UK MHRA: Guidance on Established Medicines Marketing Authorisation Application Process Changes

The UK Medicines and Healthcare products Regulatory Agency (MHRA) updated its guidance "Established Medicines Marketing Authorisation Application Process Changes" that details on the application process for changes to the marketing authorisation (MA) of established medicines.

These guidelines are crucial for ensuring that changes to authorised medicines are implemented efficiently while maintaining safety, efficacy, and quality standards.

A new process for applications for marketing authorisations is being introduced for "Established Medicines" starting on 1 March 2024.

The term "Established Medicines" covers both products that are not new active substances and line extensions for new active substances. The changes apply specifically to 'chemical' products and exclude 'biosimilars'.

The approaches set out below will be adopted for all applications, until further notice, and will be reviewed after three months.

1. Revised process for applications received and where assessment has not started

2. Revised process for applications which are already under assessment or have received a “Request for Further Information”

The key changes are as follows:

• Incomplete applications will not be processed.

• Only one Request for Further Information (RFI) will be sent.

• Applicants will be asked to submit a pre-populated template for the Lay Summary for the UK Public Assessment Report (UKPAR) following approval.

The MHRA's Regulatory Information Service (RIS) serves as the main point of contact for marketing authorisation holders and their representatives.

For more information and specific details on the application process changes, please refer to the MHRA's official guidance document.