EIGA members are supplying medicinal gases under marketing authorizations for which pharmacovigilance activities are legally required to be performed.
This publication aims to harmonize the approach EIGA members have to these typical post-marketing cases. This is by classifying them in the same manner and therefore fulfilling the same reporting requirements to EU authorities if necessary.
The administration of medicinal gases requires the use of medical devices, and it is sometimes difficult to define incidents and differentiate between materiovigilance and pharmacovigilance. This publication also gives guidance for these typical cases, if they shall be classified as materiovigilance and/or pharmacovigilance cases.
By having harmonized practices and a consistent approach throughout industry regarding the classification and reporting of typical post-marketing cases, this will help facilitate product safety profile follow up or updates for the benefit of patients.
This edition has been revised to incorporate gas smell in reported cases in the Appendix.
This publication is intended for any personnel involved in pharmacovigilance activities within EIGA member companies.