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 17025:2005 international standard in quality expertise in the field of pharmaceutical testing (Certificate number AT-2043).

 


 

 

 

DIRECTOR OF QUALITY CONTROL LABORATORY:

Aghavni Ginosyan

Pharmacist

 

ACTING DEPUTY DIRECTOR:

Anna Prazyan

Chemist, Candidate of Technical Science

Komitas 49/4, Yerevan, 0051, Republic of Armenia

Phone: Fax: (+374 10) 280733, (+374 10) 237261

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