Medicines and Poisons (Medicines) Regulation 2021
sec.42Notification of particular changes affecting authority
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sec.42 Notification of particular changes affecting authority
The holder of a substance authority must give notice to the chief executive in the approved form if any of the following changes are proposed by the holder— a change to an authorised place stated in the authority; a change to a relevant person stated in the 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 holder’s circumstances that substantially affects the holder’s ability to comply with a condition of the authority. a fire at an authorised place stated in a wholesale licence damages stock of medicines and the security system at the place The notice must be given as soon as practicable, but no later than 5 business days, after the change of circumstances happens. (sec.42-ssec.1) The holder of a substance authority must give notice to the chief executive in the approved form if any of the following changes are proposed by the holder— a change to an authorised place stated in the authority; a change to a relevant person stated in the 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 holder’s circumstances that substantially affects the holder’s ability to comply with a condition of the authority. a fire at an authorised place stated in a wholesale licence damages stock of medicines and the security system at the place (sec.42-ssec.2) The notice must be given as soon as practicable, but no later than 5 business days, after the change of circumstances happens.
- (a) a change to an authorised place stated in the authority;
- (b) a change to a relevant person stated in the authority;
- (c) if the substance authority is a manufacturing licence—a change to the person who is appointed to supervise manufacturing under the licence;
- (d) another change to the holder’s circumstances that substantially affects the holder’s ability to comply with a condition of the authority. Example for paragraph (d) — a fire at an authorised place stated in a wholesale licence damages stock of medicines and the security system at the place