Fees
Schedule of Fees
Effective from 3 March 2008
On the 17 July 2006, the Governor General approved, by Order in Council, the making of the Medicines (Fees) Amendment Regulations 2006 and the Misuse of Drugs (Fees) Amendment Regulations 2006; these will be effective from 21 August 2006.
The fees applying to the various types of applications and notifications are listed below. All fees are GST inclusive.
Application for consent to distribute a new medicine (incl. a new combination product) containing a new active pharmaceutical ingredient
$122,625 for 1 strength of 1 dose form
(plus additional fees for any additional names/dose forms/strengths/flavours -
see NMA form for details)
Application for consent to distribute a new medicine (incl. a new combination product) containing a new active pharmaceutical ingredient, using the Abbreviated Evaluation process.
$33,750
(No additional fee for any additional names/dose forms/strengths/flavours
if included with parent application)
Application for consent to distribute a new multi-source prescription medicine containing one or more active ingredients
$43,875 for 1 strength of 1 dose form
(plus additional fees for any additional names/dose
forms/strengths/flavours -
see NMA form for details)
Application for consent to distribute a new prescription medicine containing one or more active ingredients, using the Abbreviated Evaluation process.
$16,875
No additional fee for any additional names/dose forms/strengths/flavours if
included with parent application)
Application for consent to distribute a new Non-prescription medicine containing one or more active ingredients
$7,650 for 1 strength of 1 dose form
(plus additional fees for any additional names/dose
forms/strengths/flavours -
see NMA form for details)
Application for consent to distribute a new name, dose form, strength, clasification or flavour of a currently distributed medicine or related product or a new combination pack containing two or more currently distributed medicines
(See relevant NMA or NRPA form for details)
Application for consent to distribute a new related product
$ 5,500
(plus additional fees for any additional names/dose
forms/strengths/classifications/flavours -
see NRPA form for details)
Application for provisional consent to distribute a new medicine
$ 8,437
Application for renewal of provisional consent
$ 500
(Plus an additional fee of $400 for each additional name/dose
form/strength/flavour)
Material change(s)
(See CMN Form A or CMN Form B or CRPN form for
details)
Self-assessable change(s)
Note: No fee is payable if a self-assessable change(s) is notified at the same
time as another assessable change(s) for which a CMN or CRPN fee is payable.
$ 400
(For any number of self-assessable changes to a single product or data
sheet)
Application for consent to conduct a clinical trial
$ 9,843
Appeal to the Medicines Review Committee
$ 9,000
Issue of a Certificate of Pharmaceutical Product
$ 250
(For each name, dose form, strength and flavour of each product
and each country for which a certificate is required.)