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.
Collection notice:
The Department of Health is collecting your information in accordance with Section 42 of the Medicines and Poisons (Medicines) Regulation 2021 in order to meet reporting requirements for a substance authority holder. Personal information collected by the Department of Health is handled in accordance with the Information Privacy Act 2009. The personal information provided by you may be disclosed to a Hospital and Health Service, Public Health Unit for the purpose of carrying out compliance activity. Your personal information will not be disclosed to other third parties without consent, unless the disclosure is authorised or required by or under law.
For any questions regarding this collection notice, please contact Medicines Approvals and Regulation Unit (MARU) via email: MARU@health.qld.gov.au. For information about how the Department of Health protects your personal information, how to access or correct your own personal information, or how to make a complaint about a breach of the privacy principles and learn how we deal with such a complaint, please refer to: The Department of Health’s Privacy Policy.
Contact information
This notice is managed by the Medicines Approvals and Regulation Unit (MARU). Should you require assistance in completing this form, please email: MARU@health.qld.gov.au.
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