Medicines regulatory news
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)