Pharmacological Council

The Pharmacological Council was established by the order of the Minister of Health.

THE MAIN ACTIVITIES OF THE COUNCIL:

  1. Definition of the category (type) of pharmaceutical production,

  2. Evaluation of the expertise results of the pharmaceutical production’s documentations that are claimed for registration and submission of a decision on approval or denial of the state registration,

  3. Definition of the drug state in the process of registration (Prescribed only Medicine(PoM), Out-the-Counter(OTC), Essential Drugs or Controlled Drugs),

  4. Approval of the instruction on drug use.

 

CHAIRPERSON:

Elmira Amroyan

Medical Doctor, Pharmacologist, Professor, Doctor of Medical Science. Head of the Department of Clinical pharmacology of the National Institute of the MoH RA.

Phone: (+374 10) 232091, 231682, 230896 109

E-mail:

 

LEGAL BASIS FOR ACTIVITY:

  1. Republic of Armenia Law "On Medicines"

  2. Republic of Armenia Law "On narcotics and psychotropic substances"

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

  4. 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»

  5. 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»

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

  7. 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»

  8. 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»

  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 07-N of April 13, 2018 on approving the "Essential Medicines List" and Order on making changes N14-N of May 31, 2018                            

  11. Order of the Minister of Health of the Republic of Armenia N 21-N of November 15, 2011, «On adopting the credentials of the Pharmacological Council of the MoH»

  12. Order of the Ministry of Health of the Republic of Armenia N25-N of May 17, 2017 «On adopting the rules on Good Clinical Practice»