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Meetings with Pharmaceutical Companies post SMC

1. SMC will try to accommodate individual meetings with pharmaceutical companies where a particular need is identified and agreed.
2. Companies may request a meeting following publication of a not recommended advice for a full or resubmission. The aim of the meeting is to help the company understand why their medicine has not been accepted and determine the nature and focus of any resubmission or independent review panel (IRP).  
3. Meetings will be submission specific, led by a representative of the SMC Executive and will be scheduled for one hour.  A minute of the meeting will not be provided.
4. A maximum of two company representatives are permitted. 
5. The standard format for meetings will be as follows:
A disclaimer:  Advice or guidance provided is the personal opinion of the SMC Executive member leading the meeting and does not guarantee that NDC/SMC would support a resubmission that subsequently encompasses the advice or guidance given.
Agreement on the purpose of the meeting: The purpose of the meeting is to support manufacturers in understanding the SMC decision and process in order that they may determine the nature and focus of a resubmission or IRP. Any specific technical questions which arise may need to be managed outwith the meeting.
Discussion of agenda items.  
Discussion of next steps
6. An evaluation feedback form will be provided to enable the company to provide feedback. 
For queries relating to post-decision meetings, please get in touch via