Therapeutic Goods (Manufacturing Principles) Amendment Determination 2017 (No. 1) (Cth)

Therapeutic Goods Act 1989

Therapeutic Goods (Manufacturing Principles)

Amendment Determination 2017 (No.1)

I, LARRY KELLY, a delegate of the Minister for Health, make this Determination under subsection 36(1) of the Therapeutic Goods Act 1989.

Dated this 2^nd day of May 2017.

(Signed by)

LARRY KELLY

Delegate of the Minister for Health

1. Name of Determination

This Determination is the Therapeutic Goods (Manufacturing Principles) Amendment Determination 2017 (No.1).

2        Commencement

This Determination commences on the day after it is registered.

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

The Therapeutic Goods (Manufacturing Principles) Determination No.1 of 2013 is amended as set out in Schedule 1.

Schedule 1            Amendments

(section 3)

[1]     Section 3, Application 

Insert “(except things that comprise or contain live animal cells, tissues or organs)” after the word “Biologicals”, twice occurring in 3.a and 3.b respectively.

Add, after “c. Division 3 – Therapeutic Devices”:

“Note: The manufacturing principles applicable to therapeutic goods that are things that comprise or contain live animal cells, tissues or organs are those set out in Division 1, and not those set out in Division 2”.

[2]     Division 1, Heading

Insert “(except things that comprise or contain live animal cells, tissues or organs)” after the word “Biologicals”.

Add, under the heading:

“Note: The manufacturing principles applicable to therapeutic goods that are things that comprise or contain live animal cells, tissues or organs are those set out in Division 1, and not those set out in Division 2”.

[3]     Division 1, subclause (1), paragraph (b)

Insert “(except things that comprise or contain live animal cells, tissues or organs)” after the word “biologicals”.

[4]     Division 1, subclause (2)

Repeal the subclause, substitute:

“(2)      Subject to subclause (3), manufacturers of therapeutic goods in Australia to which this Division applies must follow the procedures and requirements set out in the Part of the Code, and the Annex to the Code that applies to the particular goods being manufactured.”

[5]     Division 2, Heading

Insert “(except things that comprise or contain live animal cells, tissues or organs),” after the word “Biologicals”.

[6]     Division 2, subclause (5)

Insert “(except things that comprise or contain live animal cells, tissues or organs),” after the word “biologicals”.

[7]     Division 2, subclause (8)

Insert “(except things that comprise or contain live animal cells, tissues or organs),” after the word “Biologicals”.