Biovigilance responsibilities of sponsors of biologicals
Australian requirements and recommendations
Biovigilance and the law
This guidance concerns proposed amendments to the Therapeutic Goods Act 1989. The proposed amendments have not yet become law and may be subject to change. The purpose of this guidance is to make you aware of these proposed changes if/when they take effect.
The Therapeutic Goods Amendment (2017 Measures No. 1) Bill 2017 proposes amendments to the Therapeutic Goods Act 1989 (Act). The proposed amendments have not yet been passed by Parliament and may be subject to change. A link to the Bill can be found at: Therapeutic Goods Amendment (2017 Measures No. 1) Bill 2017.
Amendment regulations to support a number of measures in this Bill are proposed, but have also not yet become law as they rely on the Bill first being in place and on the Governor General's approval of the regulations. The purpose of this guidance is to inform stakeholders about these proposed changes. While reasonable care is taken to ensure that the information is an accurate description of the proposed changes, TGA does not guarantee or warrant the accuracy, reliability, completeness or currency of the information or its usefulness in achieving any purpose. To the fullest extent permitted by law, including but not limited to under s 61A of the Act, TGA will not be liable for any loss, damage, expense or cost incurred or arising as a result of any use or reliance on this information.
Your biovigilance responsibilities outlined in this guidance are underpinned by legislation.
Under section 32DQ of the Therapeutic Goods Act 1989, you must notify us of certain matters in relation to biologicals included in the ARTG and it is a criminal offence, or a civil penalty, to fail to make such notifications. You must report the following relevant information (section 32DQ(3)):
- information that contradicts information already given by the sponsor under the Therapeutic Goods Act 1989 in relation to the biological (including information given about the quality, safety or efficacy of the biological)
- information that indicates that the use of the biological in accordance with the recommendations for its use may have an unintended harmful effect
- information that indicates that the biological, when used in accordance with the recommendations for its use, may not be as effective as the application for inclusion of the biological in the ARTG or information already given by the sponsor under the Therapeutic Goods Act 1989 suggests
The specified periods within which you must comply for the purposes of section 32DQ of the Therapeutic Goods Act 1989 are prescribed in paragraph 16AB of the Therapeutic Goods Regulations 1990.
Our requirements do not override any applicable privacy laws.
General privacy information is available on our website.
Sections 32EC and 32ED of the Therapeutic Goods Act 1989 allow us to impose certain conditions at the time of inclusion of a biological in the ARTG and section 32EE of the Therapeutic Goods Act 1989 allows us to impose new conditions and remove or vary existing conditions at any time while the biological remains included in the ARTG. Requirements imposed as conditions of inclusion under sections 32EC and 32ED continue to apply for biologicals where the application has been withdrawn or lapses, where the Secretary gives notice in accordance with section 32DR of the Therapeutic Goods Act 1989.
Under paragraph 5(a) of the Therapeutic Goods (Biologicals - Conditions of Inclusion in Register) Determination 2017, the legislative instrument made under subsection 32EC(2) of the Therapeutic Goods Act 1989, you must comply with the record-keeping requirements and the reporting requirements set out in this guidance document.
Under sections 32EF, 32EG and 32GC of the Therapeutic Goods Act 1989, we can cancel or suspend a biological from the ARTG for refusing or failing to comply with conditions of inclusion in the ARTG. Section 21A of the Therapeutic Goods Act 1989 specifies the grounds for prosecuting offences related to not complying with conditions of inclusion.