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Meetings with Manufacturers

1.  SMC will try to accommodate individual meetings with manufacturers where a particular need is identified and agreed.

SMC will not, however, meet with individual companies to discuss or advise on a specific submission to SMC, prior to the manufacturer making that submission. Where the manufacturer has a particular query on submission requirements that is not addressed in the Guidance for Manufacturers, it should contact the Secretariat for advice on how to proceed.
 

2.  SMC will only meet with manufacturers to discuss submissions after advice has been published for a full or resubmission. Meetings will take place in response to a manufacturer’s request and normally when ‘not recommended’ advice has been issued for a product.

3.  SMC Vice chairs, NDC chair or NDC vice-chairs and a member of the Secretariat may represent SMC at meetings with individual manufacturers. The SMC chair or individual members of the clinical assessment team or health economics team will not be present at the meetings.  

4.  A maximum of three representatives may represent the manufacturer.

5. The standard format for meetings will be as follows:

  • Introductions.
     
  • A disclaimer: The SMC representatives can only provide a flavour of the discussion that has taken place at NDC/SMC. Any advice or guidance that is provided by the SMC representatives does not guarantee that NDC/SMC would support a resubmission that subsequently encompasses that advice or guidance.
     
  • 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 action note of the meeting will be taken and shared with the manufacturer along with an evaluation form giving the manufacturer the opportunity to provide feedback on the nature and content of the meeting.