Underpinned by the Medicines Act in Armenia, those involved in medicines and medical devices are expected to take a professional and proactive approach to pharmacovigilance.
The Scientific Centre of Drug and Medical Technology Expertise (SCDMTE), within the Ministry of Health, has responsibility for pharmacovigilance. Its two key roles in this respect relate to: monitoring drug safety and the analysis of all adverse reactions reported to the department. Beyond this, the department is involved in PSUR (Periodic Safety Update Reports), RMP and DHPL, the publication of pharmacovigilance training materials, the publication of a drug safety bulletin and the administration of a patient hotline.
Any marketing authorization holder (MAH) must set up a system through which they are able to continuously monitor the safety of their products and report, when necessary, to the pharmacovigilance department at the SCDMTE.
With Armenia a member of the Eurasian Economic Union, there is an expectation too, that the MAH will appoint a local qualified person responsible for pharmacovigilance (QPPV) who will be based in the country.
With a comprehensive understanding of local pharmacovigilance procedures Grove provides a range of pharmacovigilance services in Armenia within a fully comprehensive outsourced local pharmacovigilance solution.
For those involved in medicines and medical devices, the pharmacovigilance service package comprises: