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Document What is the timescale and decision process when applying to get a product included in Part IX of the Drug Tariff?

A manufacturer should complete DT1A and B application form from our website and submit it (preferably electronically). The application will be acknowledge and the applicant will be advised of the samples and packaging that are required to complete the application process. 

Once received, the application is assessed in date order.

The Pharmaceutical Specialists assess the application against 3 main criteria:
  • Appropriateness to prescribe.
     
  • Safety and Quality.
     
  • Cost Effectiveness.
If a product meets these criteria it will then be discussed at a review meeting and a listing decision will be made.
 
Click here for more thorough information regarding the assessment process on our website:

 
Timeframe
 
Below is an example of the minimum time from receipt to approval and publishing in the Drug Tariff.
 
Activity Number of working days Example date
Application received N/A 01/09/16
Application acknowledged 5 08/09/16
Application assessed and taken to a meeting 20 06/10/16
Acceptance letter written 5 13/10/16
Confirmation of detail of entry and supplies available 35 1/12/16
Month listed in the Drug Tariff N/A December 2016

A number of factors may cause this timeline to be extended e.g. missing documentation, complexity of information to be evaluated, applicants needing time to provide further information. An application will not be released for assessment until all the necessary information has been received. The point in the month the application is confirmed in relation to the print cycle of the Tariff may also delay the entry by a month.

NHS Information Services are further behind with the assessment of applications than they would like. You can track the progress of your application here.
 
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