Technical Alerts

The CHC is seeking comment and input on the TGA consultation for a proposal for automatic adoption of new
versions of the PIC/S Guide to Good Manufacturing Practice for Medicinal Products.

Submissions are welcome to the CHC by COB Friday, 2 August 2013 for submission to the TGA by the 12
 August 2013.

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The CHC invites you to comment on the TGA’s Office of Manufacturing Quality - Draft Release for Supply
Technical Guidance document Part 1 General Guidance and Responsibilities.

Submissions are welcome to the CHC by COB Friday, 23 August for submission to the TGA by the
6 September 2013.

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The CHC is seeking comment and input on the TGA Consultation regulatory impact statement (Consultation RIS) for regulating the advertising of therapeutic goods to the general public. Submissions are welcome to the CHC before Friday, 28 June 2013 for submission to the TGA by the 12 July 2013.

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The end of financial year is an important time to consider the financial aspects of your entries in the
Australian Register of Therapeutic Goods. Annual charges for 2013-14 for entries in the Register will be
generated in July 2013. All entries in the Register as at 1 July are subject to the full year’s annual charge.

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The CHC invites nominations from experienced ELF users to attend a session to assist in the final test cycle of the new Electronic Listing Facility (ELF). The session will be conducted at the Symonston TGA on Tuesday 18 June from 10:00am-12:00pm.

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The CHC is seeking comment and input from stakeholders on the draft document ARGCM Part C: Evaluation of complementary medicine substances for use in listed medicines.

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The Therapeutic Goods Amendments (2013 Measures No. 1) Bill 2013 makes a number of amendments to
the Therapeutic Goods Act 1989 (the Act), and has been introduced to Parliament for a second reading.
The CHC has been invited by the Community Affairs Legislation Committee to make a submission outlining the
impacts of this Bill on industry.

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The TGA has informed the CHC of a revised process for ACCM meeting minutes that aims to bring about greater
consistency and clarity to the roles of TGA statutory advisory committees.

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The CHC is seeking comment and input from stakeholders in relation to a proposed revision of the draft compositional guideline for Trefriw Wells mineral water and draft compositional guideline for Calcified Lithothamnion tophiforme (AAN).