National Health (Pharmaceuticals and Vaccines—Cost Recovery) Regulations 2022
81Application for services received, and notification given, before commencement day
Start here
Get a plain-English read of 81
Turn the raw legal text into a practical explanation grounded in National Health (Pharmaceuticals and Vaccines—Cost Recovery) Regulations 2022.
81 Application for services received, and notification given, before commencement day
(1) If: (a) an application for the provision of submission services made under Part 2 of the old Regulations was received by the Department before the commencement day; and (b) the Secretary had given a notification relating to the application, or the prior notice of the application (if any), under the old Regulations before the commencement day; and (c) the application had not been withdrawn before the commencement day; and (d) the assessment of the application had not been completed before the commencement day; this instrument applies: (e) in relation to the application—as if it were a submission made under Part 3 of this instrument for the provision of the submission services; and (f) in relation to the notification—as if it had been given under section 33 of this instrument.
Note: Other provisions in this instrument will also apply in relation to the submission and the notification, for example, section 34 (Secretary may refuse to accept incomplete submission), section 35 (withdrawal of notice of intent or submission, and refund of fee or liability for deposit), section 36 (remaking submissions), section 37 (Secretary may determine evaluation category that submission is in) and section 38 (assessing submissions).
(2) If: (a) an application for the provision of services (the relevant services) made under the old Regulations (other than an application for the provision of submission services made under Part 2 of the old Regulations) was received by the Department before the commencement day; and (b) the Secretary had given a notification relating to the application, or the prior notice of the application (if any), under the old Regulations before the commencement day; and (c) the application had not been withdrawn before the commencement day; and (d) the assessment of the application had not been completed before the commencement day; this instrument applies: (e) in relation to the application—as if it were an application made under this instrument for the provision of the relevant services; and (f) in relation to the notification—as if it had been given under section 11, 17, 50 or 58 (as the case requires) of this instrument.
Note: Other provisions in this instrument will also apply in relation to the application, for example:
(a) in relation to an ATAGI application—section 12 (withdrawal of notice of intent or ATAGI application, and refund of fee or liability for deposit) and section 13 (remaking ATAGI applications); and
(b) in relation to a pre‑submission meeting application—section 18 (withdrawal of pre‑submission meeting application, and refund of fee) and section 19 (remaking pre‑submission meeting applications); and
(c) in relation to a pricing application—section 51 (withdrawal of notice of intent or pricing application, and refund of fee or liability for deposit), section 52 (Secretary may determine pricing category that pricing application is in), section 53 (cessation of pricing services 6 months after pricing application is made) and section 54 (refund if deed not made within 6 months after pricing application is made); and
(d) in relation to a list management application—section 59 (withdrawal of list management application, and refund of fee) and section 60 (refund of part of fee if replacement for expired deed not made).