EIGA Document 203/16 – Typical Post-Marketing Pharmacovigilance Cases in the Medical Gases Industry
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 publication is intended for any personnel involved in pharmacovigilance activities within EIGA member companies.
This publication can be viewed or downloaded on the EIGA Website by clicking here. You can view or download many other EIGA publications at the following address: www.eiga.eu.
12 September 2016