Form B provides comprehensive information and is used by us, together with additional information, to prepare an assessment report for AWMSG. This report is one of the documents submitted for the AWMSG appraisal meeting.
You should submit a Form B after receiving our request and confirmation (by email or letter) of the appraisal scope. You can submit a completed Form B before a medicine receives marketing authorisation and up to three months after.
Fill in the Form B using the documents provided in the Form B submission pack and send it to awttc@wales.nhs.uk. It is essential to refer to our Form B guidance notes when filling in the Form B; not doing so may result in an inadequate submission.
There is a limit to the file size that our email mailbox will accept and zip files will be blocked by NHS Wales email security. As an alternative to email, companies may wish to upload large/zip files and documents containing commercially sensitive information directly to the AWTTC Vault, a secure file sharing portal. Please contact us to arrange secure access to our Vault.
We will confirm (by email or letter) whether the submitted Form B is consistent with the scope agreed and will clarify the appraisal schedule. Please note that an appraisal date won't be scheduled until the applicant company has provided a complete submission.
Your medicine will be listed on this website once you have submitted a Form B. The entry will give basic details about the medicine and the dates of the scheduled appraisal meetings. The status of the medicine will be 'In progress' until the AWMSG appraisal process is complete and the recommendation has been published. Your submitted Form A and Form B will never be published on our website.