Guidance

Submitting changes to labelling and patient information leaflets

Guidance on how to submit changes to labelling and patient information leaflets to MHRA.

• From: Medicines and Healthcare products Regulatory Agency
• Published: 29 December 2014
• Last updated: 22 December 2023
  Show all updates

  1. 22 December 2023

     - Removed out of date paragraph on submitting notifications - Updated Notification of Changes to Labels and Patient Information Leaflets for Self-Certification Form.

  2. 31 December 2020

     Published a HTML version, updated to reflect the end of the transition period.

  3. 29 December 2014

     First published.

Documents

Submitting changes to labelling and patient information leaflets

HTML

Notification of Changes to Labels and Patient Information Leaflets for Self Certification Form

MS Word Document, 116 KB

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Request an accessible format

If you use assistive technology (such as a screen reader) and need a version of this document in a more accessible format, please email webupdates@mhra.gov.uk. Please tell us what format you need. It will help us if you say what assistive technology you use.

Application for changes to labels and patient information leaflets

MS Word Document, 34 KB

This file may not be suitable for users of assistive technology.

Request an accessible format

If you use assistive technology (such as a screen reader) and need a version of this document in a more accessible format, please email webupdates@mhra.gov.uk. Please tell us what format you need. It will help us if you say what assistive technology you use.

Details

Marketing authorisation holders must inform the relevant competent authority of all changes to labels and patient information leaflets which are not connected with changes to the summary of product characteristics (SPC).

This guidance sets out how to submit a change to labelling and patient information leaflets to MHRA, either for full assessment or through the notification scheme.