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Templates / Guidance for Submission


Working with SMC - a guide for manufacturers

Guidance on medicines outwith SMC remit

Company information request form and guidance  Template for completion by companies if unsure whether a product is within SMC remit or if they are unsure about the type of submission required.

Product assessment flowchart

Full submissions: guidance and forms

New Product Assessment Form (NPAF) Form for full submissions.

Budget impact template

Guidance to manufacturers on NPAF

Guidance for manufacturers: supplement for medicines for end of life and very rare conditions

Guidance for manufacturers on summary of information (SIPs) for patient groups                           

Summary information for submitting patient groups form

Economic question and answer document

Abbreviated submissions: guidance and forms

Abbreviated submission form and guidance notes

Patient Access Scheme (PAS): guidance and forms

Please see our Patient Access Scheme (PAS) page for more details

SMC policy statements

Please see our policy statements page for more details

For more advice on making a submission, please contact Companies can also contact the SMC Committee's Lead Pharmaceutical Industry Representative, Dr Catriona McMahon, via