In connection with the need to eliminate the conflict in the requirements for indicating the units of measurement on the labeling of medicinal products (MERT Order No. 914), the Association appealed to the Ministry of Health of Ukraine and received an official response.

We would like to remind you that in accordance with the order of the Ministry of Economic Development and Trade of Ukraine No. 914 dated 04.08.2015 “On approval of definitions of basic SI units, names and definitions of derived SI units, decimal multiples and fractions of SI units, permitted non-systemic units, as well as their designations and According to the rules for the use of units of measurement and the writing of names and designations of units of measurement and symbols of quantities” (hereinafter – “Order No. 914”) and further received official clarifications, the units of measurement on the labeling of medicinal products from 01.01.2019 must be indicated using Latin or Greek letters alphabet (eg “ml”, “kg”). That is, from 01.01.2019, products cannot be put into circulation in Ukraine, in the labeling of which only Ukrainian designations of measurement units are used (for example, “ml”, “kg”), as is currently happening in the field of medicinal products and is required by law in all current legislation base, which regulates the circulation of medicinal products.

According to the experts of the Association, non-alignment of the sectoral regulation in the field of circulation of medicines with Order No. 914 from 01.01.2019 may lead to another collapse in the pharmaceutical market, namely:

• in the impossibility (and impracticality) of registration and re-registration of medicinal products – since the labeling of such medicinal products will no longer meet the requirements of Order No. 914;
• uncertainty regarding medicinal products that are in circulation and comply with industry legislation in the field of medicinal products (due to the lack of a detailed explanation of the term “introduction into circulation” in relation to medicinal products);
• threats of prohibition by the State Production and Consumer Service of medicinal products, the labeling of which will not meet the requirements of Order No. 914 and the imposition of sanctions on subjects of the pharmaceutical market;
• the threat of restricting the access of Ukrainian citizens to the treatment they need.

Based on the results of consideration of the appeal, the Association of the Ministry of Health of Ukraine appealed to the Ministry of Health of Ukraine and the State Production and Consumer Service regarding the following:

“Considering that the mentioned Order of the Ministry of Health of Ukraine No. 914 was not approved by the Ministry of Health of Ukraine, with the aim of harmonizing the provisions of industry regulation in the field of health care and the field of metrology and metrological supervision, avoiding duplication of functions by supervisory bodies in the specified areas and, above all in order to avoid the threat of unjustified restriction of access of citizens of Ukraine to the treatment they need, which may arise as a result of large-scale changes in the labeling of medicinal products in terms of changes in the writing of units of dosage measurement, which in turn will introduce misunderstandings in the interpretation for patients, etc., we consider it expedient to withdraw medicinal products from spheres of action of the Order of the Ministry of Internal Affairs and Communications No. 914 by making appropriate changes to Clause 2 of the Order of the Ministry of Internal Affairs and Communications No. 914.” 

The association hopes for a quick and constructive further reaction of the relevant authorized state bodies to the current situation and the settlement of the specified legal conflict in order to ensure timely access of the citizens of Ukraine to the medicines they need.