The composition of information included in the marking code, the procedure for forming and applying digital identification means on the consumer packaging of medicines and medical devices is regulated by the Resolution of the Cabinet of Ministers of the Republic of Uzbekistan dated 02.04.2022 No. 149.
According to Clause 8 of this Resolution, "Digital marking of medicines and medical devices is carried out by forming and applying to the consumer packaging a digital identification means (machine-readable marking code) in the form of a two-dimensional barcode in the form of a GSI Data Matrix."
What the marking code of a medicinal product must contain
The marking code, created by the Operator, contains information distributed across 4 groups, of which the first and second groups form the identification code of the consumer packaging, and the third and fourth groups form the verification code; at the same time, the GSI Data Matrix symbol must contain the code symbol 232 in the ASCII character table;
the first data group - product code consisting of 14 characters (digits), preceded by the application identifier (01), developed by the Operator during the registration of the medicine or medical device in the product catalog based on the provided information;
the second data group - individual serial number of the trade unit, representing the previous identifier (21) and consisting of 13 numeric characters or an alphanumeric sequence (in the Latin alphabet). For this group, a special separator character should be used as the end mark, which in the ASCII character table contains the symbol with code 29 or 232;
the third data group - a 4-character (digits, lowercase and uppercase Latin letters, as well as special symbols) verification key identifier (individual serial number) identified by application code (91) and created by the Operator. This group must have an end mark, a special separator with code 29 or 232 in the ASCII character table;
the fourth data group - identified by a verification code of 44 characters (digits, lowercase and uppercase Latin letters, as well as special symbols) and application code (92) and created by the Operator.
The data groups must be arranged sequentially, from the first to the fourth.
As a result, the marking code, which contains all the necessary information about the medicinal product in the correct order, should look as follows:
In printed text form, this code looks as follows:
010432345678817621AF9-&eDmMbl?6CkOyAEB91UZF092TDRFasF7Lf27Qv4/muaq3qoqmZ5x3WAKhKoLmzlyNi4=
The code includes:
(01) 04780101164394 - GTIN of the product (Global Trade Item Number) 14 characters long;
(21) ХzmjQbgliy5Xd - SN (Serial Number) 13 characters long;
(91) UZF0 - verification key 4 characters long;
(92) VVFVeDFM9cVd5zuu8avME8HQne9gxKQ8OH5ccczHLAg= - verification code 44 characters long.
At the same time, the verification key with the verification code is also collectively called the crypto-tail (CT).
Example of direct application on secondary consumer packaging
According to Clause 11 of the Resolution, "The product code and individual serial number of the consumer packaging are indicated at the discretion of the manufacturer in the form of human-readable printed text," as shown in the image:
The digital marking Operator sets requirements only for the digital identification means (Data Matrix code); other requirements regarding human-readable information must be complied with according to PCM No. 365 dated 27.10.2016 "On approval of the general technical regulations on the safety of medicines."
Requirements for the applied marking code
The digital identification means applied on the consumer packaging must meet the following requirements:
the marking code is applied to the consumer packaging by printing or by means of a sticker during the shelf life of the medicine and medical device in such a way that the marking code cannot be separated from the consumer packaging without damage;
the marking code is applied to the consumer packaging in a specially designated contrasting area (size at least 10x10 millimeters) or by sticking a sticker;
the marking code can be applied on the production line, at the territory of a subordinate warehouse, on secondary (consumer) packaging of the medicinal product (if absent) at enterprises or warehouses having the appropriate license for pharmaceutical activity and/or production of medicines, in the country of their location, authorized by the owner of the medicine registration certificate, on primary packaging of the medicinal product) with application of a two-dimensional barcode on a physical carrier (label);
It is allowed to apply digital marking of medicines and medical devices that have not undergone marking with digital identification means on the territory of a customs warehouse under the customs regime "release for free circulation (import)";
the size and location of the digital identification means must ensure the possibility of direct detection and reading of the marking code without the need to open (damage) the consumer packaging;
digital identification means must not be printed on transparent packaging film or other external packaging material and covered by other information;
digital identification means must be placed on the consumer packaging in accordance with the legislation of the Republic of Uzbekistan and regulatory documents in the field of technical regulation in such a way that the integrity of printed information is not violated;
The digital identification means is used according to ISO/IEC 15415 standard at quality class C level or higher;
If there is secondary (external) packaging of medicines and medical devices, only the secondary (external) packaging has digital marking;
If there is no secondary (external) packaging of medicines and medical devices, the primary (internal) packaging must have digital marking.
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