Labeling requirements: Self-destructive labeling code (sticker application) - Medicinal products

Labeling of medicinal products and medical devices is regulated by Resolution of the Cabinet of Ministers No. 149 of 02.04.2022.

According to paragraph 8 of this Decree, digital labeling of the product group "Medicines" is carried out by forming and applying digital identification means (machine-readable type labeling code) as a two-dimensional barcode in the form of GSl Data Matrix on the consumer package. In this case, the labeling code must be applied in such a way that it could not be damaged during packaging of goods and subsequent transportation.

Can a code be put on a sticker?

It is allowed to apply a digital identification means to the material carrier (sticker) in the following cases:

• the material carrier (sticker), containing the means of digital identification, shall be applied to the consumer package in such a way that the means of digital identification cannot be separated from the package without damage;
• the means of digital identification applied to the material carrier (sticker) must comply with the requirements of this Regulation.

Rules for applying the labeling code to the consumer packaging

The following requirements apply to the stickers applied to the consumer packaging:

• the sticker must be applied directly on the production line, or on the premises of a subordinate warehouse, or warehouses having the appropriate license for pharmaceutical activities and/or production of medicines, in the country of their location;
• the sticker is made in such a way as to ensure the storage and reading of the digital identity product and other information printed on it, from the time of its manufacture until it is sold to the final consumer;
• the sticker is applied directly to the package (exterior side of the package) in the location provided by the design scheme of such packaging for its application;
• the sticker is applied to the package only in such a way that it is impossible to separate the package and the sticker itself without damaging it, and also in such a way that they cannot be reused;
• application of the sticker must not compromise the integrity and accessibility of information on the package in accordance with the requirements of regulatory documents in the field of technical regulation;
• the sticker must contain a means of digital identification that meets the requirements of these Regulations, as well as the name of the medicinal product with a digital labeling in the form of legible printed text, the product code and the individual serial number of the package;
• no inscriptions, drawings or packaging elements covering the surface of the sticker and (or) preventing the reading of the digital identification means shall be applied to the sticker.

Are goods that were labeled before the introduction of mandatory labeling considered labeled?

Medicinal products and medical devices with digital labeling prior to the date of mandatory digital labeling are recognized as labeled if the information on labeling has been sent to NIS "ASL Belgisi".

For the composition of the information included in the labelling code and the procedure for forming the labeling code for medicinal products and medical devices, read the article "Medicinal product labeling code: what it contains and how it looks like".