Why can companies not mention the MHRA in materials for a medicine with a conditional licence?

  • 3

    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.


  • 9.5

    9.5 Promotional material must not include any reference to the Commission on Human Medicines, the Medicines and Healthcare Products Regulatory Agency or the licensing authority, unless this is specifically required by the licensing authority.

Clause 9.5 states that promotional material must not include reference to amongst others the Medicines and Healthcare products Regulatory Authority 'MHRA', further the use of an official body’s name implies that they are aware and agree to the use of their name and could be interpreted to imply some form of endorsement which may not be the case.