Darnytsia is Сonfidently Moving Towards a Complete Transition to the Submission of Registration Dossiers in Electronic Format
Darnytsia Pharmaceutical Company is confidently implementing digital solutions in the field of regulatory support for medicinal products. As a company that supports the national course towards the digitalization of healthcare, Darnytsia became the first domestic manufacturer to officially announce its participation in the pilot period of electronic submission of registration dossiers.
Today, the company is actively moving towards a full transition to the submission of registration dossiers in electronic format.
The first step in this direction was made on October 15, 2024, when the company submitted its first dossier in eCTD format. The successful completion of all stages of such submission became a catalyst for scaling up—the regulatory team of Darnytsia decided to cover all types of registration procedures: initial registration, re-registration, and making changes.
Within six months, the company submitted in electronic format:
• 3 medicinal products for state registration (ampoules, tablets, infusions);
• 1 medicinal product in two dosages for re-registration;
• 2 medicinal products for the procedure of making changes.
All submitted changes to the dossier materials successfully passed specialized expertise and received a recommendation for approval.
"We are convinced that digitalization is not only a requirement of the times, but also a powerful tool for increasing transparency, accuracy, and quality control at every stage of interaction with regulatory authorities. The experience of Darnytsia proves that the electronic format of dossier submission is effective, convenient, and safe for all market participants. We urge our colleagues in the industry to actively join the digital transformation," notes Kateryna Turlina, Head of the Ukrainian Registration Department at Darnytsia Pharmaceutical Company.
Let us remind you that Ukraine is in the process of transitioning to the electronic format for submitting registration dossier materials for state registration, re-registration, and making changes to registration documents for medicinal products. Currently, this process is voluntary, but from August 18, 2025, it will become mandatory for all applicants.