States and Territories are developing complementary legislation in relation to the Commonwealth Therapeutic Goods Act 1989 to provide for a uniform national system of controls on therapeutic goods.

The Therapeutic Goods (Victoria) Act 1994 received Royal Assent on 22 November 1994. The legislation comes into force six months after this date - ie. 23 May 1995.

Other States and Territories will be progressively introducing complementary legislation in their jurisdictions.

The immediate effect of the commencement of the Therapeutic Goods (Victoria) Act 1994 is to bring all therapeutic goods, which are supplied in Victoria only by sole traders and partnerships, into the national scheme for therapeutic goods. The national scheme aims to ensure the quality, safety, efficacy and timely availability of therapeutic goods for human use, and to set standards for the quality of therapeutic goods used for animals.

The major features of the scheme are:

• Unless exempt, therapeutic goods for human use that are manufactured and supplied within Victoria must be included in the Australian Register of Therapeutic Goods (ARTG);
• Unless exempt, Victorian manufacturers of therapeutic goods for human use must be licensed and comply with principles of good manufacturing practice (GMP); and
• Therapeutic goods supplied for use in humans and animals must comply with relevant standards, including labelling.

The date of effect of Commonwealth controls, via the Victorian complementary legislation, is 23 May 1995. After this date, persons affected will have three months to lodge applications for "grandfather" registration or listing of therapeutic goods currently being supplied, and four months to apply for a licence to manufacture therapeutic goods.

Who does the Therapeutic Goods (Victoria) Act 1994 affect?

All person/s supplying or manufacturing therapeutic goods (drugs and medical devices) for human use as sole traders, partnerships or other unincorporated entities trading solely in Victoria prior to the commencement of the Act.

What is expected from persons affected?

Are there any fees payable for an application?

No application fee is payable for entry of these goods in the ARTG under the transitional arrangements of the Victorian Act. An annual fee will be payable for each entry in the ARTG, as well as any other associated fees.

What happens if I don't apply to TGA in this period?

If an application for "grandfathering" of a good supplied prior to the commencement of the Victorian Act is not received within the specified time, or if the goods are first supplied after the commencement date, a normal registration or listing application must be made to the appropriate TGA evaluation or reviewing area. An application fee is payable for these applications.

What documentation do I need?

Forms, guidelines and other documentation to assist in the submission of a drug application can be obtained from the TGA.

What is the outcome of an application?

A Certificate of Listing or Registration will be issued after reviewing all information supplied to the TGA. This will require the sponsor to include the AUST L or AUST R number/s on the main label of the primary pack within three months of receipt of their number/s. Initially, it will be acceptable to apply the number by means of an oversticker until the artwork is completed.

Further information

The Department of Health and Community Services Victoria has a fact sheet concerning the Therapeutic Goods (Victoria) Act 1994 which provides information about the types of goods covered by the Act, GMP arrangements and timeframes for making applications.