Clause 18


Clauses 6 and 14 may also be relevant.


(7.1) Upon reasonable request, a company must promptly provide health professionals and other relevant decision makers with accurate and relevant information about the medicines which the company markets.


(7.5) Substantiation for any information, claim or comparison must be provided as soon as possible, and certainly within ten working days, at the request of health professionals or other relevant decision makers. The validity of indications approved in the marketing authorisation can be substantiated by provision of the summary of product characteristics.