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Public access to information contained in ARTG entries for therapeutic goods
The consultation period for this document closed on 3 February 2006.
The purpose of this Discussion Paper is to provide a basis for discussions with stakeholders regarding the proposal to publicly release therapeutic goods information in respect of Australian Register of Therapeutic Goods (ARTG) entries, including via the internet.
The Australian community expects that medicines and medical devices in the marketplace are safe and of high quality, and of a standard at least equal to that of comparable countries. The objective of the Therapeutic Goods Act 1989 (the Act) which came into effect on 15 February 1991, is to provide a national framework for the regulation of therapeutic goods in Australia to ensure the quality, safety and efficacy of medicines and ensure the quality, safety and performance of medical devices.
The regulatory framework is based on a risk management approach designed to ensure public health and safety, while at the same time freeing industry from any unnecessary regulatory burden.
Essentially, therapeutic goods must be entered on the ARTG before they can be supplied in Australia. The ARTG is a computer database of information about therapeutic goods for human use approved for supply in, or exported from, Australia.
The Act, Regulations and Orders set out the requirements for inclusion of therapeutic goods in the ARTG, including advertising, labeling, product appearance and appeal guidelines. Some provisions such as the scheduling of substances and the safe storage of therapeutic goods are covered by the relevant State or Territory legislation.
The Therapeutic Goods Administration (TGA) is a unit of the Australian Government Department of Health and Ageing and is responsible for administering the provisions of the legislation.
The TGA carries out a range of assessment and monitoring activities to ensure therapeutic goods available in Australia are of an acceptable standard. At the same time the TGA aims to ensure that the Australian community has access, within a reasonable time, to therapeutic advances.
Information on therapeutic goods is held on the ARTG database and also in hard copy form. There were approximately 63,800 products on the ARTG as at 30 September 2005. Information held on the database includes product names, formulation details, and sponsor and manufacturer details.
Under the current Act and associated Therapeutic Goods Regulations 1990 (the Regulations) the TGA is limited in the range of information that it can publicly release and to whom. Specifically, the Regulations as they are currently worded, permit the release of certain information only if it is specified in the Regulations and then only if a person applies for the release of such information.
The TGA is proposing to extend the range of information generally available to consumers on the public access part of the ARTG to include all the details currently listed in regulation 46(2). A copy of regulation 46(2) in its current form is at Attachment 1. It is also proposed to include some additional items in regulation 46(2) which are not currently specified such as the ARTG label name, product and component ID (these are computer generated numbers that assist in presentation of the information), product type and pack size, shelf-life information, visual identification information and any product warnings.
The proposed amendments will provide an easily accessible 'one stop' central repository of information that is currently available from a variety of different and separate sources including product labels, Consumer Medicines Information (CMI) and Product Information (PI) documents. It will enable health professionals, consumers and other stakeholders to be better informed about the therapeutic products available in Australia, thereby contributing to increased transparency of the regulatory system.
Information that is genuinely commercially sensitive, such as product formulation details, will continue to be protected.
Requirements to effect the changes
The proposed changes would require an amendment to regulation 46(2) to enable the proposed range of information to be released, including via the internet, without a specific application having to be made.
Through the consultation process the TGA hopes to receive feedback on the viability of publicly releasing therapeutic goods information in respect of ARTG entries.
This consultation closed on Friday 3 February 2006.
Any future action by the TGA on this proposal will be determined following the consideration of all the issues raised through the consultation process.
Regulation 46(2) - Release of Information
(2) ........., the Secretary may release to a person, on application by that person, therapeutic goods information in respect of an entry in the Register, being therapeutic goods information of the following kinds:
- whether the goods are included in the ARTG and if so:
- the registration number, listing number or device number of the goods;
- the date when the goods were registered, listed or included in the ARTG; and
- the class in which the goods are included in the ARTG;
- the name of the goods and the name and address of the sponsor of the goods
- if any ingredient in, or component of, the goods is derived from an animal, the type of animal;
- if the goods are supplied in a sterile state, the type of sterilisation used;
- if the goods are medicines, medical devices that contain medicines, or medical devices that incorporate, or are intended to incorporate, as an integral part, a medicine that is intended to act on a patient in a way that is ancillary to the device:
- the quantity of the goods to be in the primary pack;
- the entry relating to the goods in the Poisons Standard;
- the indications for the goods;
- the dosage form of the goods and their physical appearance;
- the names and quantities of therapeutically active substances in the goods;
- the routes of administration of the goods; and
- the type of container in which the goods are to be packed;
- if the goods are a kind of medical device:
- the intended purpose of the device;
- the device nomenclature system code specified for the device; and
- the medical device classification applying to the device; and
- whether the goods are a designated orphan drug.