Armenia has introduced new drug control mechanisms in accordance with EAEU standards
03.07.2026,
14:14
At an extraordinary session on Friday, the National Assembly of Armenia adopted amendments to the Law "On Medicines" in the second and final reading.
YEREVAN, July 3. /ARKA/. At an extraordinary session on Friday, the National Assembly of Armenia adopted amendments to the Law "On Medicines" in the second and final reading.
As the keynote speaker, RA Deputy Minister of Health Astghik Grigoryan, stated, the goal is to eliminate discrepancies in drug regulation, introduce clearer tools for ensuring and monitoring the quality, safety, and availability of medicines, and ensure the harmonization of national regulations with EAEU requirements and regulations.
"In particular, with this amendment to the law, we propose expanding the list of drugs produced in organizations providing medical care and services for which, according to EAEU requirements, registration is not required. We also propose allowing the import of unregistered drugs included in the list of essential medicines, which also applies to drugs used in oncology. "In the event of non-compliance with the registration form, they should be relabeled with a sticker under the conditions established by law," Grigoryan said.
She noted that it is proposed to clarify the grounds for refusing importation in order to reduce the risks of using drugs that do not meet established requirements, as well as to refine the grounds for suspending and terminating licenses for the production and distribution of drugs, expanding the powers of the licensing authority.
The law also proposes to establish a mandatory wholesale license and a certificate of proper distribution for customs warehouses storing pharmaceutical products. This amendment proposes to extend this regulation to pharmaceutical warehouses operating under the jurisdiction of other agencies that import, export, and distribute drugs.
As the keynote speaker, RA Deputy Minister of Health Astghik Grigoryan, stated, the goal is to eliminate discrepancies in drug regulation, introduce clearer tools for ensuring and monitoring the quality, safety, and availability of medicines, and ensure the harmonization of national regulations with EAEU requirements and regulations.
"In particular, with this amendment to the law, we propose expanding the list of drugs produced in organizations providing medical care and services for which, according to EAEU requirements, registration is not required. We also propose allowing the import of unregistered drugs included in the list of essential medicines, which also applies to drugs used in oncology. "In the event of non-compliance with the registration form, they should be relabeled with a sticker under the conditions established by law," Grigoryan said.
She noted that it is proposed to clarify the grounds for refusing importation in order to reduce the risks of using drugs that do not meet established requirements, as well as to refine the grounds for suspending and terminating licenses for the production and distribution of drugs, expanding the powers of the licensing authority.
The law also proposes to establish a mandatory wholesale license and a certificate of proper distribution for customs warehouses storing pharmaceutical products. This amendment proposes to extend this regulation to pharmaceutical warehouses operating under the jurisdiction of other agencies that import, export, and distribute drugs.
