Darnytsia Becomes the First in Ukraine to Transition to Electronic Submission of Registration Dossiers — Already Saving Thousands of Pages, Hundreds of Kilowatts, and Dozens of Trees

Darnytsia, a pharmaceutical company, became the first Ukrainian pharmaceutical manufacturer to fully transition to electronic submission of registration dossiers in the eCTD format as early as October 2024. This strategic step has not only optimized regulatory processes but is already yielding measurable environmental benefits.

In just six months of operating in electronic format, Darnytsia submitted six dossiers, including for initial registration, re-registration, and variation procedures.

By eliminating paper copies, the company saved 28,922 pages of documentation. This translates into the preservation of approximately 1.5 trees, around 3,400 liters of water, more than 1,300 kWh of electricity, and the prevention of nearly 195 kg of CO₂ emissions — equivalent to driving a car for 1,000 kilometers.

"We at Darnytsia are proud to be the first in Ukraine to switch to electronic dossier submission. This is not just a technological innovation — it is our conscious contribution to sustainability and environmental care. We don't wait for change — we lead it," says Kateryna Turlina, Head of the Ukrainian Registration Department at Darnytsia.

Within six months of digital operations, Darnytsia submitted six dossiers: three medicinal products for initial state registration (ampoules, tablets, infusions), one product in two dosages for re-registration, and two dossiers under the variation procedure. All submitted changes passed specialized expert evaluation and have already been approved.

It is worth noting that in Ukraine, the transition to electronic submission of registration materials is currently voluntary. However, starting August 18, 2025, this format will become mandatory for all applicants.