Published: 23 March 2020
Updated 17 July 2020

Medicines

Submitting applications electronically to Medsafe

Due to the response to COVID-19 and what this means for our staff and operations, Medsafe cannot receive CDs and hard copies until further notice.

With the COVID-19 restrictions affecting both pharmaceutical companies and Government agencies, Medsafe has rolled out our secure electronic file transfer system (EFT) to companies. This will assist regulatory personnel working from home to submit applications to Medsafe.

The EFT is a secure system as the file is encrypted in transit and then stored on a secure server within the Ministry of Health. While the system has both drop-off and pick-up functions, Medsafe will only be using the system for receiving applications. All other aspects will remain in accordance with usual Medsafe processes.

Please be aware that this is a new temporary system to cover this period of restrictions and there will likely be teething problems. Please carefully follow instructions on the use of the system, such as naming conventions, which may change periodically as we work through issues and solutions.

Please check this web page regularly for updates and thank you for your patience.

To get set up we will need from you:

  • the name of a contact person
  • The company of the contact person, such as the NZ sponsor, pharmaceutical company or consultancy firm if multiple sponsors will be represented
  • their email address (preferably with a company email domain)
  • their mobile number to receive the password.

Please send to medsafeapplications@health.govt.nz with EFT Set Up in the subject line.

Drug Master Files (DMFs) and Plasma Master Files (PMFs) can be submitted through the EFT. However, it is up to sponsors to make their DMF/PMF holders aware of the process and direct them to medsafeapplications@health.govt.nz .

Please ensure your DMF/PMF holders send their requests through with EFT set up - DMF or PMF in the subject line.

If you already have a set-up from our pilot, please ensure those people are the same people you need for normal submissions. They will automatically be transferred over to the new system.

Please note that there may be a delay between your request and being notified of successful registration.

Once set up, we will send you further information on how to use the system, the naming conventions required and file format.

There are no restrictions on the number of people from each company who can submit electronically.

Medsafe would also like to take this opportunity to remind sponsors of their obligations with regards to informing Medsafe of any potential out of stock situations, particularly in light of supply chain disruptions caused by COVID-19.

Information for sponsors on what to do in the case of a potential out of stock is available here.

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