IMPROVE MEDICAL sponsored the General Meeting of members of the Association of the Medical Devices Market Operators for the second half of 2018 that took place on November 9, 2018 at the RAMADA KIEV ENCORE hotel.
IMPROVE MEDICAL is the member of the Association “Medical Products Market Operators” since 2016 and actively participates in its sessions and meetings.
The event was attended by Myroslava Boichuk and Svetlana Zgonnyk and Elena Hoi, auditors.
First of all, the speaker divided the statutory instruments regulating medical products marking on the existing ones:
- Law of Ukraine “On Protection of Consumers’ Rights”;
- Law of Ukraine “On the general safety of non-food products”;
- “Subject” technical regulations in respect of medical products (No.s 753, 754, 755, approved by the Cabinet of Ministers of Ukraine on Oct. 02, 2013);
and new and planned:
- Order No. 914 of the Ministry of Economic Development of Ukraine of August 04, 2015 “On the approval of definitions of basic SI units, names and definitions of SI derived units, decimal multiples and quotients of SI units, allowed miscellaneous units, as well as their designations and Rules of the application of measurement units and spelling of names and designations of measurement units and quantity values”;
- Bill “On ensuring functioning of the Ukrainian language as official” (Reg. No. 5670-д), adopted on October 4, 2018 in the first reading.
M. Boichuk recalled that in February 2018, the Law of Ukraine “On Principles of the State Language Policy” was declared unconstitutional. Therefore, for its substitution, the Law “On Ensuring the Ukrainian Language Performance as the State Language” should be adopted (hereinafter — Law) to regulate functioning and application of the Ukrainian language as the state language in all spheres of public life on the whole territory of Ukraine. According to the Law, producers (performers, sellers) in Ukraine of any form of ownership provide consumers with information about goods and services in the state language.
The Law establishes requirements for specifying geographical names. The names of geographic objects located on the territory of other states, as well as geographic objects that are not subject to the sovereignty and jurisdiction of any state are intended for use in the official language in the transcription from the source language by reference to specific features of the Ukrainian phonetics and spelling. “What does it mean? You have to transliterate both the address and the name of the manufacturer” — commented M. Boichuk. At the same time, she recalled that today there is only an approved table of transliteration of the Ukrainian language to the Latin alphabet, but there is not a converse one. Therefore, the Law projects creation of the National Commission on State Language Standards. It should approve standards for transcription and transliteration. For the future, economic agents should use these rules to transliterate names and addresses of manufacturers.
The Law will also amend the Law of Ukraine “On Protection of Consumers’ Rights” and definition of the term “marking”. According to the new definition, marking is the application of text, specific symbols, reference characters and drawings on the packaging and / or products. The carrier of a product marking may be the product itself, its component parts, stickers or labels on the product.
One of the most important clauses of the future Law, in the judgment of the speaker, is the following: if, in addition to information in the state language, marking, user guide, and information about goods and services, contain text in other languages, then the content and volume of marking, user guide, information about goods and services in the state language cannot be less than filling in any other language.
As for brand and technical documentation language, M. Boichuk stated that signs for goods and services are given in the form in which they are provided legal protection in Ukraine subject to the Law. If a trademark is not registered on the territory of Ukraine, it should be transliterated. Technical and project documentation in Ukraine should be made in the state language.
Speaking about Order No. 914 of the Ministry of Economic Development, the speaker recalled that its scope covers both medicines and medical products. According to the provisions of the document, on the marking of products provided on the Ukrainian market, the international designation of measurement units are applied (using letters of the Latin or Greek alphabet). At the same time, Ukrainian symbols for measurement units (using letters of the Ukrainian alphabet) may be applied for marking. Relevant requirements should become statutory for market operators from January 1, 2019. However, on October 29, 2018, the Ministry of Economic Development published a draft Order “On Amendments to Order No. 914 of the Ministry of Economic Development and Trade of Ukraine of August 4, 2015” on extension of the transitional period until January 1, 2021.
According to M. Boichuk, the extension of the transition period will allow manufacturers to bring the marking into compliance with the requirements of Order No. 914.
Photo – Editorial Office apteka.ua