Submission Guidance and Templates for Industry
Scottish Medicines Consortium (SMC) provide advice to NHS Boards and their Area Drug and Therapeutics Committees (ADTCs) across Scotland about the status of all newly licensed medicines, all new formulations of existing medicines and new indications for established products (licensed from January 2002). This advice will be made available as soon as practical after the launch of the product involved.
The remit of SMC excludes the assessment of vaccines, branded generics, non-prescription-only medicines (POMs), blood products, plasma substitutes and diagnostic drugs. The review of device-containing medicines will be confined to those licensed as medicines by the MHRA/EMEA.
The SMC process requires pharmaceutical companies to complete a New Product Assessment Form (NPAF) for all new medicines to be assessed via the full submission process. SMC aims to issue advice to NHSScotland on all newly licensed medicines within 12 weeks of products being made available.