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Medicines Submissions to the MHRA: A Comprehensive Guide

Navigating the regulatory landscape for human medicines in the UK requires compliance with the guidelines set by the Medicines and Healthcare products Regulatory Agency (MHRA). This blog provides a detailed walkthrough on how pharmaceutical companies, clinical trial sponsors, e-cigarette producers, and brokers can register to make submissions to the MHRA.


Key Steps for Registering to Make Submissions to the MHRA

  1. Understanding the Requirements:

    1. For any regulatory submissions related to human medicines, companies need to submit directly to the MHRA using the national portals.

    2. Applications for UK or Great Britain markets must be made through MHRA's portals, whereas submissions through European procedures continue via the EU portals like CESP.

  2. Gaining Access to MHRA Submissions:

    1. Before starting, ensure that you watch the provided video demos and refer to the user reference guides available on the MHRA website.

    2. The initial registration process involves setting up an initial company administrator who will manage user permissions.

  3. User Registration Process:

    1. Initial Company Administrator: The first person to register will become the initial company administrator. This role involves adding further administrators and users within the organization.

    2. Adding Users: The administrator can add internal colleagues or third-party consultants as users. Detailed video demos and user reference guides are available to assist with this process.

  4. Multiple Legal Entities:

    1. If your organization has multiple legal entities, each should have its own company administrator.

    2. For pharmaceutical companies, this is related to the unique 5-digit MHRA company number used in product licensing.

  5. Vigilance Systems Registration:

    1. Register to use the MHRA Gateway and ICSR Submissions systems for sending and receiving individual case safety reports (ICSRs) and serious adverse events.

    2. Two short videos cover the MHRA Gateway registration process and ICSR Submissions registration process.

  6. Submitting Applications:

    1. Applications such as Marketing Authorizations, Clinical Trial Applications, and other regulatory submissions need to be managed through the MHRA's portals.

    2. Detailed user guides are available to ensure submissions are completed correctly.


User Reference Guides

  1. Gaining Access: [User Reference Guide – Gaining Access to MHRA Submissions](https://assets.publishing.service.gov.uk/media/609121018fa8f51b98b1512b/URG_Gaining_Access_to_MHRA_Submissions.pdf) (PDF, 908 KB, 20 pages).

  2. Managing Users: [User Reference Guide – Managing Users on MHRA Submissions](https://assets.publishing.service.gov.uk/media/5fedc098d3bf7f0897f246c8/Managing_users_on_MHRA_Submissions.pdf) (PDF, 540 KB, 9 pages).


Important Considerations


  • Choosing Company Administrators: Larger organizations might need multiple administrators across different departments (e.g., regulatory affairs, pharmacovigilance, clinical trials).

  • Registration Confirmation: Only the initial company administrator needs to complete the full registration process. Subsequent users will be added by the company administrator.

  • Technical Issues: For any issues with registration, user addition, or system access, contact the MHRA at submissions@mhra.gov.uk.


Submissions and Reporting

  • ICSRs and SUSARs: Follow the MHRA’s guidance for submitting individual case safety reports and serious adverse events.

  • System Downtime: The MHRA provides a business continuity plan to guide submissions during planned or unplanned downtime.


Additional Resources


Webinars and Demos:

The MHRA provides webinars and video demonstrations to help users understand the submission process.


Support Contacts:

- General inquiries: info@mhra.gov.uk

- ICSR/SUSAR process: E2B.support@mhra.gov.uk

- Trade Associations for additional support.



Conclusion


By following the steps outlined in this guide and utilizing the resources provided by the MHRA, organizations can ensure they meet regulatory requirements for submitting information related to human medicines. Proper registration and understanding of the submission portals are crucial for compliance and efficient communication with the MHRA.


For further details, visit the MHRA’s official (https://www.gov.uk/guidance/register-to-make-submissions-to-the-mhra).



Find the document attached below!

MHRA Human Medicine submissions
.pdf
Download PDF • 430KB


Submissions to the MHRA
Submissions to the MHRA


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