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

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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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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THE MAIN ACTIVITIES:

  1. Organization of the center’s external and internal documentations circulation,

  2. Keeping contact with the applicants,

  3. Duties related to registration certificates,

  4. Duties related to order of minister of  health regarding registration, cancellation and refusal of registration of medicinal products,

  5. Duties related to official e-mail () of the Centre,

  6. Duties related to applications or letters for registration of vital medicinal products with low need,

  7. Archiving of the documentation.

 

HEAD OF THE DEPARTMENT:

Meri Zakaryan

Economist

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 state duty"

  3. 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»

  4. Decree of the Government of the Republic of Armenia N 162-N of February 28, 2019 «On adopting the rules for medicinal product state registration, reregistration, extension of the registration certificate, to refuse registration, reregistration, extension of the registration certificate, suspension of registration, withdraw of registration, the rules of the assessment for these proposes as well as the rule of post registration changes’ submission and assessment, the list of necessary documents, the list of changes of the registered medicinal products do not require new registration, the rule of inspection and recognition of other countries competent authorities inspection reports and on repeal of the Decree of the Government of the Republic of Armenia N 347 of April 25, 2001»

  5. 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»

  6. Order of the Minister of Health of the Republic of Armenia N 22-N of November 20, 2008, on adopting the list of low demand but vital medicines

  7. Order of the Minister of Health of the Republic of Armenia N 22-N of November 20, 2008, on adopting the list of low demand but vital medicines amended by the Order of the Minister of Health of the Republic of Armenia N 02-N of January 19, 2015

  8. 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