Early engagement with companies
The Scottish Medicines Consortium (SMC) provides the opportunity for pharmaceutical companies to meet with SMC staff, prior to submission for a newly licensed medicine in specific circumstances.
The main purpose of these early engagement meetings is to support pharmaceutical companies in understanding SMC processes in order that they may determine the nature and focus of a submission and to help NHSScotland by reducing the number of non-submissions to SMC. Pharmaceutical companies may then be able to produce a high quality submission for review by SMC where they previously felt unable to submit.
As we are unable to facilitate meetings for all potential submissions, early engagement meetings with an individual pharmaceutical company will take place only in specific circumstances, as detailed below.
Early engagement meetings will be considered where:
- Intelligence suggests a submission may not be forthcoming and where there is exceptionally high patient need, for example a medicine used for a condition where no other treatment is available.
- A company has had limited previous experience of engagement with SMC, and/or aspects of the submission suggest there would be mutual benefit from a meeting, to discuss concerns or issues relating to SMC process or policy at an early stage.
These criteria are not exhaustive and we will retain the flexibility to hold a meeting when it is considered this would be mutually beneficial to both the company and SMC. Meetings will be focused on a single submission.
Some examples of medicines that may be discussed include those in the Early Access to Medicines Scheme, validated ultra-orphan medicines and Advanced Therapy Medicinal Products.
Where a pharmaceutical company has a query on submission requirements that is not clearly addressed in the guidance documents on the website, the SMC Secretariat should be contacted by email for advice on how to proceed.
To request an early engagement meeting, we ask that you complete and submit the early engagement information request form. The completed form should contain enough information to enable us to determine whether the submission meets the above criteria. Please note that a maximum of 3 company representatives are welcome to attend an early engagement meeting.
The meetings are held virtually, using the MS Teams platform, on a mutually agreeable date and time and are scheduled to last 1 hour.
We aim to respond within 15 working days to requests for these meetings. We will then endeavor to arrange a meeting as soon as convenient for both parties.
All communication queries and requests relating to early engagement should be directed to his.smcsubmissionportal@nhs.scot