing of the registered and unregistered medicines in the Republic of Kazakhstan imported according to Rules of import to the territory of the Republic of Kazakhstan of medicines and medical products and rendering the state service "Issue of Approval and (or) the Conclusion (the Allowing Document) for Import (Export) of the Medicines Registered and Not Registered in the Republic of Kazakhstan and Medical Products" No. KR DSM-237/2020 approved by appendix 1 to the order of the Minister of Health of the Republic of Kazakhstan of December 8, 2020 "About approval of Rules of import to the territory of the Republic of Kazakhstan and export from the territory of the Republic of Kazakhstan of medicines and medical products and rendering the state service "Issue of Approval and (or) the Conclusion (the Allowing Document) for Import (Export) of the Medicines Registered and Not Registered in the Republic of Kazakhstan and Medical Products" (it is registered in the Register of state registration of regulatory legal acts at No. 21749) (further – Rules of import) to the territory of the Republic of Kazakhstan from the territory of the states which are not state members of the Eurasian Economic Union – in the territory of the third countries, before import to the territory of the Republic of Kazakhstan, on the customs warehouses which are pharmaceutical (distributor) warehouses to the room under customs procedures of release for internal consumption or reimport, or in pharmaceutical (distributor) warehouses, after their room under customs procedures of release for internal consumption or reimport;

3) when importing medicines to the territory of the Republic of Kazakhstan from the territory of state members of the Eurasian Economic Union – outside frontier of the Republic of Kazakhstan, including when importing of the medicines registered and not registered in the Republic of Kazakhstan imported according to Rules of import on the customs warehouses which are pharmaceutical (distributor) warehouses to the room under customs procedures of release for internal consumption or reimport or in pharmaceutical (distributor) warehouses, after their room under customs procedures of release for internal consumption or reimport.";

state Item 32 in the following edition:

"32. Means of identification of medicine, contains the marking code representing the unique sequence of symbols, including 4 groups of the data identified by the application codes provided by the standard of the international organization in the field of standardization of accounting and bar coding of logistic units of GS1 (GS1) Data Matrix (Date matrix).

At the same time at the beginning of line of code of marking there is sign of symbolics of format of barcode of the international organization in the field of standardization of accounting and bar coding of logistic units of GS1 (GS1), FNC1 (SFS1), ASC232 (ASK 232).

The first 2 groups of data of code of marking form code of identification of goods:

the first group is identified by code of application 01 and contains the commodity code of GTIN (GTIN) of consumer packaging consisting of 14 figures;

the second group is identified by code of application 21 and contains the individual serial number of consumer packaging of medicines consisting of 13 symbols of the digital or alphanumeric sequence (letters of the Latin alphabet). As completion for this group the special symbol divider of GS having code 29 in the table of ASCII (ACKII) symbols or symbol function 1, FNC having code 232 in the table of ASCII (ACKII) symbols is used;

The code of check of code of marking is formed by the third and fourth group of data:

the third group is identified by code of application 91 and contains the identifier (individual sequence number) of check key consisting of 4 symbols (figures, lowercase and capital letters of the Latin alphabet), created by the Operator as a part of check code. As completion for this group the special symbol divider of GS having code 29 in the table of ASCII (ACKII) symbols or symbol function 1, FNC having code 232 in the table of ASCII (ACKII) symbols is used;

the fourth group of data is identified by code of application 92 and contains check code value, consisting of 44 symbols (figures, lowercase and capital letters of the Latin alphabet, and also special symbols), created by the Operator as a part of check code.";

2) of Item 55 to state the subitem in the following edition:

"2) customs warehouses.";

state Item 57 in the following edition:

"57. UOLS before input in medicine turnover in the territory of the Republic of Kazakhstan makes aggregation of packagings of the medicines having one commodity code of GTIN (GTIN) in shipping package and also shipping packages of medicines in shipping package of higher level with preserving information on interrelation of codes of identification of each enclosed packaging with code of identification of the created packaging for the purpose of ensuring traceability of circulation of medicines on goods distribution chain without the need for opening of the created shipping package.";

add with Items 57-1 and 57-2 of the following content:

"57-1. UOLS in the territory of the Republic of Kazakhstan makes aggregation of packagings of the medicines having one or several commodity codes of GTIN (GTIN) in shipping package and also shipping packages of medicines in shipping package of higher level with creation of new code of identification of shipping package, and also code of identification of shipping package of higher level with providing information on interrelation of codes of identification of each enclosed packaging with code of identification of the created shipping package for the purpose of ensuring traceability of circulation of medicines on goods distribution chain without the need for opening of the created shipping package.

UOLS before transfer of aggregative packaging to the following UOLS provides in IS MPT information on aggregation of packagings on form according to appendix 6 to these rules. Transfer of UOLS of data on shipping package is considered to equivalent transfer of data on the consumer packagings containing in this shipping package according to IS MPT.

57-2. UOLS in the territory of the Republic of Kazakhstan makes aggregation of packagings of medicines by withdrawal or investment of packagings of the medicines having one or several commodity codes of GTIN (GTIN) in shipping package and also shipping packages of medicines in shipping package of higher level with preserving code of identification of shipping package and information on interrelation of codes of identification of each enclosed packaging with code of identification of the created packaging for the purpose of ensuring traceability of circulation of medicines on goods distribution chain without the need for opening of the created shipping package.

UOLS before transfer of aggregative packaging to the following UOLS provides in IS MPT information on aggregation of packagings on form according to appendix 7 to these rules. Transfer of UOLS of data on shipping package is considered to equivalent transfer of data on the consumer packagings containing in this shipping package according to IS MPT.";

state Items 58 and 59 in the following edition:

"58. In case of representation of UOLS in IS MPT of data on turnover or conclusion from turnover of part of the marked medicines which are in shipping package in IS MPT disbandment of the shipping package containing the withdrawn medicines in case of lack of aggregation automatically is registered.

59. In case of turn of medicines in other shipping package provision of data on aggregation in IS MPT is performed according to the requirements provided by Items 57, 57-1, 57-2 and 58 of these rules.";

state Items 67 and 68 in the following edition:

"67. UOLS performing import of medicines to the Republic of Kazakhstan from the territories of state members of the Eurasian Economic Union before crossing of Frontier of the Republic of Kazakhstan create the notification on commodity importation to the Republic of Kazakhstan from the territories of state members of the Eurasian Economic Union in form according to appendix 9 to these rules, sign its EDS and send to IS MPT for receipt of registration number.

Upon acceptance on the importer's warehouse in the Republic of Kazakhstan of the imported UOLS medicines sends to IS MPT of the data on confirmation of the codes of identification declared to them earlier in the notification on commodity importation to the Republic of Kazakhstan from the territories of state members of the Eurasian Economic Union.

68. UOLS performing import of medicines to the Republic of Kazakhstan from the territories of the states which are not members of the Eurasian Economic Union, upon acceptance on the importer's warehouse in the Republic of Kazakhstan of the imported medicines create the notification on commodity importation to the Republic of Kazakhstan from the territories of the states which are not members of the Eurasian Economic Union in form according to appendix 10 to these rules, sign it by means of the EDS and send to IS MPT for receipt of registration number.";

state Item 71 in the following edition:

"71. In case of realization and (or) transfer of the medicines marked by means of identification to other UOLS the sender of medicines creates the acceptance report (transfers) of goods in form according to appendix 11 to these rules, signs its EDS and sends to IS MPT for receipt of registration number, no later than day of realization of medicines in time.

In case of realization and (or) transfer of the medicines marked by means of identification by the Single distributor within GOBMP and (or) in the OSMS system the acceptance report (transfers) of medicines is created and signed by authorized representatives of the logistic companies rendering to the Single distributor of service in storage and transportation of medicines under the agreement of civil nature based on the power of attorney issued by the Single distributor, data on which contain in IS MPT.";

add with Items 71-1, 71-2 and 71-3 of the following content:

"71-1. By transfer of the medicines marked by means of identification between the geographically distributed divisions of UOLS having one BIN, the sender of medicines creates the act of internal transfer in form according to appendix 12 to these rules, signs its EDS and sends to IS MPT for receipt of registration number, no later than day of realization of medicines in time.

71-2. In case of realization and (or) transfer of the medicines marked by means of identification, to the Single distributor and also from the Single distributor in the medical organization within GOBMP and (or) in the OSMS, UOLS system or authorized representatives of the logistic companies rendering to the Single distributor of service in storage and transportation of medicines under the agreement of civil nature based on the power of attorney issued by the Single distributor, data on which contain in IS MPT, create the acceptance report (transfers) of the Single distributor in form according to appendix 13 to these rules, sign it by means of the EDS and send to IS MPT for receipt of registration number, no later than day of realization of medicines in time.

71-3. By transfer of the medicines marked by means of identification, between branches and (or) representative offices of the logistic companies which are rendering to the Single distributor of service in storage and transportation of medicines under the agreement of civil nature, based on the power of attorney issued by the Single distributor, data on which contain in IS MPT, having one BIN, the sender of medicines creates the act of internal transfer of the Single distributor in form according to appendix 14 to these rules, signs it by means of the EDS and sends to IS MPT for receipt of registration number, no later than day of realization of medicines in time.";

state Items 85 and 86 in the following edition:

"85. The subject in the field of drug circulation and medical products no later than 3 (three) working days following behind day of conclusion of medicines from turnover represents to IS MPT the notification on conclusion from turnover in form according to appendix 15 to these rules in case of conclusion of medicines from turnover for the reasons:

1) scrap;

2) losses;

3) damages;

4) destructions;

5) uses for own needs of the company;

6) sampling;

7) for medical appointment;

8) leaves, according to the free recipe;

9) confiscations.

86. For repeated input in circulation of medicines, the these rules which are earlier removed from turnover for the reasons, specified in Item 85, the medicines except for used for delivery of health care, and also leave of medicines according to recipes issued within GOBMP and (or) the OSMS, UOLS system sends to the Operator the notification on repeated input to circulation of medicines in form according to appendix 16 to these rules.";

6, of 7, of 8, of 9, and 10 to be reworded as follows appendices according to appendices 1, of 2, of 3, 4 and 5 to this order;

add with appendices 11, of 12, of 13, of 14, 15 and 16 according to appendices 6, of 7, of 8, of 9, 10 and 11 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 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 June 19, 2024 No. 22

Appendix 6

to Rules of marking and traceability of medicines form

New aggregation out of production

1. Information about participants of circulation of medicines (General data):

IIN or BIN or INN _______________________

2. Data of the aggregate:

№	Identification code of unit of aggregation	Array of the added marking codes
1.	2	3
2.
…

Note:

IIN – Individual identification number;

BIN – Business identification number;

INN – Individual taxpayer number.

Appendix 2

to the Order of the Minister of Health of the Republic of Kazakhstan of June 19, 2024 No. 22

 Appendix 7

to Rules of marking and traceability of medicines form

Editing aggregation out of production

1. Information about participants of circulation of medicines (General data):

IIN or BIN or INN ________________________

2. Data of the aggregate:

№	Identification code of unit of aggregation	Array of excludable codes of marking	Array of the added marking codes
1.	2	3	4
2.
…

Note:

IIN – Individual identification number;

BIN – Business identification number;

INN – Individual taxpayer number.

Appendix 3

to the Order of the Minister of Health of the Republic of Kazakhstan of June 19, 2024 No. 22

 Appendix 8

to Rules of marking and traceability of medicines form

The report about transfers of codes of identification from the nonresident of the Republic of Kazakhstan

General information

1. BIN, name, sender's address: _______________________

2. BIN name, receiver's address: _________________________

The report about transfers of codes of identification from the nonresident of the Republic of Kazakhstan

3. Shipping date: ____________________

4. Country of shipment: ___________________

5. Information on drugs:

№	Code of identification of goods / packaging
1	2

6. Information on results:

№ of payment order	Commodity code of GTIN (GTIN)	Number of consumer packagings	Name
1	2	3	4

Note:

BIN – Business identification number;

GTIN – Global commodity identification number.

Appendix 4

to the Order of the Minister of Health of the Republic of Kazakhstan of June 19, 2024 No. 22

 Appendix 9

to Rules of marking and traceability of medicines form

The notification on commodity importation from the territories of state members of the Eurasian Economic Union

General information

1. BIN, name, receiver's address: __________________________

2. BIN отправителя*: ___________________________________________

3. Name отправителя*: ___________________________________

4. Country отправитель*: _________________________________________

Paper format

Data on the notification which is written out on paper

  Number of the notification: _____________________________________

 Date of the notification on import: ________________________________

5. Note: ________________________________________________

6. Information on drugs:

№	Commodity code of GTIN (GTIN)	Description of goods	Dosage	Measurement unit.	Dosage form	Code of identification of goods / packaging	Aggregate code	Expiration date	Number of batch/a series	Name of the company	The price for packaging
1	2	3	4	5	6	7	8	9	10	11	12

14. Information on results:

№ of payment order	Commodity code of GTIN (GTIN)	Number of consumer packagings	Name
1	2	3	4

Note: * it is specified in case of input of data according to the notification, written out earlier on paper;

BIN – Business identification number;

GTIN – Global commodity identification number.

Appendix 5

to the Order of the Minister of Health of the Republic of Kazakhstan of June 19, 2024 No. 22

 Appendix 10

to Rules of marking and traceability of medicines form

The notification on import from the third countries No. ___ from ___

General information

1. BIN, name, receiver's address: ________________________

2. Country экспорта*: __________________________________________

Data on the document of customs clearance

3. Type документа*: ___________________________________________

4. Registration number документа*: __________________________

5. Registration date документа*: ________________________________

Data on the decision of customs authority

6. Code accepted решения*: ____________________________________

7. Date решения*: ____________________________________________

8. Code customs органа*: ___________________________________

Data on the document, confirming compliance of goods

9. Type документа*: ___________________________________________

10. Number документа*: ________________________________________

11. Date документа*: __________________________________________

Paper format

Data on the notification which is written out on paper

 Number of the notification: _____________________________________

 Date of the notification on import: ________________________________

12. Note: ______________________________________________

13. Information on drugs:

№	Commodity code (GTIN)	Description of goods	Dosage	Measurement unit.	Dosage form	Code of identification of goods / packaging	Aggregate code	Expiration date	Batch number	Name of the company	The price for packaging
1	2	3	4	5	6	7	8	9	10	11	12

14. Information on results:

№ of payment order	Commodity code of GTIN (GTIN)	Number of consumer packagings	Name
1	2	3	4

Note: * it is specified in case of input of data according to the notification, written out earlier on paper;

BIN – Business identification number;

GTIN – Global commodity identification number.

Appendix 6

to the Order of the Minister of Health of the Republic of Kazakhstan of June 19, 2024 No. 22

 Appendix 11

to Rules of marking and traceability of medicines form

Acceptance report (transfers)

General information

1. BIN, name, sender's address: _____________________

2. BIN, name, receiver's address: ______________________

Paper format

 Number of the source document: ___________________________

 Date of the source document: _____________________________

3. Note: _____________________________________________

4. Information on drugs:

№	GTIN commodity code (GTIN)	Description of goods	Dosage	Measurement unit.	Dosage form	Code of identification of goods / packaging	Aggregate code	Expiration date	Number of batch/a series	Name of the company	The price for packaging
1	2	3	4		5	6	7	8	9	10	11

5. Information on results:

№ of payment order	Commodity code of GTIN (GTIN)	Number of consumer packagings	Name
1	2	3	4

Note:

* it is specified in case of input of data under the acceptance report (transfer), written out earlier on paper;

BIN – Business identification number;

GTIN – Global commodity identification number.

Appendix 7

to the Order of the Minister of Health of the Republic of Kazakhstan of June 19, 2024 No. 22

 Appendix 12

to Rules of marking and traceability of medicines form

Act of internal transfer

General information

1. BIN, name, sender's address: ______________________

2. BIN, name, receiver's address: _______________________

Paper format

 Number of the source document: ___________________________

 Date of the source document: _____________________________

3. Note: _____________________________________________

4. Information on drugs:

№	GTIN commodity code (GTIN)	Description of goods	Dosage	Measurement unit.	Dosage form	Code of identification of goods / packaging	Aggregate code	Expiration date	Number of batch / series	Name of the company	The price for packaging
1	2	3	4	5	6	7	8	9	10	11	12

5. Information on results:

№ of payment order	Commodity code of GTIN (GTIN)	Number of consumer packagings	Name
1	2	3	4

Note:

* it is specified in case of input of data under the act of the internal transfer which is written out earlier on paper;

BIN – Business identification number;

GTIN – Global commodity identification number.

Appendix 8

to the Order of the Minister of Health of the Republic of Kazakhstan of June 19, 2024 No. 22

 Appendix 13

to Rules of marking and traceability of medicines form

Acceptance report (transfers) of the Single distributor

General information

1. BIN, name, sender's address: ____________________

2. BIN, name, receiver's address: _____________________

Information on the organization

3. BIN *: __________________________________________________

4. Наименование*: _________________________________________

5. Адрес*: _________________________________________________

Paper format

 Number of the source document: ___________________________

 Date of the source document: ____________________________

6. Note: _____________________________________________

7. Information on drugs:

№	Commodity code of GTIN (GTIN)	Description of goods	Dosage	Unit. -ism.	Dosage form	Code of identification of goods / packaging	Aggregate code	Expiration date	Number of batch/a series	Name of the company	The price for packaging
1	2	3	4	5	6	7	8	9	10	11	12

8. Information on results:

№ of payment order	Commodity code of GTIN (GTIN)	Number of consumer packagings	Name
1	2	3	4

Note:

* it is specified in case of input of data under the acceptance report (transfer) of the marked goods of the Single distributor who is written out earlier on paper;

BIN – Business identification number;

GTIN – Global commodity identification number.

Appendix 9

to the Order of the Minister of Health of the Republic of Kazakhstan of June 19, 2024 No. 22

 Appendix 14

to Rules of marking and traceability of medicines form

Act of internal transfer of the Single distributor

General information

1. BIN, name, sender's address: ____________________

2. BIN, name, receiver's address: _____________________

Information on the organization

3. BIN *: _________________________________________________

4. Наименование*: _________________________________________

5. Адрес*: ________________________________________________

Paper format

Data on the notification which is written out on paper

 Number of the source document: ___________________________

 Date of the source document: ____________________________

6. Note: _____________________________________________

7. Information on drugs:

№	Commodity code of GTIN (GTIN)	Description of goods	Dosage	Unit. -ism.	Dosage form	Code of identification of goods / packaging	Aggregate code	Expiration date	Number of batch/a series	Name of the company	The price for packaging
1	2	3	4		5	6	7	8	9	10	11

8. Information on results:

№ of payment order	Commodity code of GTIN (GTIN)	Number of consumer packagings	Name
1	2	3	4

Note:

* it is specified in case of input of data under the act of internal transfer of the Single distributor who is written out earlier on paper;

BIN – Business identification number;

GTIN – Global commodity identification number.

Appendix 10

to the Order of the Minister of Health of the Republic of Kazakhstan of June 19, 2024 No. 22

Appendix 15

to Rules of marking and traceability of medicines form

The notification on conclusion from turnover

General information

1. BIN, name, sender's address: _____________________

2. The conclusion reason from оборота*: ______________________________

Basis

3. Name документа*: ________________________________

4. Number документа*: _______________________________________

5. Date документа*: ________________________________________

6. Note: ____________________________________________

7. Information on drugs:

№	Code of identification of goods / packaging
1	2

8. Information on results:

№ of payment order	Commodity code of GTIN (GTIN)	Number of consumer packagings	Name
1	2	3	4

Note:

BIN – Business identification number;

GTIN – Global commodity identification number.

Appendix 11

to the Order of the Minister of Health of the Republic of Kazakhstan of June 19, 2024 No. 22

Appendix 16

to Rules of marking and traceability of medicines form

The notification on repeated input in turnover

General information

1. BIN, name, sender's address: _____________________

2. The input reason in оборот*: _________________________________

Basis

3. Name документа*: ________________________________

4. Number документа*: _______________________________________

5. Date документа*: ________________________________________

6. Note: ____________________________________________

7. Information on drugs:

№	Code of identification of goods / packaging
1	2

8. Information on results:

№ of payment order	Commodity code of GTIN (GTIN)	Number of consumer packagings	Name
1	2	3	4

Note:

BIN – Business identification number;

GTIN – Global commodity identification number.

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