Introduction of mandatory marking using the units of the International System of Units (SI)

From January 1, 2019, the symbols for use in the labeling of all products put into circulation in the territory of Ukraine, should be indicated in accordance with the Regulations, approved by the Order of the Ministry of Economic Development and Trade No. 914. Specifically, units of measurement should be indicated using those of the International System of Units(SI), for example:

• мг – mg,
• мл – ml,
• Гц – Hz.

The effect of the Order No. 914 applies to all types of medical products containing the units of measurement on the labeling, including following:

• medicines;
• medical products;
• cosmetic products and dietary supplements, including foods for special medical purposes, as well as foods for weight control.

Medicines are at the worst situation, since making changes to the package labeling requires submission of the Application, payment of expert work, conducting appropriate examination, obtaining a positive decision, signing the order, and then adding the updated layouts to the Unified Automated Information System (UAIS) of the State Drugs and Medications Control Service.

However, it remains unclear how to indicate the composition in both registration certificate, instructions and quality control methods. Is it necessary to indicate that the labeling language is not only Ukrainian, but also Latin (Greek)? There are a lot of other failures in legislative acts.

According to our information, no drug manufacturer has brought the labeling into the line with the requirements of Order No. 914.

On October 29, 2018, the Ministry of Economic Development and Trade of Ukraine (hereinafter – MEDT) published a Draft Order on its website “On Amendments to the Order of the MEDT of Ukraine No. 914 dated August 4, 2015” (as an attachment). A Draft Order foresee the prolongation of transition period to January 1, 2021 (Proposed Draft Order prolongs transitional period (for 2 years)) for labeling of all products.

The link: https://bit.ly/2CPsiIy

We assume that these amendments will be made before the end of this year or in the first days of the upcoming.

P.S.: for all manufacturers of medical devices; dietary supplements, including foods for special medical purposes, as well as foods for weight control; cosmetic products, we strongly recommend bringing the label into the line. Since changes to the labeling do not pass the seven circles of expertise, but are exclusively within the area of responsibility of the manufacturer, there may be no indulgences, as for medicines.