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.
LOCAL PV EXPERTISE IS VITAL FOR PHARMACOVIGILANCE SERVICES
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.
Regulatory consulting – regulatory submissions and registration related services
Preparation and submission of relevant documentation for drug registration and marketing authorization
Medical device registration
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.
A FULLY COMPREHENSIVE SOLUTION FOR PHARMACOVIGILANCE SERVICES
Grove offers a fully comprehensive outsourced solution for local pharmacovigilance activities for clients unable or unwilling to invest in the development of relevant systems on their own account.
With proven success over two decades, Grove has developed a comprehensive package which meets the needs of both its individual clients and the relevant local authorities. The service is continually developed to ensure it remains relevant and is bespoke to the client in question.
For those involved in medicines and medical devices, the pharmacovigilance service package comprises:
- Full-time (24/7) service of a local qualified pharmacovigilance person, QPPV
- 24-hour cover for adverse event reporting
- In-time case reporting
- End-to-end processing of safety information
- Production of PSUR (periodic safety update reports)
- Production of individual case study reports
- Access, as and when appropriate, to local healthcare professionals and authorities
- MLM (Medical Literature Monitoring) services
- System quality control checks to ensure full audit compliance