Medicines Registration Department

THE MAIN ACTIVITIES:

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

 

HEAD OF THE DEPARTMENT:

Naira Romanova

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"