Electronic signatures to replace 'wet ink' signatures

5 July 2017

All Licences and Certificates of GMP Compliance issued by the TGA will be signed "electronically" and no longer contain a wet ink signature.

Background

The removal of the TGA's exemption from the Electronic Transactions ACT 1999 in 2015, for the Therapeutic Goods Act 1989 and the Therapeutic Goods Regulations 1990, provided the TGA with an opportunity to review current practices and align with the Electronic Transactions ACT 1999.

As part of this review it was identified that there is no legislative requirement for Licences or Certificates to contain a 'wet-ink' signature, so this is an opportunity to align with the TGA's other documents that are already issued with electronic signatures (e.g. decision letters, Conformity Assessment certificates, Certificates of Analysis). Additionally, this initiative will position industry for a future move to online self-service.

What will I notice?

There will no longer be a signature block on the Licence or Certificate. The covering decision letter will have a signature block that will only display the name of the Delegate or Authorising Officer.

All Licences, Certificates and covering decision letters will be issued as portable document format (.pdf) files by email only. Hard copies of Licences, Certificates and covering decision letters will no longer be issued.

As such, it is important to ensure that your email addresses are up to date.

What is not changing?

The Licence and Conditions will still be displayed at the manufacturing premises. (r.20(a) of the Therapeutic Goods Regulations 1990).

Australian manufacturers licensed with the TGA will still be listed on our public website, https://www.ebs.tga.gov.au/.

Notarised copies of Licences and Certificates will contain a wet ink signature of the notary.