The pharmacovigilance system consists of elements that make it possible to monitor the safety of medicinal products, vaccines and tuberculin and to identify any changes in the benefit/risk balance, namely:
- the presence of a QPPV at the applicant. If the applicant is located in Ukraine, the QPPV must be on the applicant's staff. If the applicant is located outside Ukraine, a single LCPPV in Ukraine, subordinate to the applicant's QPPV, must be designated on the territory of Ukraine. Data on the QPPV and LCPPV in Ukraine must be contained in the applicant's PSMF. The QPPV/LCPPV in Ukraine must have a higher medical or pharmaceutical education (pharmacist, clinical pharmacist). If the person has only a higher pharmaceutical education, the QPPV/LCPPV in Ukraine must be able to consult a person with a higher medical education (if necessary). Each pharmacovigilance system may have only one QPPV/LCPPV in Ukraine. A procedure for substituting the QPPV and/or LCPPV in case of their absence must be provided;
- availability of a structured system for organizing pharmacovigilance, and its updating and maintenance;
- documenting all procedural processes;
- creation and maintenance of the databases used by the applicant in carrying out pharmacovigilance;
- engaging (if necessary) other legal entities and/or individuals, enterprises, institutions and organizations in pharmacovigilance by concluding contractual relations;
- ensuring training of the applicant's staff to perform pharmacovigilance-related activities;
- establishing a pharmacovigilance quality system;
- maintaining pharmacovigilance documentation, including its storage and archiving;
- establishing and maintaining a risk management system.
Clause 2 of Chapter 1 of Section V of the Procedure for Pharmacovigilance.
