Templates/Guidance for Submission
Working with SMC - A Guide for Manufacturers
Working with SMC - A Guide for Manufacturers provides manufacturers with an overview of the SMC remit and associated process within one document.
Submission Requirements for Full and Abbreviated Submissions
Guidance on Submission Criteria
Guidance regarding exclusion and submission criteria for full and abbreviated submissions
Templates/Guidance Required for a Full Submission
New Product Assessment Form (NPAF)
Template for Full Submissions
Guidance to Manufacturers
Guidance for completion of New Product Assessment Form for Full Submissions
Summary of Information to Patients
Template for submission of evidence which may be completed by industry as a supplement for patient and public interest groups making a submission.
Economic Question and Answer Document
Costing – Frequently Asked Questions
Template/Guidance for completion of a Patient Access Scheme
Documentation and Guidance Notes Required for completion of a Patient Access Scheme
Template/Guidance Required for an Abbreviated Submission
Abbreviated Submission Form and Guidance Notes
Template and Guidance to Manufacturers for completion of Abbreviated Submission Form
SMC Policy/Process Statements
Within this section you will find SMC policy statements relating to modifiers, biosimilar medicines, Process for a Resubmission/IRP, Policy for Meetings with Manufacturers and other position statements which you find helpful.
Further details on how to make a submission
e-mail: smcsecretariat@nhshealthquality.org
Companies requiring guidance from ABPI on the submission or assessment process
e-mail: sauld@abpi.org.uk