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:

Kristine Davtyan

Pharmacist

Phone: (+374 10) 231682, 230896, 234732, 232091 224

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 63 of January 24, 2002, on establishing «The order of conducting clinical tests of new medicines in the RA»

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

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

  8. Decree of the Government of the Republic of Armenia N 347 of April 25, 2001

  9. Order оf the MoH оf the RA N123-N of 07.02.2006, on approving «The order of conducting expert examination of medicines with purpose of state registration in the RA, the table of minimum quantity of submitted samples of medicines attached with application, the conclusion form of the examination of а medicine with the purpose of registration, the form and description of the state registration certificate, the list of changes of medicines registered in the Republic of Armenia that do not require new registration”.

  10. Order of the Minister of Health of the Republic of Armenia N 17-N of May 14, 2013 and Order on making changes N80-A 22 January, 2014

  11. Requirements to the State Registration

  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