Electronic signatures to replace 'wet ink' signatures

24 August 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

In 2015 the TGA commenced activity to remove the exemption to the Electronic Transactions ACT 1999 from the Therapeutic Goods Act 1989 and Therapeutic Goods Regulations 1990.

In 2016, a TGA wide procedure was issued to standardise arrangements for the electronic signing and transmission of decision letters issued under TGA's legislation. The manufacturing branch in TGA then undertook a review of signing arrangements for Licenses, Certificates and decision letters. As part of this review it was identified that there is no legislative requirement for Licences or Certificates to contain a 'wet-ink' signature. This represented 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).

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.