Mhra Submission Portal

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Updated: April 26, 2022

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Mhra.gov.uk

Most Visited Official Pages

Yellow Card | Making medicines and medical..
MHRA - Home
Medicines and Healthcare products Regulatory..

Social Handles

FAQs

1

How do I submit to MHRA?

To register for ICSR Submissions, you should visit the ICSR Submissions, portal select the 'Request company account' option, and follow the process outlined in the user reference guide . On receipt of your registration request, the MHRA will aim to complete your registration within 5 working days.
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How do I submit regulatory data through MHRA submissions?

You can also email submissions@mhra.gov.uk with urgent questions. Alternatively, contact your Trade Association by emailing: Association of the British Pharmaceutical Industry (ABPI): regulatory@abpi.org.uk. British Generic Manufacturers Association (BGMA): info@britishgenerics.co.uk.
3

How do I submit DSUR to MHRA?

You must submit your DSUR using MHRA Submissions via the Human Medicines Tile. Please select 'Development Safety Update Report' as the Regulatory Activity and 'Original Submission' from the Regulatory sub activity dropdown list.
4

How long is MHRA registration?

new applications typically take 90 working days to process.
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What do the MHRA do?

The MHRA is an executive department of the Department of Health and Social Care and is the body that regulates medicines, medical devices and blood components for transfusion in the UK.
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What does MHRA stand for in UK?

Medicines and Healthcare products Regulatory Agency
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How can you send information to the MHRA?

The MHRA is responsible for detecting and managing safety signals, in regards to UK products. In line with GVP IX requirements, standalone notifications of signals should be sent to the MHRA (signalmanagement@mhra.gov.uk).
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How do I contact the MHRA?

For general queries about the MHRA, you can also call the MHRA Customer Service Line on 0203 080 6000 (9am to 5pm Monday to Friday).
2. Www.gov.uk

Register to make submissions to the MHRA - GOV.UK

https://www.gov.uk/guidance/register-to-make-submissions-to-the-mhra

Registering for the MHRA Gateway ... Once you have completed registration for MHRA Submissions, MHRA Submissions company administrators can register to send both ...

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