The terms of validity of registrations of medicine products registered under the national procedure

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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

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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...

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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

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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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PLAN of inspections in compliance with the guideline of Good Manufacturing Practice of Eurasian Economic Union rules

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List of documents required for determining the regulatory status of borderline products

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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

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THE MAIN ACTIVITIES:

  1. Expertise of the accompanying documentation for the pharmaceutical production while import/export into or out of RA,

  2. Sampling of drugs at the customs, while import,

  3. Identification of the imported production’s samples correspondence to the registration samples,

  4. Submission to MoH RA of the expert report on the drugs export/import.

 

HEAD OF THE DEPARTMENT:

Anna Tsaghikyan

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 licensing"

  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 202-N of February 28, 2019 «Օn adopting the rule on importation in the Republic of Armenia and exportation from the Republic of Armenia of medicinal products, active substance, herbal substance and investigational medicinal products , the rule on assessment for the propose of importation and exportation and the list of necessary documents as well as on repeal of the Decree of the Government of the Republic of Armenia N 581 of September 20, 2000»

  6. Decree of the Government of the Republic of Armenia N 1127-N of September 12, 2019 on making additions and changes in Decree of the Government of the Republic of Armenia N202-N of February 28, 2019

  7. Decree of the Government of the Republic of Armenia N 1302-N of August 06, 2020 on making additions in Decree of the Government of the Republic of Armenia N202-N of February 28, 2019

  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 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

THE MAIN ACTIVITIES:

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

 

ACTIING HEAD OF THE DEPARTMENT:

Rita Sargsyan

Pharmacist

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

  4. Republic of Armenia Law "On licensing"

  5. 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»

  6. 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»

  7. 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»

  8. Decree of the Government of the Republic of Armenia N 1196-N of September 25, 2008, «On adopting the maximum residual quantities of veterinary medicines in the food of animal origin»

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

  10. Decree of the Government of the Republic of Armenia N 867 of June 29, 2002

  11. Decree of the Government of the Republic of Armenia N716-N of June 23, 2017 on approval of the list of the acting Pharmacopoeias in the Republic of Armenia  

  12. Decree of the Government of the Republic of Armenia N 172-A of February 23, 2017 «Օn determination of the international organization as defined by the Law "On Medicines" of the Republic of Armenia

  13. 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

  14. 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

  15. Order of the Minister of Health of the Republic of Armenia N 02-N of January 19, 2015, on making changes in 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

  16. Order of Minister of Health of the Republic of Armenia N31–N of 10 June 2019 on adopting the form of state registration certificate of medicinal products, the structure of register and operational rule of it, the rule for determining the classification of the medicinal product to the class of prescription and non-prescription medicinal products and its revision in the Republic of Armenia and on repealing the order of Minister of Health of the Republic of Armenia N123 of 7 February 2006

  17. Common Technical Documents of Medicinal Products Registration

  18. Variation Guideline

  19. Order of the Ministry of Health of Republic of Armenia N3339-A, of November 22, 2017 on using decision N46 of February 12, 2016 of the Council of the Eurasian Economic Commission

  20. 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

  21. 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

  22. 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

  23. Republic of Armenia Law "On state duty"

 

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