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THE MAIN ACTIVITIES:

  1. Expertise of the medicine's quality and correspondence to the specification, which is carried out for the purposes of state registration,

  2. Laboratory quality analysis of imported (also as donation) and exported medicines,

  3. Control of the quality of medicines and other pharmaceutical products sampled during inspections of pharmacies or wholesalers,

  4. Laboratory analysis of medicines and substances by the request of the RA State Administration bodies,

  5. Examination of quality and safety of food,

  6. Bioequivalence study.

 

The laboratory was awarded with a certificate on quality managment system ISO 9001-2000 by Swiss SGS Company in 2003.

The laboratory takes part in the proficiency test which is held by World Health Organization (WHO) and International Federation of Pharmacists (FIP). 

According to the warrant of acreditation board of December 30, 2008 the laboratory was given the right of performing food quality and biosafety control. 

The laboratory was awarded with a certificate on quality management new system ISO 9001-2008 by “Quality Austria” International Company in December 2010. 

«Analytical laboratory» branch of  the «Scientific Centre of Drug and Medical Technologies Expertise after Academician E. Gabrielyan» CJSC on 21.04.2016 was accredited with ISO/IEC 17025:2017 international standard in quality expertise in the field of pharmaceutical testing (Certificate number AT-2043).


 

 

 

HEAD OF QUALITY CONTROL LABORATORY:

Naira Eloyan

 Biochemistry

Phone: (+374 10) 23-72-61

 

 

Komitas 49/5, Yerevan, 0051, Republic of Armenia

E-mail: 

 

LEGAL BASIS FOR ACTIVITY:

  1. Republic of Armenia Law "On Medicines"

  2. 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»

  3. 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»

  4. 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»

  5. Decree of the Government of the Republic of Armenia N 202-N of February 28, 2019 «Օn adopting the rule on importation in the Republic of Armenia and exportation from the Republic of Armenia of medicinal products, active substance, herbal substance and investigational medicinal products , the rule on assessment for the propose of importation and exportation and the list of necessary documents as well as on repeal of the Decree of the Government of the Republic of Armenia N 581 of September 20, 2000»

  6. 11 August, 2005, N1217-N decree of the government of the Republic of Armenia on the foundation of a state licensed body on monitoring the import of foods (honey) having organic origin

  7. Order on approval of the price list of paid services provided by the Scientific Center of Drug and Medical Technologies Expertise N 029-A-22 of February 14, 2022

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

Phone: (+374 60)83-00-73, (+374 10)23-08-96, (+374 10)23-16-82

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 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»

  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 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

  10. 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»             

     

ACTING DIRECTOR

Naira Romanova

Pharmacist

Phone: (+374 60) 83-00-73,  (+374 10) 23-08-96, (+374 10) 23-16-82 

E-mail: 

DEPUTY DIRECTOR

Lilit Ghazaryan

Pharmacist, Ph.D. in Pharmaceutics

Coordinates the work of the departments:

1.      Expertise and Evaluation of Medicines,

2.      Rational Use of Medicines and Professional Information,

3.      Monitoring of Side and Adverse Effects of Medicinal Products.

 

Phone: (+374 60) 83-00-73,  (+374 10) 23-08-96, (+374 10) 23-16-82 + 10 03

E-mail:

DEPUTY DIRECTOR

Serob Karamyan

Pharmacist, Ph.D. in Pharmaceutics

Coordinates the work of the group:

1.      Expertise and Evaluation of medical devices.

Phone: (+374 60) 83-00-73,  (+374 10) 23-08-96, (+374 10) 23-16-82 + 10 05

E-mail: 

ADVISER

Albert Sahakyan

Pharmacist, Ph.D. in Pharmaceutics

Phone: (+374 60) 83-00-73, (+374 10) 23-08-96, (+374 10) 23-16-82 + 10 06

E-mail: 

DIRECTOR ASSISTANT

Anahit Aroyan

Phone: (+374 60) 83-00-73, (+374 10) 23-08-96, (+374 10) 23-16-82 + 10 00

E-mail:

IT MANAGER, NETWORK ADMINISTRATOR 

Armen Grigoryan

Phone: (+374 60) 83-00-73,  (+374 10) 23-08-96, (+374 10) 23-16-82 + 10 48

E-mail: