Significant changes have been made in the regulatory landscape governing medicinal products in Armenia. Effective April 25, 2024, the Armenian Health Authority responsible for the registration processes has renamed the responsible center from the “Scientific Center of Drug and Medical Technology Expertise after academician E. Gabrielyan” to the “Center of Drug and Medical Technology Expertise”. In addition to this name change, the type of organization has also changed from a Closed Joint Stock Company (CJSC) to a State Non-Profit Organization (SNPO).
Changes to payment procedure and its impact on applicants
This change to an SNPO results in a more complicated payment procedure, as payments are now directed to the State Treasury Division, and proforma invoices are no longer issued. This causes difficulties for applicants in documenting their payments and requires additional input from local representatives to resolve the issue through negotiations with the Finance Department of the Agency. Furthermore, fees for some services have increased, necessitating local representative consultancy for cost-efficient planning of submissions.
How can you approach these changes with peace of mind?
ClinChoice’s highly qualified Regulatory Affairs team including those in our Armenia Delivery Center, are here to help you navigate these changes and to help you manage end-to-end registration processes for medicinal products in Armenia and beyond, ensuring smooth market entry and compliance for pharmaceutical products in the evolving EAEU regulatory environment. Talk with a specialist today to learn how ClinChoice can help you navigate the regulatory landscape.
About the Author
Yekaterina Perikhanyan has a strong background in life sciences, specializing in Chemistry, and brings over six years of experience working in environmental and pharmaceutical laboratories. For the past four years, she has been a dedicated member of the Regulatory Affairs Department at ClinChoice, focusing on the registration processes for medicinal products and medical devices across the EAEU, European, Middle Eastern, and African markets. Recently, Yekaterina has pursued her interest in project management and has earned valuable certifications in this field, including PMP and PMI-ACP from the Project Management Institute.
About ClinChoice
ClinChoice is a global full- and functional service CRO providing exceptional product development and lifecycle management capabilities for pharmaceutical, biotechnology, medical device, and consumer health companies. We have three decades of proven expert service delivery and noteworthy results across all our services. With a strong presence in more than 20 countries across the Americas, Europe, and Asia-Pacific, we are strategically positioned to fulfil our clients’ business requirements locally and globally. We offer high-quality, full-service clinical development and post-marketing solutions. For our clients, it means a reliable partner and quality results.