The terms of validity of registrations of medicine products registered under the national procedure

Dear colleagues, We would like to inform you that on June 24, 2025, the Minister of Health of the Republic of...


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Changes to Decision N78 dated November 3, 2016 On the rules for the registration and assessment of medicinal products for medical use

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Order N3273-A of May 30, 2025 on acceptance of applications for state registration of medicines for human use in accordance with the temporary rule in Republic of Armenia and on...

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Essential Medicines List 2025

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Decision EAEU N88 of November 03, 2016 on the Adoption of the Requirements for the Medication Guide and Summary of Product Characteristics of medicinal products for human use

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Decision of EAEU N78 of November 03, 2016 on the rules of medicines registration and assessments

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Information about making changes and additions in Decree of the Government of the Republic of Armenia N162-N of February 28, 2019

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Information regarding Order N312-N on approval of the rules of the Good Pharmacovigilance Practice in Republic of Armenia

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Information about temporary rule of acceptance of applications for state registration of medicines by national procedure

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Notification of a technical problem to INFO@ampra.am

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PLAN of inspections in compliance with the guideline of Good Manufacturing Practice of Eurasian Economic Union rules

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Information about changes in the activities of “Center of Drug and Medical Technology Expertise” SNPO

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List of documents required for determining the regulatory status of borderline products

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Information about medicines registration

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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

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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