Revised: 28 May 2013
Consultations
Outcome of Consultation on Changes to the Medsafe's Administrative Processes and Fees Effective 1 July 2009
19 June 2009
To: Medicine, related product and clinical trial sponsors and applicants Regulatory affairs staff and consultants
Changes to the Medsafe's administrative processes and fees effective 1 July 2009
The purpose of this letter is to:
- Advise you of changes to Medsafes administrative processes for the
collection of fees
and - provide an updated schedule of fees effective from 1 July 2009
1. Changes to Medsafe's administrative processes
On 1 July 2009 Medsafe will introduce new processes (signalled in April 2009) for the collection of fees payable under the Medicines Act 1981.
This change will mean that companies are no longer required to send money with an application or notification.
Following receipt of an application or notification, a tax invoice will be sent to the applicant with an acknowledgement letter. Payment will be requested within 7 days and will be required to validate the application/notification.
Reminders will be sent in relation to unpaid invoices. Applications and notifications will, however, be invalid if payment has not been received by the 20th of the month following the month in which the invoice was issued.
Applicants and sponsors should note that:
- A tax invoice will be issued for each application. The invoice number must be quoted when payment is submitted.
- If you make a single payment covering several invoices please remember to cite all relevant invoice numbers on your remittance advice
- All invoices will be issued in the name of the sponsor. Where payment is to be made by another party, the sponsor and applicant will need to arrange this.
- An application will not be valid, and processing of the application will not proceed, until the invoice has been paid.
- Applicants will be able to request an emailed acknowledgement letter and invoice by ticking the appropriate box on the application form and provide an email address. Updated application forms will need to be used from 1 July 2009. These will be available on the Medsafe website (www.medsafe.govt.nz).
- A revised fee schedule will come into effect on 1 July 2009 (see further details below).
- Payment should not be sent with an application. A short transition period will be allowed, after which time upfront payments will be returned to the applicant.
2. Updated schedule of fees
In April 2009, Medsafe undertook consultation on proposed changes to fees payable under the Medicines Act 1981. The outcome of that consultation is available on the Medsafe website (www.medsafe.govt.nz).
Some of the proposed changes will be implemented, while others will not proceed at this time. However, it is important to note that in almost all instances, the actual fees or the way in which fees are calculated will change on 1 July 2009. From this date, Changed Medicine Notification fees will reduce by 10% and certain fees relating to New Medicine Applications will no longer apply.
The fees are shown in the revised fee schedule.
The revised fees apply to applications received from 1 July 2009 onwards. The current fee schedule applies to all applications received up to and including 30 June 2009.
If you have any queries about the information provided in this letter, please contact:
Brian Strickland
Business Manager
askmedsafe@health.govt.nz
