The population of Armenia is about 2.8 million people. Armenia is a landlocked country in the South Caucasus region with an economy driven by agriculture, mining, and a growing IT sector. The official language is Armenian, but Russian is widely spoken and understood, particularly in business and government settings.

Healthcare expenditure accounts for approximately 8-10% of the national budget. The pharmaceutical market in Armenia is valued at about $200 million, with imports making up over 85% of the market. The market for medical devices and diagnostics is smaller but expanding, estimated at $50 million.

Medicines and medical devices must undergo state registration before being marketed in Armenia. Marketing Authorizations and approvals are granted by the authorized bodies.

Competent authorities:

• Ministry of Health of the Republic of Armenia: Regulates healthcare policies and oversees the registration and monitoring of medicines and medical devices.
  Website: https://www.moh.am/
• Scientific Center of Drug and Medical Technology Expertise: Responsible for state registration, expertise, and safety monitoring of medicinal products and medical devices.
  Website: https://pharm.am/

Main legislative acts:

1. Law of the Republic of Armenia “On Medicines” No. HO-89-N, dated December 27, 1996.
2. Government Decree No. 586-N, dated May 4, 2009, “On the Procedure of State Registration and Expertise of Medicines and Medical Devices.”
3. Order of the Ministry of Health No. 294-N, dated August 31, 2012, “On Licensing of Pharmaceutical Activity.”
4. Resolution No. 2299-N, dated December 22, 2011, “On Pharmacovigilance and Adverse Reaction Reporting.”

Armenia continues to modernize its healthcare system, with increasing investments in public health infrastructure and regulatory frameworks to meet international standards. Let me know if you need further details!