THE MAIN ACTIVITIES:

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

 

HEAD OF THE DEPARTMENT:

Alisa Hayrapetyan

Pharmacist

Phone: (+374 10) 231682, 230896, 234732, 232091 131

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 narcotics and psychotropic substances" 

  4. Republic of Armenia Law "On medical aid and population services"

  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 168-N of February 28, 2019 «Օn adopting the rules of issuance a permission of clinical trials in the Republic of Armenia, assessment for this purpose, the lists of necessary documents and on repeal of the Decree of the Government of the Republic of Armenia N 63 of January 24, 2002»

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

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

  9. 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»

  10. 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»

  11. 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

  12. 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

  13. 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»

  14. Common Technical Documents of Medicinal Products Registration

  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