On November 10, 2023, the EEC Council Decision No. 108 of September 27, 2023 “On the Labeling of Medicinal Products with Identification Means” came into force. According to this decision, EAEU member states must independently determine the list of medicinal products subject to identification labeling, the date of introduction, and the procedure for labeling in their territory, and notify the EEC at least six months before the introduction of the labeling.

Main requirements summarized:

1.  The following medicinal products are subject to labeling:

• Those registered according to the Rules for Registration and Examination of Medicinal Products for Medical Use, approved by the Decision of the EEC Council dated November 3, 2016, No. 78, and/or according to the legislation of the member states.
• Medicinal products not subject to state registration or unregistered medicinal products if the labeling of such products is provided for by the legislation of the member states.

2.  Labeling of medicinal products produced in the Union is carried out by the manufacturer, and in the case of importation into the customs territory of the Union, by the holder or owner of the registration certificate by applying identification means.

For certain medicinal products, the legislation of the member states may establish specific requirements for the application of identification means or a material carrier containing the identification means. Member states must notify the Commission about such medicinal products and the specific requirements before the entry into force of the regulatory legal act establishing these requirements.

Labeling of remaining medicinal products is not carried out; such products are stored, transported, and sold until their expiration date.

Labeling does not apply to the following medicinal products:

• Veterinary
• Produced for clinical trials
• Not subject to state registration
• Intended for use in military actions, emergencies, prevention and treatment of diseases posing a danger to others, etc.
• Radiopharmaceuticals
• Medical leeches and gases.

Member states independently determine national operators to ensure the functioning of the information system for labeling goods.

Interaction in cross-border trade between a member state where labeling is introduced and a member state where labeling is not introduced is carried out in accordance with the legislation of the member state where labeling is introduced. 3. The legislation of the Kyrgyz Republic may define requirements for identification means different from those established by this Decision. In this case, medicinal products are not subject to circulation in the territories of member states that have introduced labeling of medicinal products in accordance with this Decision. The Kyrgyz Republic ensures the recognition of identification means that meet the requirements approved by this Decision and applied to medicinal products imported from the territories of member states.

3.  The Decision indicates that the Republic of Armenia has not confirmed its intention to introduce the labeling of medicinal products in accordance with these rules as of the effective date. However, this does not mean they will not approve the labeling rules for medicinal products according to this Decision in the future.

From the date of introduction of labeling in their territories by two or more member states, mutual recognition of identification means is ensured in cross-border trade provided that:

4.  The Decision also approves:

• The list of goods subject to identification labeling.
• Characteristics of identification means for medicinal products, requirements for the composition and structure of information contained in identification means, and the procedure for forming and applying such identification means.
• Requirements for the format, composition, and structure of information about labeled medicinal products transmitted between competent (authorized) bodies of member states and between competent (authorized) bodies of member states and the Commission, as well as the deadlines for transmitting such information.
• The minimum composition of information about a labeled medicinal product contained in the product labeling information system, access to which is provided to consumers and other interested parties, including through information services within the national components and the integration component of the product labeling information system.
• The Decision approves the characteristics of the identification means for medicinal products, the requirements for the composition and structure of information contained in the identification means, the procedure for generating and applying the identification means:
• A unique sequence of characters represented in a two-dimensional barcode format Data Matrix GS1, suitable for machine reading, and formed according to the requirements of the international standard ISO/IEC 16022:2006 “Information technology – Automatic identification and data capture techniques – Data Matrix bar code symbology specification” or an identical national standard of an EAEU member state is used for labeling medicinal products. The ECC 200 symbol with the use of the FNC1 sign as an indicator of data compliance with the typical format of GS1 application identifiers (AI) must be used when converting this unique sequence of characters into an identification means.

5.  The identification means include the following data:

• The first group is identified by the application identifier AI=’01’, consists of 14 digits, and contains the product code (Global Trade Item Number (GTIN)).
• The second group is identified by the application identifier AI=’21’, consists of 13 characters (digits, lowercase and uppercase Latin letters). This group contains the individual serial number of the product (package), with the first character indicating the member state identifier where this code was issued (1 – Republic of Armenia, 2 – Republic of Belarus, 3 – Republic of Kazakhstan, 4 – Kyrgyz Republic, 5 – Russian Federation), and this group ends with the ASCII 29 delimiter.
• The third group is identified by the application identifier AI=’91’, consists of 4 characters (digits, lowercase and uppercase Latin letters), and contains the identifier (individual serial number) of the check key formed by the national operator (administrator) as part of the check code. The ASCII 29 delimiter is used as the end for this group.
• The fourth group is identified by the application identifier AI=’92’, consists of 44 characters (digits, lowercase and uppercase Latin letters, and special characters), and contains the value of the check code formed by the national operator (administrator).

Identification means are formed by issuers of identification means in member states, manufacturers, holders, or owners of registration certificates, or participants in the circulation of goods determined by the legislation of member states.

Goods are labeled by applying the identification means or a material carrier containing the identification means to the secondary (consumer) packaging or primary packaging (if there is no secondary (consumer) packaging) in a way that does not allow the identification means and/or material carrier containing the identification means to be separated from the medicinal product packaging without damage.

When packaging labeled goods into transport (tertiary) packaging, the transport (tertiary) packaging may be labeled with a transport (tertiary) packaging identification means, which contains the identification code of this packaging, with aggregation of the identification means of the goods placed in the transport (tertiary) packaging. The participant in the circulation of goods carries out the aggregation of medicinal products with one Global Trade Item Number and one production batch number.

The formation of the identification means for transport (tertiary) packaging and labeling of transport (tertiary) packaging is carried out in accordance with GS1 international standards. The identification code of the transport (tertiary) packaging of the medicinal product represents a unique identifier of the transport packaging in the form of a Serial Shipping Container Code.

6. The Decision approves the minimum composition of information about a labeled medicinal product contained in the product labeling information system:

• Global Trade Item Number (GTIN).
• Individual serial number of the product unit (SN).
• Product name.
• International nonproprietary or chemical, or group name of the medicinal product.
• Information about the product: production batch number; expiration date; dosage form; dosage (concentration); quantity of dosage forms in the package, unit of measurement of quantity; registration certificate (for registered medicinal products – certificate number, registration date); type of packaging.
• Information about the business entity that provided information about the labeled product.
• Available information about the participants in the production of the medicinal product.
• Information about the status of the medicinal product.

Cratia professionally performs registration of medicinal products and pharmacovigilance in the EAEU. We have deep knowledge in national legislation, necessary experience and resources. To start cooperation or get a consultation, you can contact us at +380680647831, +442081239125, or via email: info@cratia.ua.