Clause 11

11.1

(3.1) A medicine must not be promoted prior to the grant of the marketing authorisation which permits its sale or supply subject to the provisions of Clause 11.3 below.

11.2

(3.2) The promotion of a medicine must be in accordance with the terms of its marketing authorisation and must not be inconsistent with the particulars listed in its summary of product characteristics subject to the provisions of Clause 11.3 below.

11.3

(New) A medicine with a temporary supply authorisation must not be promoted unless it is part of a campaign that has been approved by the health ministers.