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Making a submission

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  • Making a submission
  • Companies
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  • Timelines & submission scheduling

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.

Overview documents

  • Working with SMC - a guide for manufacturers (PDF, 247KB)
  • ABPI toolkit (PDF, 488KB)
  • Guidance on medicines outwith SMC remit (PDF, 507KB)
  • Company Information Request Form And Guidance (DOCX, 157KB)

Revised process for ultra-orphan medicines

Following the Scottish Government's announcement in June 2018 a new approach to the assessment of ultra-orphan medicines has been introduced.

Find out more

Full submissions and resubmissions: guidance and forms

SMC introduced a fast-track resubmission process from January 2020 for resubmissions where the only change is a new or improved simple Patient Access Scheme (PAS). Further information can be found in the Guidance to submitting companies- fast track resubmission process.

  • Guidance on NPAF (PDF, 757KB)
  • New product assessment form (NPAF) (DOCX, 316KB)
  • Guidance to submitting companies - fast-track resubmission process (PDF, 172KB)
  • Fast-track resubmission proforma (DOCX, 213KB)
  • Guidance supplement for ultra-orphan medicines (PDF, 521KB)
  • Ultra-orphan NPAF form (DOCX, 317KB)
  • Re-evaluation of SMC decisions (PDF, 179KB)
  • Budget impact template (XLSX, 559KB)
  • Company comments guidance (PDF, 198KB)
  • Guidance supplement EMA conditional marketing authorisation (PDF, 290KB)
  • Updated checklist of confidential information company comments (DOCX, 152KB)
  • Economic Q&A (DOC, 116KB)

Abbreviated submissions: guidance and forms

From January 2020, SMC no longer requests abbreviated submissions for paediatric licence extensions. Further information can be found in the Guidance to submitting companies on abbreviated submissions.

  • Guidance to submitting companies on abbreviated submissions (PDF, 701KB)
  • Abbreviated submission template (DOCX, 642KB)

Release of clinical, economic and indirect comparison checklists

  • Release of clinical, economic and indirect comparison checklists (overview).pdf (PDF, 182KB)
  • NDC health economic checklist (DOCX, 155KB)
  • NDC Clinical checklist (DOCX, 157KB)
  • Simulated treatment comparison (STC) Checklist (DOCX, 157KB)
  • Indirect treatment comparison (ITC) Checklist (DOCX, 146KB)
  • Mixed treatment comparison (MTC) Checklist/Network meta-analysis (NMA) Checklist (DOCX, 147KB)
  • Matching-adjusted indirect comparison (MAIC) Checklist (DOCX, 159KB)

Release of company data

  • Release of company data (PDF, 563KB)

Patient access schemes (PAS)

A Patient Access Scheme (PAS) is a scheme proposed by a pharmaceutical company in order to improve the cost-effectiveness of a medicine and enable patients to receive access to cost-effective innovative medicines.

Find out more

Patient and Clinician Engagement (PACE)

PACE is our process for assessing medicines for end of life and very rare conditions. Discover what you need to know and download the PACE statement form.

Find out more

Early engagement with companies

To support companies making submissions, in certain circumstances we offer the opportunity for an early engagement meeting.

Find out more

Companies at SMC Committee meetings

We invite pharmaceutical companies to attend our SMC Committee meetings when one of their products is being considered.

Find out more

Meetings with companies post-SMC

When a medicine is not recommended, in certain circumstance we may meet with the company to discuss next steps

Find out more

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. 

  • Guide For Patient Group Partners 2017 1mb (PDF)

    Download guide

Support to make your submission

The Public Involvement team are able to guide you through the submission process and are available by email or to speak to on the phone. If it would be of help to you, they can also meet with you to support you.

To provide a patient group submission for a medicine you complete a patient group submission form. If you have any problem accessing the electronic version of the form we can either email it to you or send you a paper version in the post. Please remember you will need to fill in a patient group registration form before you make a submission. 

You will usually have between six and eight weeks from when the appraisal is announced to complete and return your submission. The Public Involvement team will advise you on exact timelines for each submission.

The information you collect and submit will be used by the assessment team, along with other information, to prepare its reports and by the appraisal committee to develop its recommendations.

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

You can find out more about patient group submissions by watching our short film detailing a patient group's experience of the process. 

Preparing a submission for SMC - the patient group experience

Watch one of our patient group partners describe their experience of making a submission.

  • Patient group submission example (ADHD) 261kb (PDF)

    Download

Submission Forms

  • SMC Patient Group Submission Form 218kb (DOCX)

    Download
  • SMC Patient Group Partner Registration Form 205kb (DOCX)

    Download

Patient and Clinician Engagement (PACE)

PACE is our process for assessing medicines for end of life and very rare conditions. Discover what you need to know and download the PACE statement form.

Find out more

Patient group participation at SMC Committee meetings

We invite patient groups to attend our SMC Committee meeting when a medicine they have made a submission on is being considered

Find out more

Public involvement

Our Public Involvement team help bring the perspective of patients and the public to our committee's decisions.

Find out more

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.

  • SMC Product Assessment Timelines 2020 21 54kb (DOC)

    Download
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