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At the end of November, the Authorities in Armenia released the Government Decree #1715 on the Implementation of a Pilot Project for Marking of Medicine.
Pilot Project Overview
The scope of the Pilot project covers pharmaceutical products and vaccines. The starting date of the project is 31 October 2024.
The authorized body for the implementation of the program is the State Revenue Committee of the Republic of Armenia. The program and the evaluation of its results are carried out under the supervision of the State Revenue Committee of the Republic of Armenia and the “Center for the Development of Technologies – Armenia”. The Office of the Prime Minister of the Republic of Armenia shall submit the results of the project assessment to the State Revenue Committee of the Republic of Armenia within ten days after the end date.
According to the information at the current moment, the commencement of mandatory labelling of medicines is expected to be 1 April 2025.
The operator of the system is CRPT Armenia https://e-mark.am/ru/products/medicine
Scope
- Vaccines for humans, put up for retail sale
- Medicinal products (other than those of heading 3002, 3005 or 3006), consisting of mixed or unmixed products, for therapeutic or prophylactic uses, put up in measured dosage forms (including medicaments in the form of transdermal systems) or in forms or packings for retail sale
- Contrast preparations for radiographic examinations; diagnostic reagents intended for administration to patients
- Chemical contraceptives based on hormones, other compounds of heading 2937 or spermicides
Armenia Pharmaceutical Market
The Armenian pharmaceutical industry is one of the key drivers of the country’s economy. The government recognized the potential of the sector and identified it as one of the five priority development areas in their comprehensive Government Action Plan for 2021-2026.
According to research, the pharmaceutical market is expected to achieve a revenue of USD $142.70 million in 2024. One of the largest sectors is Oncology Drugs which is projected to reach a market volume of USD $23.97million this year. Speaking from experience, it is expected the products from this sector will fall under the requirement for mandatory marking.
Armenia’s strategic location offers significant advantages for pharmaceutical companies, acting as a gateway to both regional and global markets and providing access to a broad customer base.
SoftGroup will continue following the journey of Armenia towards enhancement of the serialization and traceability. However, if you need more information regarding track and trace regulatory compliance in Armenia, schedule a free consultation with our expert >> communication@softgroup.eu
Sources:
https://www.statista.com/outlook/hmo/pharmaceuticals/armenia
