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 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 867 of June 29, 2002

  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 199-N of February 28, 2019 «Օn adopting the rules of compliance inspection with the requirements of Good Manufacturing Practice of medicinal products and pharmaceutical substance, the issuance of the Good Manufacturing Practice Certificate, as well as the assessment rule for the purpose of licensing the manufacturing of medicinal products and the list of necessary documents; and on repeal of the Decree of the Government of the Republic of Armenia N 1603-N of November 25, 2010 and the Decree of the Government of the Republic of Armenia N 1089-N of September 23, 2013»

  7. Decree of the Government of the Republic of Armenia N 156-N of February 28, 2019 «Օn adopting the rules of inspection in the scope of distributor certification and issuance a Good Distribution Practice certificate, the assessment rule for the purpose of licensing the medicinal products wholesale realization and the list of necessary documents in the Republic of Armenia»

  8. 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

  9. 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

  10. 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»

  11. Decree of the Government of the Republic of Armenia N 164-N of February 28, 2019 «Օn adopting the procedures in the Republic of Armenia related to rapid alert, termination of circulation and recall of nonregistered, non-conforming quality requirements, expired, registration withdrawal or suspended medicinal products, counterfeit medicinal products, active substance, herbal substances, investigational medicinal products and medicinal products imported in violation of the legislation of the Republic of Armenia»

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

  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 1324-A, July 8, 2011

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

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

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