Although the legislative framework for pharmacovigilance has not changed significantly in the last two years, there are still many companies, especially smaller organizations, which appear to struggle to meet these requirements.

All companies have a statutory obligation to seek information about potential problems in the use of their medicinal products - it is not an option.

It is vital that all companies with EU marketing authorizations have mechanisms in place for obtaining, recording, storing, and submitting suspected adverse drug reactions to the regulatory authorities in the countries in which the authorizations are valid. This requirement applies to both national authorizations obtained through the mutual recognition procedure and EU-wide authorizations obtained through the centralized procedure.