Commonwealth Numbered Regulations - Explanatory Statements

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THERAPEUTIC GOODS AMENDMENT REGULATIONS 2000 (NO. 5) 2000 NO. 124

STATUTORY RULES 2000 No. 124

Therapeutic Goods Act 1989

Therapeutic Goods Amendment Regulations 2000 (No. 5)

The object of the Therapeutic Goods Act 1989 (the Act) is to establish and maintain a national system of controls for the quality, safety, efficacy and timely availability of therapeutic goods that are used in Australia or exported from Australia. The Therapeutic Goods Administration (the TGA) is responsible for administering the Act.

The Governor-General may, under section 63 of the Act, make regulations for the purposes of the Act. In pa~icular, the Regulations may, under subsections 34(1) and (2) of the Act, exempt therapeutic goods, or a class of therapeutic goods, or a person identified in the regulations, from the operation of Part 4 of the Act. Part 4 of the Act establishes a licensing regime for the manufacture of therapeutic goods. Under this scheme, manufacturers of therapeutic goods, unless an exemption applies under the regulations, must have a licence to engage in any step of manufacture of therapeutic goods.

The purpose of these amendments is to bring under regulation the manufacture of fresh blood and blood components. Currently the Australian Red Cross Blood Service and other blood donation centres that collect and process fresh blood and blood components are exempt from licensing requirements under Part 4 of the Act. In other countries such as the USA, Canada and the M blood components are regulated as drugs or biologics and are subject to full regulatory control. Over the last decade, technology for the manufacture of fresh blood components has become highly advanced. The collection, testing, storage, transport and processing of this class of goods involve the use of dedicated and highly specialised equipment and containers. Consultations through a working party formed by the Australian Health Nfinister's Advisory Council (AHNIAC) identified a need for a national system of regulation in Australia to cover fresh blood and blood components. There was general agreement that there is a need to ensure that national standards apply to the increasingly complex manufacturing procedures for these products.

The amending regulations seek to bring under regulation the manufacture of fresh blood and blood components by removing the current exemption applying to these products, and limiting the circumstances when an exemption may apply to emergency situations, as described in the amended Item 18 of Schedule 7 of the Therapeutic Goods Regulations.

Details of the Regulations are set out in the Attachment.

The Regulations commence on the date of gazettal.

ATTACHMENT

Therapeutic Goods Amendment Regulations 2000 (No. 5)

Regulation 1 states that the title of these regulations will be the Therapeutic Goods Amendment Regulations 2000 (No. 5)

Regulation 2 provides that these regulations will commence on 1 July 2000.

Regulation 3 provides that these regulations amend the Therapeutic Goods Regulations 1990 as provided in Schedule 1.

SCHEDULE 1 - AMENDMENTS

Item 1 updates the reference to the Red Cross, which is now known as the "Australian Red Cross Blood Service".

Item 2 substitutes the existing exemption applying to certain classes of therapeutic goods from the operation of Part 4 of the Iherapeutic Goods Act 1989. In relation to fresh blood and blood components, the exemption from the requirement to comply with Part 4 of the Act will only apply to:

-        blood and blood components collected by a medical practitioner, registered under

a law of a State or Territory, in the course of medical treatment and for the

purposes of diagnosis of, and testing for, a medical condition; or

-        blood and blood components manufactured by a medical practitioner, or by a

person under the professional supervision of that medical practitioner,

specifically for a patient under the direct care of that medical practitioner; or

-        blood and blood components manufactured by a blood donation centre for a

medical practitioner for treatment of an identifiable patient who is a patient of

that medical practitioner.

The reference to a "blood donation centre" is taken from the existing exemption applying under Item 18, Schedule 7 of the Regulations.