Decision of the EEC Council No. 108 dated September 27, 2023 approved the procedure for labeling of medicines with means of identification. This write the publication “Pharmaceutical Review of Kazakhstan”.
Labeling is subject to:
– medicinal products, including those specified in the list of goods subject to marking with means of identification approved by this Decision:
- registered in accordance with the Rules of registration and examination of medicinal products for medical use, approved by Decision of the Council of the Eurasian Economic Commission dated November 3, 2016 № 78 and (or) in accordance with the legislation of the member states;
- not subject to state registration or unregistered medicinal products, in case the labeling of such medicinal products is provided for by the legislation of the Member States.
Labeling of medicinal products manufactured on the territory of the Union shall be carried out by the manufacturer of such medicinal products, and in case of importation into the customs territory of the Union – by the holder or owner of the registration certificate of the medicinal product or other participant in the turnover of goods, determined by the legislation of the Member State, by applying means of identification corresponding to the characteristics approved by this Decision, or material carriers containing such means of identification, to the secondary (p p
For certain medicinal products, the legislation of Member States may establish peculiarities for the application of the means of identification or the material carrier containing the means of identification. The Member States shall inform the Commission about such medicinal products and the abovementioned peculiarities before the entry into force of the normative legal act establishing these peculiarities.
By resolution approved:
– list of goods subject to marking with means of identification;
– characteristics of the means of identification of medicinal products, requirements to the composition and structure of information contained in the means of identification of medicinal products, procedure for generation and application of such means of identification;
– requirements to the format, composition and structure of information on labeled medicinal products transferred between the competent (authorized) authorities of the Member States and between the competent (authorized) authorities of the Member States and the Commission, as well as the terms of transfer of such information;
– minimum composition of information on a labeled medicinal product contained in the information system for product labeling, access to which is provided to consumers and other interested parties, including through information services as part of national components and the integration component of the information system for product labeling.
The document provides information that the Republic of Armenia as of the date of entry into force of the decision has no intention to introduce labeling of medicines.
The decision enters into force upon expiration of 30 calendar days from the date of its official publication. To view the text of the document, please here.
