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 ...

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 ...

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 ...
0123456789101112131415161718

 

THE MAIN ACTIVITIES:

Regulation of the process of acquisition of goods, works and services for needs of Scientific Centre of Drug and Medical Technology Expertise after academician E.Gabrielyan.

 

HEAD OF THE DEPARTMENT:

Marine Petrosyan

Jurist

Phone: (+374 60)83-00-73,  (+374 10)23-08-96, (+374 10)23-16-82+10 07

E-mail:

 

LEGAL BASIS FOR ACTIVITY:

  1. Republic of Armenia Law "On Procurement"

  2. Decree of the RA N 386-N of 6 April 2017 «On approving the procedure for carring out E-procurement and repealing decree No 1370-N of 5 december 2013 of the Goverment of the RA»

  3. Decree of the RA N 526-N of 4 May 2017 «On approving the procedure for organisation of the procurement process and repealing decree of the Government of the RA No 168-N Of 10 february 2011»

  4. Decree of the Government of thy RA N 759-N of 29 June 2017 «On approving the procedure for conferring qualification on procurement co-ordinators and continuous professional training thereof and repealing decree of the Government of the RA No 99-N of 12 february 2015»

THE MAIN ACTIVITIES:

The main functions are expertise and evaluation of  medical technologies and devices submitted for registration in RA.

 

HEAD OF THE DEPARTMENT:

Davit Davtyan

chemist

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

E-mail:

 

LEGAL BASIS FOR ACTIVITY:

Order of the Ministry of Health of Republic of Armenia N3339-A, of November 22, 2017 on using decision N46 of February 12, 2017 of the Eurasian Economic Commission

Order of the Ministry of Health of Republic of Armenia N3398-A, of November 30, 2017 on using decision N29, N42 of February 12, 2016 and N38 of May 12, 2016 of the Council of the Eurasian Economic Commission

Order of the Ministry of Health of Republic of Armenia N3399-A, of November 30, 2017 on using decision N173, N174 of December 22, 2015 and N177 of December 29, 2015 of the Board of the Eurasian Economic Commission

          The mission of the Centre of Drug and Medical Technology Expertise is to implement the national drug policy, to ensure the safety, efficacy and quality of medicinal products in RA. According to the recommendations of the World Health Organization (WHO), The Scientific Centre of Drug and Medical Technology Expertise (SCDMTE) was founded in 1992 as an organization with managerial, financial and technical independence which is accountable to the Ministry of Health of the RA. 

 

THE MAIN ACTIVITIES OF THE CENTRE

  1. Expertise and evaluation. Expert assessment of medicines (including veterinary drugs), herbal drugs, medical cosmetics, medical devices with the purpose of state registration.

  2. Expertise of import and export. Professional expertise of medicines for certification of their import and export.

  3. Specialized expertise of pharmaceutical organizations for assuring the appropriate quality of medicines and other pharmaceutical products, available at the pharmaceutical market of Armenia, as well as detecting counterfeit drugs.

  4. Control over Narcotics and Psychotropic Substances. Calculation of an annual demand (quota) of narcotics and psychotropic substances in RA, certification of import and export of narcotics and psychotropic substances and submission of reports to UN International Narcotics Control Board.

  5. Monitoring adverse effects of drugs. Registration of adverse drug reactions in the RA and provision of relevant information to the WHO International Program on Monitoring Adverse Drug Reactions (Uppsala, Sweden).

  6. Implementation of the concept of rational use of drugs. Participation in the Review of the National Essential Medicines List, development of optimal schemes of pharmacotherapy, study of drug prescription practice, carrying out the pharmaco-epidemiological researches.

  7. Control of clinical trials. Expertise of protocols and other required documents with the purpose of clinical trials in RA, as well as monitoring of current clinical trials.

  8. Informational and publishing activity. Publication of contemporary, objective information on pharmacotherapy, medicines and other pharmaceutical products, as well as guide books, manuals and formularies.

  9. Legislative activity. Participation in the development of the legislative documents related to National drug policy and its implementation.

  10. Research activity. Conduction of studies in the field of medicine and pharmacy, surveys of pharmaceutical market, pharmaco-economic analysis. The Centre has functioning Scientific Board.

  11. Educational activity. Organization of educational workshops and seminars, also in cooperation with WHO and other international organizations.

  12. Skill formation and advanced training. Participation in under- and post-graduate educational programs.

The Centre employs more than 80 experts of pharmacology, clinical pharmacology, pharmacy, toxicology, chemistry, and biotechnology. They regularly participate in the international conferences and advanced trainings. 

The Centre has a well-equipped laboratory of drug quality control. 

The Centre has observer status in European Pharmacopoeia Commission since 2009. 

The activity of the Centre has been highly evaluated by WHO and other international organizations.