Clause 11 Marketing Authorisation and Temporary Supply Authorisation

Clause 11
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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.

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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.

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AUTH/3737/2/23 Health professional v Novo Nordisk – Breach: 5.1, 11.2, 12.1 No breach: 2, 26.1 Applicable Code: 2021 Received: 13 February 2023 Completed: 27 November 2023 AUTH/3687/8/22 - Complainant v AstraZeneca Breach: 5.1, 11.2, 26.1 No breach: 2, 3.1, 3.3, 3.6, 5.1, 11.1 Applicable Code: 2021 Received: 18 August 2022 Completed: 18 August 2023 AUTH/3682/8/22 - Complainant v Accord Breach: 11.2, 17.2 No breach: 2, 5.1 Applicable Code: 2021 Received: 05 August 2022 Completed: 14 July 2023 AUTH/3678/8/22 - Complainant v AstraZeneca Breach: 2, 5.1, 6.1, 6.2, 11.2, 12.7 Applicable Code: 2021 Received: 01 August 2022 Completed: 04 July 2023 AUTH/3645/5/22 - Complainant v Proveca Breach: 5.1, 8.1, 11.2, 12.1, 12.3, 12.6, 12.9 No breach: 2, 5.1, 12.3, 26.1, 26.2 Applicable Code: 2021 Received: 12 May 2022 Completed: 29 June 2023 AUTH/3643/5/22 - Complainant v Novartis Breach: 5.1, 6.1, 6.2, 11.2, 12.1 No breach: 2, 5.1, 5.2, 6.3 Applicable Code: 2021 Received: 08 May 2022 Completed: 24 May 2023 AUTH/3618/3/22 - Complainant v AstraZeneca Breach: 2, 5.1, 6.1, 6.2, 11.2, 14.4 No breach: 6.2, 17.9 Applicable Code: 2021 Received: 11 March 2022 Completed: 03 April 2023 AUTH/3624/3/22 - Complainant v Pacira BioScience Breach: 5.1, 6.1, 6.2, 11.2, 14.4 No breach: 6.1, 6.4, 11.2, 14.1, 14.4, 17.9 Applicable Code: 2021 Received: 16 March 2022 Completed: 23 March 2023 AUTH/3561/9/21 - Ex-employee v AstraZeneca Breach: 2, 5.1, 6.1, 8.1, 11.2, 26.1, 26.2 No breach: 3.1, 11.1, 26.1 Applicable Code: 2021 Received: 24 September 2021 Completed: 19 August 2022 AUTH/3709/11/22 - Health professional v AstraZeneca Breach: 5.1, 6.1, 6.2, 14.4 No breach: 11.2 Applicable Code: 2021 Received: 16 November 2022 Completed: 20 October 2023 AUTH/3670/6/22 - Health Professional v Novartis Breach: 5.1, 12.9 No breach: 2, 5.1, 6.1, 6.2, 11.2, 14.4 Applicable Code: 2021 Received: 30 June 2022 Completed: 03 July 2023 AUTH/3658/6/22 - Complainant v Novartis No breach: 2, 5.1, 8.1, 11.2 Applicable Code: 2021 Received: 13 June 2022 Completed: 19 June 2023 AUTH/3659/6/22 - Complainant v Teva Breach: 5.1, 12.6, 12.10, 16.1 No breach: 2, 3.6, 5.1, 6.1, 6.2, 11.2, 26.2 Applicable Code: 2021 Received: 15 June 2022 Completed: 19 June 2023 AUTH/3663/6/22 - Complainant v Roche No breach: 2, 3.2, 5.1, 11.2 Applicable Code: 2021 Received: 19 June 2022 Completed: 14 June 2023 AUTH/3667/6/22 - Health professional v Roche No breach: 2, 5.1, 8.1, 11.2 Applicable Code: 2021 Received: 26 June 2022 Completed: 14 June 2023 AUTH/3638/4/22 - Complainant v Novartis Breach: 5.1, 6.1, 6.2 No breach: 2, 5.1, 6.1, 6.2, 11.2 Applicable Code: 2021 Received: 24 April 2022 Completed: 20 April 2023 AUTH/3592/12/21 - Bayer v Janssen No breach: 2, 5.1, 6.1, 6.2, 6.3, 6.4, 6.6, 11.2, 14.1 Applicable Code: 2021 Received: 17 December 2021 Completed: 03 March 2023 AUTH/3611/2/22 - Complainant v Daiichi Sankyo Breach: 2, 5.1, 6.1, 6.2 No breach: 6.1, 11.2 Applicable Code: 2021 Received: 14 February 2022 Completed: 23 February 2023 AUTH/3612/2/22 - Complainant v Daiichi Sankyo Breach: 2, 5.1, 12.5 No breach: 2, 5.1, 11.2, 12.5, 26.1 Applicable Code: 2021 Received: 19 February 2022 Completed: 23 February 2023 AUTH/3622/3/22 - Complainant v AstraZeneca No breach: 2, 5.1, 6.1, 11.2 Applicable Code: 2021 Received: 15 March 2022 Completed: 16 December 2022 AUTH/3571/10/21 - Complainant v Merck Serono No breach: 2, 5.1, 6.1, 6.2, 11.2, 14.1 Applicable Code: 2021 Received: 22 October 2021 Completed: 27 July 2022 AUTH/3541/7/21 - A health professional v Roche Breach: 6.1, 6.2, 12.3 No breach: 2, 5.1, 6.1, 6.2, 6.5, 11.2, 14.1 Applicable Code: 2021 Received: 15 July 2021 Completed: 27 May 2022

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.

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Please check the date of the Code that applies to the Case that you are looking at. The date of the complaint may vary from the activity/material alleged to have been in breach.