THE MAIN ACTIVITIES:

  1. Monitoring of the activity of pharmacies and wholesalears,

  2. Specialized expertise held on the production process of the local pharmaceutical manufactures.

 

HEAD OF THE DEPARTMENT:

Mkrtich Shakaryan

Pharmacist

Phone: (+374 10) 231682, 230896, 234732, 232091 117

E-mail:

 

LEGAL BASIS FOR ACTIVITY:

  1. Republic of Armenia Law "On Medicines"

  2. Republic of Armenia Law "On licensing"

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

  4. 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”.

  5. Order of the Minister of Health of the Republic of Armenia N 03-A of March 4, 2008 on adopting sanitary rules and norms N 2.1.3-3 «Hygienic and antiepidemic demands to the usage of medical wastes in RA»

  6. Decree of the Government of the Republic of Armenia N 1603-N of November 25 2010, «Rules of Good Manufacturing Practice»

  7. Decree of the Government of the Republic of Armenia №734-N of 28 May, 2011 on approving implementation schedule of the rules of Good Manufacturing Practices (GMP) and realization of reforms in medicines circulation in the Republic of Armenia

  8. Order of the Minister of Health of the Republic of Armenia N1325-A of July 8, 2011, «On adopting the list of necessary legal acts and program of implementation of the Quality management system required for the activity of the GMP/GDP inspection department

  9. Order of the Minister of Health of the Republic of Armenia N2337-A of November 15, 2011, «On adopting Good Manufacturing Practice compliance inspection procedure and report form»

  10. Order of the MoH of the RA N303-A of 24 February 2012, «On adopting the procedure on withdrawn, suspension and recall of the medicines, drug substances, medical devices and dietary active supplements, rapid alert and rapid alert follow up notification»

  11. Convention on collaboration in the struggling against the counterfeit medicinal products circulation

  12.  Decree of the Government of the Republic of Armenia N 1089-N of September 26, 2013 «On adopting the rules of conducting GMP compliance inspection and certification of the medicinal products and APIs in the RA»

  13. Decree of the Government of the Republic of Armenia N 724-N of July 4, 2013, «On adopting the check lists of risk based inspection on assuring mandatory requirements of importers, exporters and entities carrying out pharmaceutical activity»

  14. Order of the Minister of Health of the Republic of Armenia N 05-N of February 1, 2013, «On adopting the rules of medical waste management in pharmacies and pharmaceutical outlets»

  15. Order of the Minister of Health of the Republic of Armenia N 189-A of February 06, 2014, «On adopting the GMP compliance inspection fee»

  16. Order of the Minister of Health of the Republic of Armenia N 18-N of May 20, 2013, «On adopting the rules for recall and disposal of the medicinal products failed to meet specification(s) defined by RA legislation»

  17. Order of the Minister of Health of the Republic of Armenia 1324-A, July 8, 2011

  18. Order of the Minister of Health of the Republic of Armenia 1395-A, June 15, 2012

  19. Order of the Minister of Health of the Republic of Armenia 1396-A, June 15, 2012

  20. Order of the Minister of Health of the Republic of Armenia 1613-A, July 8, 2014