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Tech Alert: REMINDER pharmacovigilance - mandatory requirements and best practice expectations

12 May 2021 10:32 AM | Anonymous member (Administrator)

Today's technical alert provides a reminder on important information for sponsors in relation to mandatory pharmacovigilance requirements and best practice TGA expectations. This technical alert was originally sent to members in November 2020 with a member alert, as well as a public link that can be accessed by non-members, describing the mandatory requirements.

Included in both the public and member only alert is a reminder that notifying the TGA of a sponsor's pharmacovigilance contact person is a mandatory requirement under the Therapeutic goods Act 1989 please ensure that your company has an up-to-date pharmacovigilance contact person provided to the TGA and other mandatory requirements are met as outlined in this alert and on the TGA website.

The member only alert, available here via member login, includes all of the information contained in the public alert below, in addition to other information tailored specifically to help members reduce regulatory burden and other member only information.

The public alert is available for open distribution to all members of industry to ensure that all have access to timely reminders for minimum compliance requirements which help to uphold industry safety and quality. This public link can be shared.

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