Section 42 of the Medicines and Poisons (Medicines) Regulation 2021 (MPMR) requires the holder of a substance authority to give notice to the chief executive of Queensland Health (or delegate) if any changes affecting the authority are proposed, as soon as practicable, but no later than 5 business days, after the change of circumstances happens — this form must be used for this purpose.
The following changes must be notified by a substance authority holder under section 42(1) of the MPMR:
- a change to an authorised place stated in the substance authority;
- a change to a relevant person stated in the substance authority;
- if the substance authority is a manufacturing licence – a change to the person who is appointed to supervise manufacturing under the licence;
- another change to the substance authority holder’s circumstances that substantially affects the holder’s ability to comply with a condition of the authority.
Before completing this form, please carefully read the following Privacy Statement:
Personal information collected by Queensland Health is handled in accordance with the Information Privacy Act 2009. Queensland Health is collecting your personal information on this notice under authority of the Medicines and Poisons Act 2019. The information is being collected to ensure that health risks arising from the use of regulated substances are appropriately managed. All personal information will be securely stored and only accessible by Queensland Health. Your personal information will not be disclosed to any other third parties without consent unless the disclosure is authorised or required by law. Failure to provide information may render the form incomplete, which may constitute an offence under the Medicines and Poisons Act 2019.
For information about how Queensland Health protects your personal information, or to learn about your right to access your own personal information, please see our website at www.health.qld.gov.au/global/privacy.
This notice is managed by the Healthcare Approvals and Regulation Unit (HARU). Should you require assistance in completing this form, please email: HARU@health.qld.gov.au.
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MPMR-42, Version 1