On 22nd December 2023, the Medicines and Healthcare Products Regulatory Agency (MHRA) updated its guidance on Medicines "Submitting changes to labelling and patient information leaflets" which explains on how to submit changes to labelling and patient information leaflets to MHRA.
In the realm of pharmaceuticals, ensuring that labelling and patient information leaflets (PILs) accurately reflect a product's characteristics and usage is critical for patient safety.
The MHRA allows marketing authorization holders (MAHs) to self-certify most changes to labelling and PILs that are not linked to the summary of product characteristics (SmPC). This self-certification process involves the MAHs making the necessary changes and notifying the MHRA without undergoing formal assessment.
In this guidance document, changes to packaging components are addressed for all medicines except parallel imported products, traditional herbal products, and homoeopathic medicines.
The MHRA must be notified of most changes to labelling and/or patient information leaflets that are not connected to changes to the summary of product characteristics. The Data Assurance Quality team (DAQ) will not accept these changes as full applications for formal assessment and they cannot be submitted for formal assessment.
By these provisions, notifications to the MHRA under these provisions will be deemed "tell and do," and will be accepted within 14 days of receipt. Changes can be implemented after the MHRA accepts the notification. When submitting changes, MAHs must provide full-color mock-ups of the proposed final packaging components, including consolidated artwork files with the altered labelling elements.
To ensure the validity and quality of submissions, the MHRA conducts audits based on both random and targeted sampling of notifications. These audits serve to monitor compliance with regulatory standards and may result in outcome reports being published on the MHRA's website.