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:

Naira Romanova

Pharmacist

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: ,

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. Pharmacovigilance Guideline

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

DRUG SAFETY MONITORING