Change of ownership submissions: New request for information response deadline

Medicines regulatory news

7 December 2012

New RFI Response Deadline Implementation on all COA submissions made after 7th December 2012. A failure to respond to Request for Information within 14 calendar days from the date of the letter will result in the withdrawal of the application.

Consequences of application withdrawal:

  • The PL number for the licence will be lost and is irrecoverable. A new number will be generated if/when the applicant resubmits the application.
  • A full refund of fees will be made to the applicant (Refund policy maybe subject to a change in the future)

Page last modified: 11 December 2012