❓ Are there any requirements for stickers when labeling medicinal products?

Самира Мухамедова

Labeling of medicinal products and medical devices is regulated by the Cabinet of Ministers Resolution No. 149 dated 02.04.2022. The requirements for stickers are specified in this regulatory legal act.

The following requirements apply to stickers applied to consumer packaging:

✔️The sticker must be applied directly on the production line, or at the premises of a subordinate warehouse, or warehouses that have the appropriate license for pharmaceutical activities and/or production of medicinal products in the country of their location;
✔️the sticker must be manufactured in such a way as to ensure the storage and reading of the digital identification means and other information printed on it from the moment of its manufacture until its sale to the end consumer;
✔️the sticker must contain a digital identification means that meets the requirements of this Regulation, as well as the name of the medicinal product with digital labeling in the form of readable printed text, the product code, and the individual serial number of the package;
✔️it is not allowed to apply any inscriptions, drawings, or packaging elements on the sticker that cover the surface of the sticker and/or prevent reading of the digital identification means;
✔️the sticker is applied directly to the packaging (the outer side of the packaging) at the place provided by the structural scheme of such packaging for its application;
the sticker is applied to the packaging only in a way that does not allow separating the packaging and the sticker itself without damage, and also in such a way that they cannot be reused;
✔️applying the sticker must not violate the integrity and availability of the information applied to the packaging, in accordance with the requirements of regulatory documents in the field of technical regulation.