The Medicines and Healthcare products Regulatory Agency (MHRA) is pleased to announce that the RegulatoryConnect portal and its first self-serve tools will be available to customers from Monday 25 March 2024.
About the RegulatoryConnect portal
The RegulatoryConnect portal will provide greater transparency and visibility for regulatory assessments and timelines. This first release will let you log-in using existing MHRA submission credentials and access a common portal, where you will be able to:
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track the status of your application and see which stage it is at. This will be known as ‘Track My Case’.
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view live authorisation details, including the status and key data about your existing licences. This will be known as ‘See My Data’.
These services are available to those who have made applications to the MHRA on behalf of their organisation.
Future functionality and features will be added to RegulatoryConnect later in the year, including the ability to submit applications and variations to the MHRA through the service.
RegulatoryConnect, formerly known as the Regulatory Management System, is a new IT system being developed by the Medicines and Healthcare products Regulatory Agency (MHRA) to modernise its existing regulatory IT systems and make our regulatory services more streamlined.
RegulatoryConnect will help enable predictable healthcare access to safe and effective medical products. All new product licences, variations, inspections, and process licences will be efficiently handled, maximising the use of self-service for low-risk decisions.
More information on support, guidance and what you need to get ready to use this service will be available soon. Please continue to keep an eye out for MHRA emails about RegulatoryConnect in the coming weeks.
Thank you,
The Medicines and Healthcare products Regulatory Agency
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