pharmacovigilance
A local Qualified Person for Pharmacovigilance (QPPV), implementation of a pharmacovigilance (PV) system, and full compliance with Ukrainian Ministry of Health regulatory requirements. For foreign manufacturers and local marketing authorisation holders.
the challenge
Every marketing authorisation holder is required to establish, maintain and guarantee a functioning pharmacovigilance system in line with Ukrainian Ministry of Health requirements and international GVP standards. Without a proper PV system, a manufacturer risks temporary suspension of the product's registration, revocation of the marketing authorisation, and legal liability.
Most Common Problems
our solution
We Take On All Pharmacovigilance Obligations
Amicum Pharma provides local QPPV services, designs and implements PV systems, collects and processes adverse reaction reports, and prepares all required reporting. You meet your regulatory obligations without maintaining an in‑house pharmacovigilance department.
«No adverse reaction report ever goes unnoticed»
What's Included in the Service
A full range of pharmacovigilance services for foreign manufacturers and local marketing authorisation holders.
Foreign Manufacturers
International pharmaceutical companies that hold, or plan to obtain, a marketing authorisation in Ukraine and are required to appoint a local QPPV.
Appointment and functions of the local QPPV
Implementation of a GVP‑compliant PV system
Representation before the Ukrainian Ministry of Health
Local Marketing Authorisation Holders
Ukrainian companies that hold marketing authorisations and are required to maintain a pharmacovigilance system in accordance with national legislation.
Audit and update of the existing PV system
Preparation and submission of mandatory reporting
Pharmacovigilance staff training
Amicum Pharma Partners
Manufacturers already working with Amicum on distribution or registration. Pharmacovigilance as part of a comprehensive partnership.
Pharmacovigilance as part of the full cycle
A single point of contact for all regulatory matters
Transparent reporting under the partnership agreement