THE MAIN ACTIVITIES:

1. Monitoring safety of drugs in RA,

2. Detection, assessment, understanding  of ADR reports,

3. Expertise of documents related to safety of drugs such as:

  • PSUR,

  • RMP,

  • DHPL,

4.  Publishing  “Drug safety” bulletin,

5. Development of educational and training materials on medicine safety,

6. Accepting patient’s inquiries and providing feedbacks on drug safety by using hot line calls.

 

HEAD OF THE DEPARTMENT:

Naira Romanova

Pharmacist

Phone: (+374 10) 231682, 230896, 234732, 232091, 123

Hot Line: (+374 10) 237265, (+374 98) 773368

E-mail: ,

 

LEGAL BASIS FOR ACTIVITY:

  1. Republic of Armenia Law "On Medicines"

  2. Order оf the MoH оf the RA N123-N of 07.02.2006, on approving «The order of conducting expert examination of medicines with purpose of state registration in the RA, the table of minimum quantity of submitted samples of medicines attached with application, the conclusion form of the examination of а medicine with the purpose of registration, the form and description of the state registration certificate, the list of changes of medicines registered in the Republic of Armenia that do not require new registration”.

  3. Decree of the Government of the Republic of Armenia N 347 of April 25, 2001

  4. Order of the Ministry of Health of the Republic of Armenia N20-N of May 15, 2015 on approving "Drugs unknown adverse reactions report form"

  5. Order of the Ministry of Health of the Republic of Armenia N1464-A of May 04 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

 

DRUG SAFETY PROFILE