Pharmaceutical companies have to make changes to medicines registration files
The Ministry of Economic Development of Ukraine reported that goods put in circulation in Ukraine from January 1st, 2019 must comply with the International System of Units SI, which means that units on label should be written in Latin or Greek alphabet letters. There are no exceptions provided for medicines.
The corresponding peremptory rule is set by Order of the Ministry of Economic Development of Ukraine “On Approval of Definitions of Main SI Units, Names and Definitions of Derivative SI Units, Decimal Multiples and Fractionals from SI Units, Allowed Non-System Units, as well as Their Designations and Rules for Applying Units of Measurement and Writing Names and Designations of Units of Measurement and Symbols of Quantities” No. 914 as of August 4th, 2015.
From the set date package labels can bear designations of measurement units in Ukrainian also (with the use of Ukrainian alphabet).
The Ministry reasoned its firm position by the necessity to harmonize legislation of Ukraine with the EU legislation within the Eurointegration process, in particular, Council Directive 80/181/EEC as of December 20th, 1979, where there is no exception for pharmaceutical products.
It should be noted that recently Order of the Ministry of Economic Development of Ukraine No. 914 did not relate to medicines, since legislation directly set that marking of medicines, instructions for use, etc. must be in the state language. However, the Law of Ukraine “On Fundamental Principles of State Language Policy” was declared unconstitutional and invalidated on February 28th, 2018.
On August 22nd, 2018 the Ministry of Health of Ukraine, as a specialized ministry, applied to the Ministry of Economic Development of Ukraine with an offer to remove medicines from regulation of Order of the Ministry of Economic Development of Ukraine No. 914. However, for today the Ministry of Economic Development of Ukraine has not accepted this position yet.
If the situation does not change in the near future pursuant to Order No. 914, putting medicines in circulation starting from January 1st, 2019 will require changes to registration case file of medicines as concerns language of measurement units marking. Accordingly, this requires time.
Contact the author: junior associate Julia Vyhkrovskaya, firstname.lastname@example.org.