Labeling of Pharmaceuticals in EAEU States

With the decision of the Council of the Eurasian Economic Commission (EEC) dated September 27, 2023, No. 108, the EAC marking regulation for pharmaceuticals and medicines has been approved through identification means.

EAC Marking of Pharmaceuticals and Medicines

According to the EAEU document, the member states of the Eurasian Economic Union (EAEU) independently establish the list of pharmaceuticals that are subject to EAC marking through identification means, the date of introduction, and the procedures for EAC marking on their territory in accordance with this decision. They inform the Eurasian Economic Commission at least 6 months prior to the introduction date of the EAC marking.

The following products are subject to EAC marking:

1. Pharmaceuticals, including those listed in the list of goods that must be marked according to this decision: registered in accordance with the provisions for EAC approval and EAC testing of pharmaceuticals for medical use, approved by the decision of the Council of the Eurasian Economic Commission dated November 3, 2016, No. 78, or in accordance with the laws of the EAEU member states.

2. Pharmaceuticals that are not subject to state EAC approval or unregistered pharmaceuticals, provided that the EAC marking of such pharmaceuticals is stipulated by the laws of the EAEU member states.

The EAC marking of pharmaceuticals manufactured in the EAEU territory is carried out by the manufacturer. In the case of importation into the EAEU customs territory, the EAC marking is carried out by the holder or owner, or another participant in the goods traffic specified by the law of the member state, by applying identification means according to the characteristics or carrier materials specified in this decision on the secondary packaging or on the primary packaging.

Marking of Pharmaceuticals in EAEU States 

For certain pharmaceuticals, the laws of the EAEU member states may establish specific requirements for the application of identification means or carrier materials containing identification means. In this regard, the EAEU member states inform the Commission about such pharmaceuticals and the mentioned specifics before the entry into force of the legal act that establishes these specifics.

With the EEC decision No. 108, the following were approved:

1. The list of goods that are subject to EAC marking through identification means.

2. The characteristics of the identification means for pharmaceuticals, requirements for the content and structure of the information contained in the identification means for pharmaceuticals, and the procedure for the production and application of such identification means.

3. Requirements for the format, content, and structure of information about marked pharmaceuticals that are transmitted between the competent EAEU authorities and the competent authorities of the EAEU Commission, as well as the deadlines for the transmission of such information and documents. 

4. The minimum information content about marked pharmaceuticals that is included in the information system for EAC marking of goods, which consumers and other interested parties can access, including through information services within the national components and the integrative component of the information system for EAC marking of medical products and medicines.

The document states that the Republic of Armenia does not intend to introduce EAC marking of pharmaceuticals at the time of the decision's entry into force. The decision comes into effect 30 calendar days after the official publication date.