Tuesday, April 16, 2024

Medicines for Europe prepares for Ukraine’s forthcoming membership in the European Union (EU).

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Medicines for Europe held a meeting in Brussels with a high-level Ukrainian government delegation, led by Maryna Slobodnichenko, Deputy Minister of Health for European Integration. During the meeting, Medicines for Europe proposed strategies for planning the integration process, which involves aligning regulatory and market policies. These strategies include:

  1. Supporting the establishment of a dynamic medicines agency in Ukraine with assistance and expertise from leading agencies in EU Member States. This agency should aim to align with EU regulatory standards and marketing authorization requirements.
  2. Drawing insights from the experiences of other EU partners regarding the recognition of Good Manufacturing Practice (GMP), a prerequisite for medicine supply.
  3. Accelerating the alignment of digital regulatory requirements, including electronic Product Information (EPI), electronic Common Technical Document (eCTD), and access to the EudraGMDP* database. These digital tools are essential for modern medicine regulation.
  4. Ensuring Ukraine’s swift integration into EU safety systems, such as the European Medicines Verification System (EMVS), to combat counterfeit medicines.

Medicines for Europe expressed its commitment to collaborating with the EBA** of Ukraine to expedite regulatory alignment and integration in the field of medicines. This support aims to facilitate Ukraine’s rapid and effective accession to the EU.

Adrian van den Hoven, Director General of Medicines for Europe, emphasized the need to transition to the next phase of their relationship. While addressing medicine shortages in Ukraine remains a priority, focusing on pharmaceutical regulation is essential for Ukraine’s accession process. The goal is to initiate a progressive integration into EU data and regulatory systems, ultimately enhancing patient access to medicines in alignment with EU safety, quality, and efficacy standards.

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