SCOTTISH MEDICINES CONSORTIUM

NHS SCOTLAND

Providing advice about the status of all newly licensed medicines

Submission Process

The SMC Process requires pharmaceutical companies to complete a New Product Assessment Form (NPAF). SMC aim to issue advice to  NHSScotland on all newly licenced medicines within 12 weeks of products being made available.

For further details on how to make a submission contact the secretariat - email: smcsecretariat@nhshealthquality.org or download a copy of the New Product Assessment Form and Guidance to Manufacturers.

For companies requiring guidance on the submission or evaluation process please contact fgrierson@abpi.org.uk

Click on the document titles to download:

• Guidance on Submission Criteria  Guidance regarding exclusion and submission critera for full and abbreviated submissions  
• Product Assessment Flowchart  
  Flowchart outlining assessment process.
• Product Asessment Timelines  Timelines for submission and review 
• New Product Assessment Form
  Template for Full Submissions.
• Guidance to Manufacturers
  Guidance for the completion of New Product Assessment Form for Full Submissions.
• Guidance to Manufacturers 
  Economic Question and Answer Document.
• Economic Checklist Template
  Economic Checklist Template.
• Abbreviated Submission Form and Guidance Notes
  Template and Guidance to Manufacturers for completion of Abbreviated Submission Form.
• Summary of Information to Patients Template
  Template for submission of evidence which may be completed by industry as a supplement for patient and public interest groups making a submission.
• Patient Interest Group Submission Template
  Template for Submission.
• Guidance to Making a Patient Interest Group Submission 
  Guidance to Patient Interest Groups
• Costing - Frequently Asked Questions (PDF, 40.5KB)
  Costing - Frequently Asked Questions
• SMC process for issuing ‘not recommended’ advice due to non-submission by a pharmaceutical company Process for issuing 'not recommeded' advice due to a non-submission
• SMC Submission Requirements - Flowchart

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