The Pharmacological Council was established by the order of the Minister of Health.
THE MAIN ACTIVITIES OF THE COUNCIL:
Definition of the category (type) of pharmaceutical production,
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,
Definition of the drug state in the process of registration (Prescribed only Medicine(PoM), Out-the-Counter(OTC), Essential Drugs or Controlled Drugs),
Approval of the instruction on drug use.
CHAIRPERSON:
Elmira Amroyan
Medical Doctor, Pharmacologist, Professor, Doctor of Medical Science
Phone: (+374 60)83-00-73, (+374 10)23-08-96, (+374 10)23-16-82
E-mail:
LEGAL BASIS FOR ACTIVITY:
Republic of Armenia Law "On Medicines"
Republic of Armenia Law "On narcotics and psychotropic substances"
Republic of Armenia Law "On medical aid and population services"
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»
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»
Decree of the Government of the Republic of Armenia N 1129-N of August 21, 2003
Decree of the Government of the Republic of Armenia N162-N of 28 February 2019 «On adopting the rules for state registration, re-registration, extension of the term of the certificate of medicinal product, as well as for refusal of registration, re-registration and of extension of the term of the certificate, for suspension of registration, withdrawal thereof, the rules for carrying out assessments for these purposes, as well as the rule for the submission and assessment of post-registration changes, the list of required documents, the list of changes of registered medicinal product which do not require new registration, the rule for inspection and for recognition of inspection reports of competent authorities of other countries, in the Republic of Armenia, and on repealing the decree of the Government of the Republic of Armenia N347 of 25 April 2001»
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»
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
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»
Details
Published: 06 November 2014
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