
Decision of the EAEU of January 21, 2022 N 1 On the Rules for regulating the circulation of veterinary medicinal products in the customs territory of the Eurasian Economic...
Decision of the EAEU of January 21, 2022 N 1 "On the Rules for regulating the circulation of veterinary medicinal...
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The terms of validity of registrations of medicine products registered under the national procedure
Dear colleagues, We would like to inform you that on June 24, 2025, the Minister of Health of the Republic of...
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Changes to Decision N78 dated November 3, 2016 On the rules for the registration and assessment of medicinal products for medical use
We would like to inform you that, as June 21, 2025, the numerous changes to Decision No. 78 dated November...
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Order N3273-A of May 30, 2025 on acceptance of applications for state registration of medicines for human use in accordance with the temporary rule in Republic of Armenia and on...
http://www.pharm.am/index.php/en/orders/9876-order-n3273-a-of-may-30-2025-on-acceptance-of-applications-for-state-registration-of-medicines-for-human-use-in-accordance-with-the-temporary-rule-in-republic-of-armenia-and-on-repeal-of-order-n4896-a-of-september-11-2024-of-ministry-of-health (index.php/en/orders/9876-order-n3273-a-of-may-30-2025-on-acceptance-of-applications-for-state-registration-of-medicines-for-human-use-in-accordance-with-the-temporary-rule-in-republic-of-armenia-and-on-repeal-of-order-n4896-a-of-september-11-2024-of-ministry-of-health)
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Decree of the Government of the Republic of Armenia N 342-N of March 27, 2025 «On approving the rule for granting advertising permission for medicinal products, medical devices and therapeutic...
See hyperlink (File available in armenian) Decree of the Government of the Republic of Armenia N 342-N of March 27, 2025...
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Essential Medicines List 2025
Essential Medicines List 2025 (index.php/en/essential-medicines)
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Decision EAEU N88 of November 03, 2016 on the Adoption of the Requirements for the Medication Guide and Summary of Product Characteristics of medicinal products for human use
http://www.pharm.am/index.php/en/the-eaeu-rules-of-medicines-registration-and-assessments/5908-decision-eaeu-n88-of-november-03-2016-on-the-adoption-of-the-requirements-for-the-medication-guide-and-summary-of-product-characteristics-of-medicinal-products-for-human-use (index.php/en/the-eaeu-rules-of-medicines-registration-and-assessments/5908-decision-eaeu-n88-of-november-03-2016-on-the-adoption-of-the-requirements-for-the-medication-guide-and-summary-of-product-characteristics-of-medicinal-products-for-human-use)
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Decision of EAEU N78 of November 03, 2016 on the rules of medicines registration and assessments
http://www.pharm.am/index.php/en/the-eaeu-rules-of-medicines-registration-and-assessments/5113-decision-of-eaeu-n78-of-november-03-2016-on-the-rules-of-medicines-registration-and-assessments-and-decision-of-eaeu-n55-of-june-14-2016-on-the-making-changes-of-the-decision-of-eaeu-n78-of-november-03-2016 (index.php/en/the-eaeu-rules-of-medicines-registration-and-assessments/5113-decision-of-eaeu-n78-of-november-03-2016-on-the-rules-of-medicines-registration-and-assessments-and-decision-of-eaeu-n55-of-june-14-2016-on-the-making-changes-of-the-decision-of-eaeu-n78-of-november-03-2016)
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Decree of the Government of the Republic of Armenia N162-N of 28 February 2019 «On adopting the rules for state registration, re-registration, extension of the term of the certificate of...
Decree N162_N in english Decree of the Government of the Republic of Armenia N162-N of 28 February 2019 «On adopting the...
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Information about making changes and additions in Decree of the Government of the Republic of Armenia N162-N of February 28, 2019
Dear colleagues We would like to inform, that on December 8, 2024 entered into force Decree of the Government of the...
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Information regarding Order N312-N on approval of the rules of the Good Pharmacovigilance Practice in Republic of Armenia
Dear colleagues, We would like to inform you that, in accordance with the Order of the Minister of Health of the...
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Information about temporary rule of acceptance of applications for state registration of medicines by national procedure
Dear colleagues, We would like to inform you that according to the Order of the Minister of Health of the...
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Notification of a technical problem to INFO@ampra.am
Dear Colleagues We would like to inform you that on 19.08.2024 from 16:00 untill 20.08.2024 14:50 due to technical problems, it was...
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PLAN of inspections in compliance with the guideline of Good Manufacturing Practice of Eurasian Economic Union rules
Please, be informed that the plan of schedule of inspections of GMP compliance for the year of 2024 has been...
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Information about changes in the activities of “Center of Drug and Medical Technology Expertise” SNPO
Dear Colleagues We would like to inform you that the “Center of Drug and Medical Technology Expertise” SNPO has started its...
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List of documents required for determining the regulatory status of borderline products
To get a conclusion about the type of products (medicines, food supplements, hygiene products or medical products, etc.) it is...
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Information about medicines registration
Dear Colleagues. According to the order of the Ministry of Health of the Republic of Armenia N4639-A of October 04, 2022 ...
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Order on approval of the price list of paid services provided by the Scientific Center of Drug and Medical Technologies Expertise N 029-A-22 of February 14, 2022
http://www.pharm.am/index.php/en/orders/6951-order-on-approval-of-the-price-list-of-paid-services-provided-by-the-scientific-center-of-drug-and-medical-technologies-expertise-n-029-a-22-of-february-14-2022 (index.php/en/orders/6951-order-on-approval-of-the-price-list-of-paid-services-provided-by-the-scientific-center-of-drug-and-medical-technologies-expertise-n-029-a-22-of-february-14-2022)
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Laboratory of Medicines Quality Control
THE MAIN ACTIVITIES:
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Expertise of the medicine's quality and correspondence to the specification, which is carried out for the purposes of state registration,
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Laboratory quality analysis of imported (also as donation) and exported medicines,
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Control of the quality of medicines and other pharmaceutical products sampled during inspections of pharmacies or wholesalers,
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Laboratory analysis of medicines and substances by the request of the RA State Administration bodies,
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Examination of quality and safety of food,
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Bioequivalence study.
The laboratory was awarded with a certificate on quality managment system ISO 9001-2000 by Swiss SGS Company in 2003.
The laboratory takes part in the proficiency test which is held by World Health Organization (WHO) and International Federation of Pharmacists (FIP).
According to the warrant of acreditation board of December 30, 2008 the laboratory was given the right of performing food quality and biosafety control.
The laboratory was awarded with a certificate on quality management new system ISO 9001-2008 by “Quality Austria” International Company in December 2010.
«Analytical laboratory» branch of the «Scientific Centre of Drug and Medical Technologies Expertise after Academician E. Gabrielyan» CJSC on 21.04.2016 was accredited with ISO/IEC 17025:2017 international standard in quality expertise in the field of pharmaceutical testing (Certificate number AT-2043).
HEAD OF QUALITY CONTROL LABORATORY:
Naira Eloyan
Biochemistry
Phone: (+374 10) 23-72-61
Komitas 49/5, Yerevan, 0051, Republic of Armenia
E-mail:
LEGAL BASIS FOR ACTIVITY:
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Pharmacological Council
The Pharmacological Council was established by the order of the Minister of Health.
THE MAIN ACTIVITIES OF THE COUNCIL:
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Definition of the category (type) of pharmaceutical production,
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Evaluation of the expertise results of the pharmaceutical production’s documentations that are claimed for registration and submission of a decision on approval or denial of the state registration,
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Definition of the drug state in the process of registration (Prescribed only Medicine(PoM), Out-the-Counter(OTC), Essential Drugs or Controlled Drugs),
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Approval of the instruction on drug use.
CHAIRPERSON:
Elmira Amroyan
Medical Doctor, Pharmacologist, Professor, Doctor of Medical Science
Phone: (+374 60)83-00-73, (+374 10)23-08-96, (+374 10)23-16-82
E-mail:
LEGAL BASIS FOR ACTIVITY:
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Republic of Armenia Law "On narcotics and psychotropic substances"
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Republic of Armenia Law "On medical aid and population services"
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Decree of the Government of the Republic of Armenia N 1129-N of August 21, 2003
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Order of the Ministry of Health of the Republic of Armenia N25-N of May 17, 2017 «On adopting the rules on Good Clinical Practice»
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Board of Directors
ACTING DIRECTOR Naira Romanova Pharmacist Phone: (+374 60) 83-00-73, (+374 10) 23-08-96, (+374 10) 23-16-82 E-mail: |
DEPUTY DIRECTOR Lilit Ghazaryan Pharmacist, Ph.D. in Pharmaceutics Coordinates the work of the departments: 1. Expertise and Evaluation of Medicines, 2. Rational Use of Medicines and Professional Information, 3. Monitoring of Side and Adverse Effects of Medicinal Products.
Phone: (+374 60) 83-00-73, (+374 10) 23-08-96, (+374 10) 23-16-82 + 10 03 |
DEPUTY DIRECTOR Serob Karamyan Pharmacist, Ph.D. in Pharmaceutics Coordinates the work of the group: 1. Expertise and Evaluation of medical devices. Phone: (+374 60) 83-00-73, (+374 10) 23-08-96, (+374 10) 23-16-82 + 10 05 |
ADVISER Albert Sahakyan Pharmacist, Ph.D. in Pharmaceutics Phone: (+374 60) 83-00-73, (+374 10) 23-08-96, (+374 10) 23-16-82 + 10 06 E-mail: |
DIRECTOR ASSISTANT Anahit Aroyan Phone: (+374 60) 83-00-73, (+374 10) 23-08-96, (+374 10) 23-16-82 + 10 00 E-mail: |
IT MANAGER, NETWORK ADMINISTRATOR Armen Grigoryan Phone: (+374 60) 83-00-73, (+374 10) 23-08-96, (+374 10) 23-16-82 + 10 48 E-mail: |
- Details
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