Published: 23 March 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 is rolling out our secure electronic file transfer system (EFT) to companies. This will assist regulatory personnel working from home to submit applications to Medsafe.

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.

To get set up we will need from you:

  • the name of a contact person
  • their email address
  • their mobile number to receive the password.

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

Please ensure your DMF holders send their requests through with EFT set up – DMF 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.

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

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

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 in accordance with usual Medsafe processes.

At present we are limiting the number of people from each company who can submit electronically to 3 people. This may be revised further down the track. These people must have a mobile phone.

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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