Therapeutic Goods (Manufacturing Principles) Determination No. 2 of 2002 (Cth)

COMMONWEALTH OF AUSTRALIA

Therapeutic Goods Act 1989

Therapeutic Goods (Manufacturing Principles)

Determination No 2 of 2002

MP2/2002

I, TERRY SLATER, delegate of the Parliamentary Secretary to the Minister for Health and Ageing for the purposes of section 36 of the Therapeutic Goods Act 1989 and acting under subsection 36(1) of that Act:

1. AMEND the Therapeutic Goods (Manufacturing Principles) Determination No.1 of 1999 by deleting, from Clause 4 of that Determination, the references to:

(a)     the “Australian Code of Good Manufacturing Practice for Therapeutic Goods – Medicinal Products (August 1990); and

(b)     the Australian Code of Good Manufacturing Practice for Therapeutic Goods – Medicinal Gases (July 1992); and

(c)     the Investigational Medicinal Products Code of GMP; and

1. DETERMINE the following principles, as set out below, to be observed in the manufacture of medicines described in Clause 5 of this Determination.

Dated this 20th day of August 2002

Terry Slater

Delegate of the Parliamentary Secretary to the Minister for Health and Ageing

Citation

1. This Determination may be cited as the Therapeutic Goods (Manufacturing Principles) Determination No 2 of 2002.

Commencement

1. Clause 1 commences twelve months from the date of this Determination is gazetted in the Commonwealth Gazette; and

Clause 2 of this Determination commences on the date it is gazetted in the Commonwealth Gazette.

[Note:  See Acts Interpretation Act 1901, ss.46A and 48]

Application of Determination

5.       This Determination applies to the manufacture of all medicines, except:

(a)medicines that are exempted from the requirement to comply with Part 4 of the Therapeutic Goods Act 1989 and

(b)sunscreens products; and

(c)blood, blood components and plasma; and

(d)human tissue.

Interpretation

1. In this Determination, unless the contrary intention appears:

(a)“the Code” means the document entitled “Australian Code of Good Manufacturing Practice For Medicinal Products” dated 16 August 2002, the availability of which was gazetted on 21 August 2002 in the Commonwealth Gazette;

(b)“medicine” has the same meaning as “medicine” in subsection 3(1) of the Therapeutic Goods Act 1989.

(c)in this Determination, words in the singular number include the plural and words in the plural number include the singular.

Compliance with the Guide in the Manufacture of Medicines

1. Subject to Clause 8 of this Determination, medicines to which this Determination applies must be manufactured in compliance with the Code.

1. For the first twelve months after the date this Determination is gazetted, the manufacture of medicines to which this Determination applies must comply either with:

(a)       each of the manufacturing standards listed in Clause 1 of this Determination, as applicable to the medicine being manufactured; or

(b)      the Code.