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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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

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Decision of EAEU N78 of November 03, 2016 on the rules of medicines registration and assessments

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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

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Information about temporary rule of acceptance of applications for state registration of medicines by national procedure

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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

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Information about changes in the activities of “Center of Drug and Medical Technology Expertise” SNPO

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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

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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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The Pharmacological Council was established by the order of the Minister of Health.

THE MAIN ACTIVITIES OF THE COUNCIL:

  1. Definition of the category (type) of pharmaceutical production,

  2. 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,

  3. Definition of the drug state in the process of registration (Prescribed only Medicine(PoM), Out-the-Counter(OTC), Essential Drugs or Controlled Drugs),

  4. 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:

  1. Republic of Armenia Law "On Medicines"

  2. Republic of Armenia Law "On narcotics and psychotropic substances"

  3. Republic of Armenia Law "On medical aid and population services"

  4. Decree of the Government of the Republic of Armenia N 150-N February 28, 2019, «On designation a body responsible for organization and conduction the assessment and inspection in the field of state regulation of medicinal products circulation»

  5. Decree of the Government of the Republic of Armenia N 168-N of February 28, 2019 «Օn adopting the rules of issuance a permission of clinical trials in the Republic of Armenia, assessment for this purpose, the lists of necessary documents and on repeal of the Decree of the Government of the Republic of Armenia N 63 of January 24, 2002»

  6. Decree of the Government of the Republic of Armenia N 1129-N of August 21, 2003

  7. 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 medicinal product, as well as for refusal of registration, re-registration and of extension of the term of the certificate, for suspension of registration, withdrawal thereof, the rules for carrying out assessments for these purposes, as well as the rule for the submission and assessment of post-registration changes, the list of required documents, the list of changes of registered medicinal product which do not require new registration, the rule for inspection and for recognition of inspection reports of competent authorities of other countries, in the Republic of Armenia, and on repealing the decree of the Government of the Republic of Armenia N347 of 25 April 2001»

  8.  Decree of the Government of the Republic of Armenia N 166-N of February 28, 2019 «On adopting the fees in the Republic of Armenia for assessments in the field of medicinal products state regulation»

  9.  Order of the Minister of Health of the Republic of Armenia N 07-N of April 13, 2018 on approving the "Essential Medicines List" and Order on making changes N14-N of May 31, 2018

  10. 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»