THE MAIN ACTIVITIES:

1. Monitoring of adverse drug reactions (ADR) including collection, evaluation and management of ADR data.

2. Monitoring of other medicine-related safety issues including collection, evaluation and management of information related to quality, lack of efficacy, and counterfeiting of medicines.

3. Maintaining  the national database of adverse drug reactions

4. Expertise of risk management plan (RMP) and managing the risk minimization measures.

5. Expertise and confirmation of publishing information related to safety of medicines.

6. Expertise of periodic safety update reports (PSUR)

7. Signal detection and management

8. Expertise of post-registration safety variations.

9. Provision of safety report for regulatory decisions

10.  Provision of  safety communication

11.  Development of educational and training materials to raise awareness on medicine safety

12. Publishing “Safety of medicines” bulletin

13.  Screening of literature and other sources on medicine safety

14. Accepting public inquiries on ADRs and medicine-related other safety issues and providing feedbacks by  hot-line route

HEAD OF THE DEPARTMENT:

Narine Hovhannisyan

Physician

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

Hot Line: (+374 10) 20-05-05, (+374 96) 22-05-05

E-mail: narineh@pharm.am; vigilance@pharm.am

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. Order of the Ministry of Health of the Republic of Armenia N23-N of May 17 2017 on approving “The order of recording and reporting cases of adverse reactions, lack of effectiveness, misuse and suspect on falsification of medicines; collecting, reporting, monitoring, submitting reports and analyzing data on adverse reactions of medicines, approving the form of the register of adverse reaction and form of reporting of adverse reactions, lack of effectiveness, misuse and suspect on falsification of medicines

6. 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

DRUG SAFETY MONITORING

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Published: 06 November 2014

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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

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Published: 06 November 2014

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THE MAIN ACTIVITIES:

1. Monitoring of the activity of pharmacies and wholesalears,

2. Specialized expertise held on the production process of the local pharmaceutical manufactures.

HEAD OF THE DEPARTMENT:

Mkrtich Shakaryan

Pharmacist

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 licensing"

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 867 of June 29, 2002

5. Order of the Minister of Health of the Republic of Armenia N 03-A of March 4, 2008 on adopting sanitary rules and norms N 2.1.3-3 «Hygienic and antiepidemic demands to the usage of medical wastes in RA»

6. Decree of the Government of the Republic of Armenia N 199-N of February 28, 2019 «Օn adopting the rules of compliance inspection with the requirements of Good Manufacturing Practice of medicinal products and pharmaceutical substance, the issuance of the Good Manufacturing Practice Certificate, as well as the assessment rule for the purpose of licensing the manufacturing of medicinal products and the list of necessary documents; and on repeal of the Decree of the Government of the Republic of Armenia N 1603-N of November 25, 2010 and the Decree of the Government of the Republic of Armenia N 1089-N of September 23, 2013»

7. Decree of the Government of the Republic of Armenia N 156-N of February 28, 2019 «Օn adopting the rules of inspection in the scope of distributor certification and issuance a Good Distribution Practice certificate, the assessment rule for the purpose of licensing the medicinal products wholesale realization and the list of necessary documents in the Republic of Armenia»

8. Decree of the Government of the Republic of Armenia №734-N of 28 May, 2011 on approving implementation schedule of the rules of Good Manufacturing Practices (GMP) and realization of reforms in medicines circulation in the Republic of Armenia

9. Order of the Minister of Health of the Republic of Armenia N1325-A of July 8, 2011, «On adopting the list of necessary legal acts and program of implementation of the Quality management system required for the activity of the GMP/GDP inspection department

10. Decree of the Government of the Republic of Armenia N 164-N of February 28, 2019 «Օn adopting the procedures in the Republic of Armenia related to rapid alert, termination of circulation and recall of nonregistered, non-conforming quality requirements, expired, registration withdrawal or suspended medicinal products, counterfeit medicinal products, active substance, herbal substances, investigational medicinal products and medicinal products imported in violation of the legislation of the Republic of Armenia»

11. Convention on collaboration in the struggling against the counterfeit medicinal products circulation

12.  Decree of the Government of the Republic of Armenia N 724-N of July 4, 2013, «On adopting the check lists of risk based inspection on assuring mandatory requirements of importers, exporters and entities carrying out pharmaceutical activity»

13. Order of the Minister of Health of the Republic of Armenia N 05-N of February 1, 2013, «On adopting the rules of medical waste management in pharmacies and pharmaceutical outlets»

14. Order of the Minister of Health of the Republic of Armenia N 189-A of February 06, 2014, «On adopting the GMP compliance inspection fee»

15. Order of the Minister of Health of the Republic of Armenia 1324-A, July 8, 2011

16. Order of the Minister of Health of the Republic of Armenia 1395-A, June 15, 2012

17. Order of the Minister of Health of the Republic of Armenia 1396-A, June 15, 2012

18. Order of the Minister of Health of the Republic of Armenia 1613-A, July 8, 2014

19.  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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Published: 06 November 2014

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