Submission guidance and templates for submission
SMC provides advice to NHS Boards and their Area Drug and Therapeutics Committees (ADTCs) across Scotland about the status of all newly licensed medicines and all new formulations and new indications of established products. We aim to make this advice available as soon as practical after the launch of the product involved.
The SMC remit is confined to prescription only medicines (POMs). We do not assess:
- pharmacy and general sales list medicines
- blood products
Devices that contain a medicine are only assessed if they have been licensed as a medicine by the Medicines and Healthcare products Regulatory Agency (MHRA) or the European Medicines Agency (EMA).
Our full submission process requires pharmaceutical companies to complete a New Product Assessment Form (NPAF).
The Association of the British Pharmaceutical Industry (ABPI), in partnership with SMC, has developed a toolkit for industry representatives to help them with their submissions.