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 new assesments fees procedure


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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 of Minister of Health of the Republic of Armenia N 4639-A of October 04, 2022 «On establishing a temporary procedure for submitting applications for state registration of medicinal products...


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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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Pharmacovigilance Department

THE MAIN ACTIVITIES:

  1. Monitoring of adverse drug reactions (ADR) including collection, evaluation and management of ADR data.

  2. Monitoring of other medicine-related safety issues including collection, evaluation and management of information related to quality, lack of efficacy, and counterfeiting of medicines.

  3. Maintaining  the national database of adverse drug reactions

  4. Expertise of risk management plan (RMP) and managing the risk minimization measures.

  5. Expertise and confirmation of publishing information related to safety of medicines.

  6. Expertise of periodic safety update reports (PSUR)

  7. Signal detection and management

  8. Expertise of post-registration safety variations.

  9. Provision of safety report for regulatory decisions

  10.  Provision of  safety communication

  11.  Development of educational and training materials to raise awareness on medicine safety

  12. Publishing “Safety of medicines” bulletin

  13.  Screening of literature and other sources on medicine safety

  14. Accepting public inquiries on ADRs and medicine-related other safety issues and providing feedbacks by  hot-line route

 

HEAD OF THE DEPARTMENT:

Narine Hovhannisyan

Physician

Phone: (+374 60)83-00-73, (+374 10)23-08-96, (+374 10)23-16-82

Hot Line: (+374 10) 20-05-05, (+374 96) 22-05-05

E-mail: narineh@pharm.am; vigilance@pharm.am

  

LEGAL BASIS FOR ACTIVITY:

  1. Republic of Armenia Law "On Medicines

  2. 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»

  3. 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»

  4. 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»

  5. Order of the Ministry of Health of the Republic of Armenia N23-N of May 17 2017 on approving “The order of recording and reporting cases of adverse reactions, lack of effectiveness, misuse and suspect on falsification of medicines; collecting, reporting, monitoring, submitting reports and analyzing data on adverse reactions of medicines, approving the form of the register of adverse reaction and form of reporting of adverse reactions, lack of effectiveness, misuse and suspect on falsification of medicines

  6. 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

 

DRUG SAFETY MONITORING

 

 

 

 

 

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