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THE MAIN ACTIVITIES:

1. Clinical and pharmacological expertise of documents of the medicines submitted for registration in the Republic of Armenia

Clinical and pharmacological expertise of documents of medicines submitted for registration in the Republic of Armenia, in particular, review the summary product characteristics of the medicines (SmPC), patient information leaflet (PIL), reports of pre-clinical and clinical trials, comparison with international data, formulation of expert conclusion.

2. Clinical and pharmacological examination of post-registration changes

Clinical and pharmacological assessment of the presented post-registration changes, in particular - evaluation of changes in the summary product characteristics of the medicines (SmPC) and patient information leaflet (PIL), assessment of their validity and compliance with current international criteria.

3. Regulation of clinical trials in RA

Assessment of documentation submitted for obtaining permission to conduct clinical trials in Armenia and monitoring of the ongoing trials.

4. Technical editing of PIL, SmPC, primary layout and secondary packaging of medicines after registration and post-registration variations as well as their placement on the Center’s website

5. Information support and maintenance of the Center's website

6. Maintaining a database of the medicines registered in the RA

7.Scientific advicing the problems on pharmacotherapy, clinical pharmacology, rational use of drugs

HEAD OF THE DEPARTMENT:

Irina Dokhikyan

Physician

Phone: (+374 60)83-00-73, (+374 10)23-08-96, (+374 10)23-16-82+10 24

E-mail: 

LEGAL BASIS FOR ACTIVITY:

1. Republic of Armenia Law "On Medicines"

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

3. 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»

4. 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»

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 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» 

7. 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»

8. 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

9. Order of Minister of Health of the Republic of Armenia N31–N of 10 June 2019 on adopting the form of state registration certificate of medicinal products, the structure of register and operational rule of it, the rule for determining the classification of the medicinal product to the class of prescription and non-prescription medicinal products and its revision in the Republic of Armenia and on repealing the order of Minister of Health of the Republic of Armenia N123 of 7 February 2006

10. 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