A new section has been added to the website setting out how to make a licence submission to the MHRA.
It is the intention of the MHRA to stop accepting Special Mail 5 formatted submissions for new MA applications and MA variations on 1 January 2013. From this date forward only submissions submitted in the validated NeeS and eCTD formats will be accepted.
The new section includes information on:
– marketing authorisations, variations, renewals, PSURs and BROMI applications
– Active Substance Master Files
– labels and patient information leaflets
– parallel import applications
– homeopathic applications.
The section sets out the MHRA submission requirements, including national requirements and Guidance on submitting in NeeS and eCTD formats; details of how to cancel and withdraw licences; what happens in a licence application is rejected; and responses to requests for information (RFIs) from the MHRA.
It also provides a link to the MHRA portal and information about submissions on CD or DVD.