Making a submission

We provide 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:

• vaccines
• generics
• pharmacy and general sales list medicines
• blood products, and
• diagnostics.

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).

Details of how we work with pharmaceutical companies can be found in our guide, Working with SMC - a guide for manufacturers. Our full submission process requires 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. For more advice on making a submission, please get in touch via our contact us page. 

In the event that the SMC secretariat has not communicated directly with a company to discuss submission plans, companies are required to communicate with us via our contact page prior to making a submission or resubmission.

All documents relating to company submissions can be viewed and downloaded from this page.

Understanding how new medicines impact the quality of life of patients and carers is an important part of the SMC decision making process.

We work in partnership with patient groups from around the country to capture the experiences of patients, their families and carers via our patient group submission process. Our Guide for patient group partners explains what type of information you need to capture the views and experiences of the patients and carers you represent. 

A company may make a submission for a product once it has received a positive opinion from the European Medicines Agency (EMA) Committee for Medicinal Products for Human Use (CHMP) or approval from the Medicine and Healthcare products Regulatory Agency (MHRA).

In the event that the SMC secretariat has not communicated directly with a company to discuss submission plans, companies are required to communicate with us via our contact page prior to making a submission or resubmission.

The usual assessment timeline is 18 weeks, i.e. from scheduling of a submission to publication of advice. A longer timeline, e.g. 22 - 26 weeks, is required for submissions for:

• end of life / orphan medicines that require a Patient and Clinician Engagement (PACE) meeting
• medicines with a complex patient access scheme (PAS), and
• occasionally for complex submissions e.g. ones which include multiple clinical studies or analyses.

Our 18 week detailed product assessment timelines are a guide only. In periods where a high number of submissions is received we may need to prioritise submissions to meet the needs of patients, prescribers and the healthcare system.

When it is necessary to prioritise submissions for assessment we take into account factors including:

• Patient need: As agreed with NHS boards and our industry User Group Forum, we may prioritise submissions for medicines where there is exceptionally high patient need. For example, a submission for a medicine used for a condition where no other treatment is available may be prioritised over one where an alternative treatment is available

• Health service need: This includes consideration of, for example, a situation where an unlicensed product is currently being used or where an existing treatment requires a specialist service for delivery

• First in class medicine: A submission for a 'first in class' (i.e. the first of its kind) medicine would generally be given a high priority

• Date that product is due to become available in the UK: A submission for a medicine that is already available may be prioritised over others that do not yet have marketing authorisation, and

• Patient Access Scheme Assessment Group (PASAG) timeline: If a submission involves a complex PAS, NDC will not consider the medicine until a PASAG decision on the operational feasibility of the scheme is available.

We have agreed with NHSScotland and the Association of the British Pharmaceutical Industry (ABPI) that from July 2014:

• The monthly submission dates that SMC generally works to will be removed for medicines for end of life /orphan conditions
• Submissions for these medicines will be scheduled for assessment in order of date and time received
• For medicines where there is exceptionally high patient need, e.g. no other treatment available, SMC may schedule the submission earlier

This is a change to the SMC process to ensure that these submissions are considered as quickly as possible for the benefit of patients.