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Pre-licence activity

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Guidance about Clause 3

Following a number of cases the Code of Practice Appeal Board considered it would be helpful to provide guidance on the application of Clause 3 to various activities.

 Clause 3​  prohibits the promotion of a medicine prior to the grant of its marketing authorization. It also requires that promotion must be in accordance with the marketing authorization and not be inconsistent with the summary of product characteristics (SPC).

The supplementary information to  Clause 3​  provides additional detail, including a clear statement that the legitimate exchange of medical and scientific information during the development of a medicine is not prohibited provided that this does not constitute promotion which is prohibited by  Clause 3​ ​ or any other clause in the Code.

The following Guidance about Clause 3.pdf has been updated to reflect the 2016 edition of the Code: 
 

 

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