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Key date for sponsors of biologicals - 30 November 2012

26 October 2012

The TGA advises sponsors of products previously exempt from ARTG entry to submit the application to include their biological in the ARTG before 30 November 2012.

The Australian regulatory framework for biologicals came into effect on 31 May 2011. Transition arrangements have been included in the legislation to provide sufficient time for the sector to make any changes necessary to comply with the new requirements of the biologicals framework.

30 November 2012 is a key date for sponsors of biologicals that are currently supplied in Australia but are not currently included in the Australian Register of Therapeutic Goods (ARTG). These sponsors include tissue banks supplying:

• bone products
• skin products
• ocular products
• cardiovascular products
• other biological products.

Sponsors will be able to continue to supply a product until the TGA has reached a decision, even in the unlikely event that this decision is reached after 31 May 2014 if:

• the biological was supplied prior to 31 May 2011
• and
• an application is submitted to the TGA for inclusion of the biological into the ARTG on or before 30 November 2012.

Application requirements

An application must include:

• the electronic application form for a biological (eBS application form)
• the product dossier and any other documents that are required by the application form
• payment of the application fee (an invoice is raised at the time the electronic application form is submitted).

Sponsors are advised to allow sufficient time for processing of invoices.

Organisations that are eligible for the Australian Government Funding are provided with the following advice to ensure the requirement for payment of the application fee is met by 30 November 2012:

• ensure that the eligibility status of the facility has been confirmed as soon as possible
• do not pay the application invoice that is generated on submission of the application, refer to the instructions on claiming government funding to apply for offset of fees
• ensure that the application for offset of the invoice is submitted prior to 30 November 2012

What happens if applications are submitted after 30 November 2012?

Sponsors are still able to make applications after 30 November 2012. However if the TGA has not made a decision by 31 May 2014, then the sponsor will no longer be able to supply that biological until the product is included in the ARTG.

Australian Government funding of the direct regulatory costs for not-for-profit hospital supply units and Australian publicly funded facilities continues until 31 May 2014.

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