Guidance on letter drafting for marketing authorisation holders
Updated 4 April 2023
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This publication is available at https://www.gov.uk/government/publications/how-to-draft-a-direct-healthcare-professional-communication/guidance-on-letter-drafting-for-marketing-authorisation-holders
1. Introduction
A direct healthcare professional communication (DHPC) aims to ensure safe and effective use of a marketed medicine. Letters are sent directly to healthcare professionals by marketing authorisation holders or by the licensing authority.
Direct healthcare professional communications should not include any material that might constitute advertising or be considered promotional or commercial.
2. Guidance for marketing authorisation holders
EU good pharmacovigilance practice (GVP) Module XV (Safety communication) provides guidance to marketing authorisation holders on how to communicate and coordinate safety information concerning medicinal products authorised in the UK, including via direct healthcare professional communications. In addition, GVP Annex II includes templates for direct healthcare professional communications and communication plans, which should be used for UK authorised products.
UK-specific requirements in relation to the dissemination of DHPCs are outlined in a UK statutory guidance note.
Irrespective of the licensing route for a UK authorised product, marketing authorisation holders should submit both the draft and finalised versions of DHPCs and communication plans to the MHRA via vigilanceservice@mhra.gov.uk and should wait until comments are received before disseminating in the UK.
3. Call for reporting
All UK direct healthcare professional communication letters should always include a ‘Call for reporting’ section to outline national arrangements for reporting suspected adverse drug reactions.
The Template ‘Call for Reporting’ sections for UK letters should be used to encourage reporting to the Yellow Card scheme. Additional text should be considered for medicines subject to additional monitoring and for biological/biosimilar medicines and vaccines.