An online meeting with representatives of the pharmaceutical market was held at the State Expert Center, dedicated to the issues of parallel import of medicinal products, its legal regulation and practical aspects of application.
More than 100 participants joined the professional dialogue – manufacturers, importers, distributors, representatives of relevant business associations and regulatory specialists.
The event was attended by the management and experts of the State Expert Center, representatives of the State Service of Ukraine on Medicines and Drugs Control, as well as colleagues from the Republic of Lithuania, who are currently assisting Ukraine within the framework of the international Twinning project.
The early entry into force of Article 78 of the Law of Ukraine "On Medicinal Products" regarding parallel import is of strategic importance for the national healthcare system. In the conditions of a full-scale war, this instrument is intended to contribute to increasing the availability of medicinal products for the population, creating conditions for reducing prices for medicines through new supply channels and bringing market instruments closer to EU practices. It is expected that over time the share of parallel import in Ukraine may reach the levels of countries such as Sweden or the Netherlands, where it stands at about 25%.
During the meeting, the participants reviewed the general principles of legal regulation of parallel import, procedural issues of dossier review and criteria for compliance of imported medicines, requirements for packaging labelling, the organisation of the pharmacovigilance system and specific features of auditing importers.
Invited experts from Lithuania – Head of the State Medicines Control Agency Dovilė Marcinkė and Adviser of the Pharmaceutical Policy Department of the Ministry of Health Kristina Povilaitienė – shared practical cases of implementing parallel import in EU countries. They spoke about the interaction between the participants in the process and how parallel import helps to avoid shortages of critically important medicines.
The key point emphasised was that simplifying the procedure for importing medicines does not mean weakening control over their quality and safety. Parallel import in Ukraine will function exclusively on the basis of absolute transparency and strict adherence to regulatory procedures. Protecting the health and safety of Ukrainian patients remains the highest priority at every stage of the circulation of medicinal products.
Despite the air raid alert announced during the event, the professional dialogue did not stop and continued in full in the shelter.
We thank business representatives, as well as all involved parties and international partners, for the constructive dialogue. The Center will continue to hold similar consultations for the market in order to ensure a smooth and effective launch of the tool.
