Laws and Regulations under TRIPS Art. 63.2 - View details of the document

Australia
Therapeutic Goods Legislation Amendment (Copyright) Act 2011, No. 39, 2011
The Act amends the Copyright Act 1968 to allow the Therapeutic Goods Administration (Australia's regulatory authority for therapeutic goods) and certain third parties to use copyright material in medicinal product information. The Act entered into force on 28 May 2011. The amendments provide that acts expressly required or permitted under the Therapeutic Goods Act 1989 in respect of product information for particular medicines, and acts ancillary or incidental to expressly mentioned acts, will not infringe copyright. The supply, reproduction, publication, communication and adaption of product information in Australia is not an infringement of copyright, provided it is done for a purpose related to the safe and effective use of the specified medicine. This exception applies to acts done after the commencement of the amendments (28 May 2011), irrespective of when the product information was approved, and covers acts of the Commonwealth, generic companies and healthcare professionals.