Clause 3 - Marketing Authorization
The legitimate exchange of medical and scientific information during the development of a medicine is not prohibited provided that any such information or activity does not constitute promotion which is prohibited under this or any other clause.
3.1 A medicine must not be promoted prior to the grant of the marketing authorization which permits its sale or supply.
- Supplementary information
- Clause 3.1 Advance Notification of New Products or Product Changes which May Significantly Affect Expenditure
3.2 The promotion of a medicine must be in accordance with the terms of its marketing authorization and must not be inconsistent with the particulars listed in its summary of product characteristics.
A medicine must not be promoted prior to the grant of its marketing authorization which permits its sale or supply.
Clause 3 supplementary information provides more information and the PMCPA Guidance on Clause 3 Market Authorization (currently being updated) may also be helpful in this regard.