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MP1/2009 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 29 Jul 2009
Tabling HistoryDate
Tabled HR11-Aug-2009
Tabled Senate11-Aug-2009
Date of repeal 31 May 2013
Repealed by Therapeutic Goods (Manufacturing Principles) Determination No. 1 of 2013

 

 

Therapeutic Goods Act 1989

 

Therapeutic Goods (Manufacturing Principles) Determination No. 1 of 2009

MP1/2009

 

I, ROHAN HAMMETT, delegate of the Minister for Health and Ageing for the purpose of section 36 of the Therapeutic Goods Act 1989 and acting under subsection 36(1) of that Act, determine the following principles to be observed in the manufacture of therapeutic goods for use in humans.

 

Dated       21       July  2009

 

 

Signed

 

(signed by)

ROHAN HAMMETT

Delegate of the Minister for Health and Ageing

 

 

 

1.     Citation

This Determination may be cited as the Therapeutic Goods (Manufacturing Principles) Determination No 1 of 2009.

2.     Commencement

This Determination commences on the day after it is registered in the Federal Register of Legislative Instruments.

[Note: see Legislative Instruments Act 2003 section 12.]

3.     Amendment and revocation

(1) The amendments set out under subsection (2) and the revocation set out under subsection (3) will commence to operate on and from 1 July 2010.

(2) The Therapeutic Goods (Manufacturing Principles) Determination No.1 of 2007 is amended by:

(i)          deleting paragraph 4(a), Sections 6 and 7 including the heading “Division 1 – Manufacturing principles for all medicines” and paragraph 13(b);

(ii)        deleting the following definitions under the heading “Interpretation”:

(a)     “active pharmaceutical ingredients”;

(b)    “medicine”;

(c)     “Sunscreen Code of GMP”;

(d)    “sunscreen products”; and

(e)     “the Code”;

(iii)       at paragraph 4(c), deleting the words “Other therapeutic goods not covered by Divisions 1 to 2” and  replacing these words with  “Therapeutic devices and sunscreen products”;

(iv)      at the heading to Division 3, deleting the words “other products not covered by Divisions 1 and 2” and replacing these words with “therapeutic devices and sunscreen products”;

(v)        at paragraph 13, deleting the word “goods” in the first line of that paragraph and replacing that word with “therapeutic devices and sunscreen products ”; and

(vi)      renumbering paragraphs 4(b) and (c), as 4(a) and 4(b), and renumbering paragraphs 8 – 13, as 6 – 10.

(3)   The Therapeutic Goods (Manufacturing Principles) Determination No.1 of 2002 is revoked.

 

4.     Interpretation

 In this Determination, unless the contrary intention appears:

active pharmaceutical ingredients (API) means any substance or mixture of substances intended to be used in the manufacture of a drug (medicinal) product and that, when used in the production of a drug, becomes an active ingredient of the drug product. These substances are intended to furnish pharmacological activity or other direct effect in the diagnosis, cure, mitigation, treatment, or prevention of disease or to affect the structure and function of the body;

blood means whole blood extracted from human donors;

blood components means therapeutic components that have been manufactured from blood including red cells, white cells, platelets and plasma, except for products produced through fractionation of plasma;

haematopoietic progenitor cells means primitive pluripotent haematopoietic progenitor cells capable of self-renewal as well as maturation into any of the haematopoietic lineages, including committed and lineage-restricted progenitor cells

plasma means plasma, separated from human donor blood, intended for a number of purposes including the production of further blood components required to be licensed under Chapter 3, Part 3-3 of the Act;

sunscreen products means the goods mentioned in Item 7, Part 1 of Schedule 4 to the Therapeutic Goods Regulations 1990;

the Act means the Therapeutic Goods Act 1989;

the Code means the document titled “Guide to Good Manufacturing Practice for Medicinal Products”, PE 009-8, published by the Pharmaceutical Inspection Convention and Pharmaceutical Inspection Co-operation Scheme (jointly referred to as PIC/S), dated 15 January 2009, except for the following Annexes of that document:

(a)   Annex 4 (titled Manufacture of Veterinary Medicinal Products Other Than Immunologicals); and

(b)   Annex 5 (titled Manufacture of Immunological Veterinary Medicinal Products); and

(c)   Annex 14 (titled Manufacture of Products Derived From Human Blood or Human Plasma) of that document;

TGA means the Therapeutic Goods Administration, a division of the Department of Health and Ageing.

5      Manufacturing principles for therapeutic goods

(1)     This section applies to therapeutic goods, other than:

(a)   blood, blood components, plasma and haematopoietic progenitor cells; and

(b)   human tissue; and

(c)   therapeutic devices.

Note –    The Australian Code of GMP for Therapeutic Goods – Sunscreen Products, February 1994 will no longer be applicable from 1 July 2010.

(2)     Subject to section 6, therapeutic goods must be manufactured in compliance with the Code. 

(3)     Subject to subsection (5), manufacturers of therapeutic goods in Australia must follow the procedures and requirements set out in Part One of the Code, and in addition, each of the Annexes to the Code that apply to the particular therapeutic goods being manufactured. 

(4)     Subject to subsection (5), where the Code provides that a procedure or requirement ‘should’ be followed, manufacturers of therapeutic goods in Australia must follow that procedure or requirement in order to comply with the Code.

(5)     The failure of a manufacturer of therapeutic goods in Australia to follow a particular procedure or requirement set out in an applicable Part of, or Annex to, the Code, constitutes a failure to comply with the Code, unless in relation to that particular procedure or requirement:

(a)   the manufacturer demonstrates, to the satisfaction of the TGA, that the failure to adopt that procedure or requirement:

                                                                   (i)      will not increase the risk of harm or injury to any person or will not potentially have the effect of causing or contributing to such harm; and

                                                                 (ii)      will not increase the risk of the therapeutic goods in question failing to comply with, where applicable, both the standard for that therapeutic goods and to the terms of the listing or registration; and

                                                                (iii)      will not compromise the record keeping requirements contained in the Code; or

(b)   where an alternative procedure to the procedure or requirement set out under an applicable Part of, or Annex to, the Code has been adopted, the manufacturer demonstrates, to the satisfaction of the TGA, that:

                                                                   (i)      the alternative procedure will not increase the risk of harm or injury to any person or will not potentially have the effect of causing or contributing to such harm; and

                                                                 (ii)      the alternative procedure will not increase the risk of the therapeutic goods in question failing to comply with, where applicable, both the standard for that therapeutic goods and the terms of the listing or registration; and

                                                                (iii)      will not compromise the record keeping requirements contained in the Code.

(6)     For the purposes of subsection 5(3), the word “apply” does not include the application, to particular therapeutic goods being manufactured, of an Annex that is stated in the Code to be ‘voluntary’.

 

6. Transitional Provisions

(1)     From the commencement date of this Determination up to and including 30 June 2010, the manufacture of therapeutic goods to which subsection 5(1) applies, other than active pharmaceutical ingredients, must comply with the requirements of either:

(a)   section 5 of this Determination; or

(b)   the Therapeutic Goods (Manufacturing Principles) Determination No.1 of 2007.

(2)     From the commencement of this Determination and up to and including 30 June 2010, the manufacture of active pharmaceutical ingredients must comply with the requirements of either:

(a)   section 5 of this Determination; or

(b)   the Therapeutic Goods (Manufacturing Principles) Determination No.1 of      2002.

 

 

Note –    The manufacturing principles applicable to blood, blood components, plasma, haematopoietic progenitor cells, human tissue and therapeutic devices have not changed.