Federal Register of Legislation - Australian Government

Primary content

MP1/2013 Determinations/Health as made
This instrument determines principles to be observed in the manufacture of therapeutic goods for use in humans.
Administered by: Health
Registered 28 May 2013
Tabling HistoryDate
Tabled HR30-May-2013
Tabled Senate17-Jun-2013
Date of repeal 01 Jan 2018
Repealed by Therapeutic Goods (Manufacturing Principles) Determination 2018

Text Box: Statement of Compatibility with Human Rights
Prepared in accordance with Part 3 of the Human Rights (Parliamentary Scrutiny) Act 2011

Therapeutic Goods (Manufacturing Principles) Determination No. 1 of 2013

This Legislative Instrument is compatible with the human rights and freedoms recognised or declared in the international instruments listed in section 3 of the Human Rights (Parliamentary Scrutiny) Act 2011.
Overview of the Bill/Legislative Instrument
The purpose of the Therapeutic Goods (Manufacturing Principles) Determination No. 1 of 2013 is to:

•	Make a compilation of two previous Therapeutic Goods (Manufacturing Principles) Determination: Therapeutic Goods (Manufacturing Principles) Determination No. 1 of 2007 and Therapeutic Goods (Manufacturing Principles) Determination No. 1 of 2009.

•	Update manufacturing requirements set out in the Australian Code of GMP for Human Blood and Tissues (2000), now incorporated into the Australian Code of GMP for Human Blood Components, Human Tissues and Human Cellular Therapy Products (2013).

The Therapeutic Good (Manufacturing Principles) – Determination No. 1 of 2013 specifies a number of manufacturing requirements relating to the manufacture of Therapeutic Goods that are Medicines, Blood, Blood Components, and Biologicals, Plasma, Haematopoietic Progenitor Cells and therapeutic devices. 

To ensure product safety and quality, all therapeutic goods are required to be
manufactured in a consistent and reproducible manner. This is achieved through
manufacturers complying with the relevant legislation (the Act and the Regulations) and
therapeutic manufacturing principles..

Human rights implications
This Legislative Instrument does not engage any of the applicable rights or freedoms.

Conclusion
This Legislative Instrument is compatible with human rights as it does not raise any human rights issues.

John Skerritt
Delegate of the Minister for Health