Armenia Proposes Amendments to the Law on Medicines: What Will Change for Imports, Warehouses, and Manufacturers?
21.05.2026,
12:45
Armenia is proposing amendments and additions to the Law "On Medicines" aimed at clarifying the regulation of drug circulation, strengthening quality and safety controls, and increasing access to medications.
YEREVAN, May 21. /ARKA/. Armenia is proposing amendments and additions to the Law "On Medicines" aimed at clarifying the regulation of drug circulation, strengthening quality and safety controls, and increasing access to medications. Deputy Minister of Health Astghik Grigoryan presented the amendments at a meeting of the Standing Committee on Health of the National Assembly of Armenia.
As noted in the rationale, the adoption of the draft is driven by the need to eliminate discrepancies in current legislation, improve the effectiveness of control mechanisms, and harmonize Armenian regulations with those in force within the Eurasian Economic Union.
One of the key changes concerns drug manufacturers and suppliers. It is proposed to clarify the procedure for issuing certificates of compliance with good manufacturing and good distribution practices. Specifically, the first certificate will be issued based on general monitoring after obtaining a license, followed by ongoing inspections at enterprises and warehouses.
The draft also revises the grounds for suspending and terminating licenses. Specifically, a license to manufacture drugs may be terminated if the drug is produced without a Good Manufacturing Practices (GMP) certificate. Similar measures are proposed for the wholesale distribution of drugs without a GMP certificate.
A separate set of amendments concerns the import of drugs. The draft proposes allowing the import of certain unregistered drugs included in the list of essential drugs, as well as antineoplastic and immunomodulatory drugs used in oncology. The rationale notes that ensuring that only registered drugs from the GMP list are available on the market is impossible, as registration has a limited period, and some registered drugs have not been imported for long periods and are effectively absent from the market.
It also proposes clarifying the grounds for denial of an import certificate. These grounds include violations of transportation or storage conditions, including temperature control and cold chain management; damaged packaging; recall of the drug for safety, efficacy, or quality reasons; and obstruction of the collection of samples for examination.
Furthermore, the draft clarifies the regulation of parallel imports. Importers will be able to apply to the authorized body for preliminary parallel import permission before ordering and transporting a drug. However, such permission will not be a prerequisite for obtaining an import certificate.
Significant changes are also proposed for customs warehouses. According to the draft, customs and other warehouses, as well as temporary storage areas where drugs, pharmaceutical substances, medicinal plant materials, or investigational pharmaceutical products are stored, will be required to comply with licensing and certification requirements for proper distribution activities. This provision will be deferred until six months after the official publication of the law.
The draft also stipulates that after the adoption of post-registration changes unrelated to quality, efficacy, and safety, drugs in previously approved packaging may be sold if they were made before the adoption of the change or within 180 calendar days thereafter.
Another amendment concerns drug advertising: the law is proposed to remove the requirement to include information about the state registration of a drug in advertisements, as this information is verified by the authorized body when issuing an advertising permit.
The draft law was developed by the Ministry of Health of Armenia, its Legal Department, the Department of Drug Policy and Medical Technologies, and the Expert Center for Drugs and Medical Technologies of the Ministry of Health.
According to the conclusion, the adoption of the draft law does not entail a significant reduction in revenue or an increase in expenditures for the state budget of Armenia.
The commission gave a positive opinion to the draft law. It has been included in the agenda of the National Assembly of Armenia.
As noted in the rationale, the adoption of the draft is driven by the need to eliminate discrepancies in current legislation, improve the effectiveness of control mechanisms, and harmonize Armenian regulations with those in force within the Eurasian Economic Union.
One of the key changes concerns drug manufacturers and suppliers. It is proposed to clarify the procedure for issuing certificates of compliance with good manufacturing and good distribution practices. Specifically, the first certificate will be issued based on general monitoring after obtaining a license, followed by ongoing inspections at enterprises and warehouses.
The draft also revises the grounds for suspending and terminating licenses. Specifically, a license to manufacture drugs may be terminated if the drug is produced without a Good Manufacturing Practices (GMP) certificate. Similar measures are proposed for the wholesale distribution of drugs without a GMP certificate.
A separate set of amendments concerns the import of drugs. The draft proposes allowing the import of certain unregistered drugs included in the list of essential drugs, as well as antineoplastic and immunomodulatory drugs used in oncology. The rationale notes that ensuring that only registered drugs from the GMP list are available on the market is impossible, as registration has a limited period, and some registered drugs have not been imported for long periods and are effectively absent from the market.
It also proposes clarifying the grounds for denial of an import certificate. These grounds include violations of transportation or storage conditions, including temperature control and cold chain management; damaged packaging; recall of the drug for safety, efficacy, or quality reasons; and obstruction of the collection of samples for examination.
Furthermore, the draft clarifies the regulation of parallel imports. Importers will be able to apply to the authorized body for preliminary parallel import permission before ordering and transporting a drug. However, such permission will not be a prerequisite for obtaining an import certificate.
Significant changes are also proposed for customs warehouses. According to the draft, customs and other warehouses, as well as temporary storage areas where drugs, pharmaceutical substances, medicinal plant materials, or investigational pharmaceutical products are stored, will be required to comply with licensing and certification requirements for proper distribution activities. This provision will be deferred until six months after the official publication of the law.
The draft also stipulates that after the adoption of post-registration changes unrelated to quality, efficacy, and safety, drugs in previously approved packaging may be sold if they were made before the adoption of the change or within 180 calendar days thereafter.
Another amendment concerns drug advertising: the law is proposed to remove the requirement to include information about the state registration of a drug in advertisements, as this information is verified by the authorized body when issuing an advertising permit.
The draft law was developed by the Ministry of Health of Armenia, its Legal Department, the Department of Drug Policy and Medical Technologies, and the Expert Center for Drugs and Medical Technologies of the Ministry of Health.
According to the conclusion, the adoption of the draft law does not entail a significant reduction in revenue or an increase in expenditures for the state budget of Armenia.
The commission gave a positive opinion to the draft law. It has been included in the agenda of the National Assembly of Armenia.
