Decision of EAEU N78 of November 03, 2016 on the rules of medicines registration and assessments
Decision of EAEU N78 of November 03, 2016 on the rules of medicines registration and assessments (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)
more ...
Decision of EAEU N78 of November 03, 2016 on the rules of medicines registration and assessments (updated 20.11.25)
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)
more ...
Decree of the Government of the Republic of Armenia N 1328-A of September 18, 2025 on making changes in Decree of the Government of the Republic of Armenia N172-A of...
See hyperlink (File available in armenian) Decree of the Government of the Republic of Armenia N 1328-A of September 18, 2025...
more ...
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...
more ...
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...
more ...
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...
more ...
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)
more ...
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...
more ...
Essential Medicines List 2025
Essential Medicines List 2025 (index.php/en/essential-medicines)
more ...
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)
more ...
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)
more ...
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...
more ...
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...
more ...
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...
more ...
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...
more ...
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...
more ...
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...
more ...
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...
more ...
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...
more ...
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 ...
more ...
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)
more ...
Medical Devices
In accordance with the Government Decision No. 1795-N of the Republic of Armenia, dated November 24, 2022, expert evaluations and professional inspections in the field of state regulation of the circulation of medical devices (hereinafter referred to as MD) are conducted by the State Non-Profit Organization (SNPO) "Center of drug and medical technology expertise" of the Ministry of Health of the Republic of Armenia. The provisions for the regulation of MD circulation in Armenia are outlined in Chapter 10 of the Law of the Republic of Armenia on "Medical Assistance and Healthcare Services to the Population."
"Medical devices" refer to any instrument, apparatus, equipment, materials, and other products that are used for medical purposes either individually or in combination, as well as accessories necessary for the intended use of these products (including special software), which the manufacturer has intended for the prevention, diagnosis, treatment, medical rehabilitation, and monitoring of the human health status, conducting medical research, restoration, replacement, or alteration of the anatomical structure or physiological functions of the body, prevention or artificial termination of pregnancy, and whose functional purpose is not achieved through pharmacological, immunological, genetic, or metabolic interaction with the human body, although this may be assisted by pharmaceuticals.
Medical devices intended for in vitro diagnosis refer to any instrument, apparatus, equipment, materials, reagents, control standards, test substances, and other products used for medical purposes either individually or in combination, as well as the necessary accessories and special software required for their intended use, which the manufacturer has intended for use in in vitro testing of human biological samples to determine physiological or pathological conditions (congenital pathology, predisposition to a certain clinical condition or disease), tissue compatibility with a potential recipient, prediction of reactions to therapeutic effects, selection of therapeutic agents and (or) monitoring of treatment.
- Details
- Hits: 11941
Legislation
-
The Law of the Republic of Armenia on "Medical Assistance and Healthcare Services to the Population" — the provisions for the state regulation of the circulation of medical devices in the Republic of Armenia are defined in Chapter 10,
-
Agreement on "Unified Principles and Rules for the Circulation of Medical Devices (Medical Purpose Products and Medical Technology) within the Framework of the Eurasian Economic Union" dated December 23, 2014,
-
The Law of the Republic of Armenia on "State Duty",
-
The Law of the Republic of Armenia on "Licensing" ,
-
Decision No. 429-N of the Government of the Republic of Armenia on "The Procedure for Importing Medical Devices into the Territory of the Republic of Armenia and the List of Documents Required for Expert Evaluation of Medical Device Imports",
-
The EAEU Regulation on the Registration of Medical Devices, step-by-step registration process guide,
-
The EAEU Regulation on the Registration of Medical Devices: "Rules for the Registration of Medical Devices and the Examination of Their Safety, Quality, and Effectiveness" — Decision No. 46 of the Eurasian Economic Commission Council dated February 12, 2016, step-by-step registration process guide,
-
Decision No. 867 of the Government of the Republic of Armenia dated June 29, 2002, on "The Rules for Licensing the Production of Medicines, Pharmaceutical Activities, the Provision of Medical Assistance and Services by Organizations or Individual Entrepreneurs, Wholesale Distribution of Medicines, Production of Medical Devices, and the Maintenance of Medical Devices, and the Forms of Licenses for Such Activities", which defines the licensing procedures for the production and servicing of medical devices.
-
Decision No. 29 of the Eurasian Economic Commission Council on "Rules for Clinical and Clinical-Laboratory Trials (Research) of Medical Devices" dated February 12, 2016,
-
The regulatory acts and decisions of the Eurasian Economic Commission (EEC) governing this sector are available on the official EEC website, and they are also published in Armenian on the arlis.am platform.
- Details
- Hits: 5867
