Advocacy successes of the week

20/ 11/ 2020

Despite some slowdown in business activities amid the second wave of the pandemic, this week has been quite successful for the EBA community regarding the protection of business interests. Together, we have fostered effective decision-making that establishes more transparent regulatory conditions for the smooth operation of companies in the areas of healthcare, logistics, and consumer electronics.

1. Clarifications on the use of SI labeling for medicines are received

European Business Association is pleased to inform about the official publication of the MOH clarification letter of November 17, 2020, regarding the application of the provisions of Order No. 914 of the Mineconomy, concerning SI labeling of medicines, coming into force on January 1, 2021.

As is commonly known, the apparent inconsistencies of Order No. 914 of the Mineconomy with the provisions of industrial standard regulations in the field of drug circulation put under threat the timely and sustainable supply of high quality and safe medicines to Ukraine.

MOH clarification letter defines the procedure for manufacturers and importers of medicines who will import medicines into Ukraine after January 1, 2021. The clarification letter contains the explanation of the rules for market entities on medicines manufactured before the new requirements came into force and also details the correlation of the provisions of Order No. 914 of the Mineconomy with the current legislation in the field of drug circulation.

2. The State Regulatory Service did not approve the draft order of the Mintrans on the procedure for decommissioning freight cars

The European Business Association welcomes the decision of the State Regulatory Service to disapprove the draft Order of the Ministry of Infrastructure of Ukraine on the procedure for establishing a ban on the operation of freight cars. This decision was insisted on by the EBA member companies.

It will be recalled that on October 12, 2020, the Ministry of Infrastructure published a draft Order, which proposed to approve the procedure for establishing a ban on the operation of freight cars. According to the calculations of the EBA Logistics Committee, most of the car fleet of companies, namely gondola cars could be decommissioned by 2028 under the draft Order in question. Thus, experts believe that it is necessary to focus on the maximum life cycle of cars with the possible continuation of their operation considering the technical condition given the world practice. Therefore, companies opposed the introduction of restrictions on the service life of freight cars, as it could also lead to an acute shortage of cars and rising prices.

3. EBA welcomes the continued harmonization of technical regulations with EU requirements

The EBA welcomes the adoption of the Governmental Resolution No. 1097 from 11 November 2020, which introduced the amendments proposed by the EBA to certain technical regulations on energy labeling of air conditioners, as well as eco-design requirements for circulating pumps and TVs.

Experts of the EBA Consumer Electronics Committee actively cooperated with government agencies to promptly adopt the changes proposed by the business to avoid certain discrepancies in the texts of technical regulations on requirements for air conditioners, TVs, and pumps with the texts of the relevant EU Directives, based on which Ukrainian regulations were developed. Thus, the ecodesign requirements for equipment in Ukraine were stricter than similar requirements that were introduced in the EU. As for the TRs for air conditioners, there were differences between the colors used on the label to depict the map of Ukraine and the requirements for the colors of the map given in the text of the technical regulations. Therefore, the business called for the harmonization of technical regulation in Ukraine in accordance with EU requirements to be able to effectively fulfill its obligations to the state and consumers.

Therefore, the EBA sincerely thanks the authorities for considering our expert proposals and hopes for further constructive cooperation that will bring the business community even better news in the coming weeks!


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