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Sharan Murugan
Apr 22, 20242 min read
UK MHRA Guidance: Applying for a Variation to a Marketing Authorisation
Yesterday (22 April 2024) the UK Medicines and Healthcare products Regulatory Agency (MHRA) updated its guidance "Medicines: apply for a...
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Sharan Murugan
Apr 16, 20242 min read
UK MHRA: Rolling Review for MAA and 150-Day Assessment for National Applications
Earlier today (16 April 2024) Medicines and Healthcare Products Regulatory Agency (MHRA) updated its guidance on "Rolling Review for...
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Sharan Murugan
Apr 13, 20242 min read
UK MHRA Guidance: Borderlines with Medical Devices & Other Products in Great Britain
The UK Medicines and Healthcare Products Regulatory Agency (MHRA) updated its guidance "Borderlines with Medical Devices & Other Products...
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Sharan Murugan
Mar 25, 20242 min read
UK MHRA: Guidance on Regulation of devices in Northern Ireland & Apply for Manufacturer or Wholesaler of Medicines Licences
Earlier today (25 March 2025) UK's Medicines and Healthcare Products Regulatory Agency (MHRA) released updated guidance on "Apply for...
31 views0 comments
Sharan Murugan
Mar 20, 20242 min read
UK MHRA: Guidance on Licence to Market, Export Drugs, Reclassifing Medicine s & Notifying about a Clinical Investigation for a Medical Device
This week the Medicines and Healthcare Products Regulatory Agency (MHRA) updated multiple guidelines related to medicine and medical...
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Sharan Murugan
Mar 13, 20241 min read
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...
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Sharan Murugan
Mar 7, 20242 min read
UK MHRA: Guidance on Packaging, Labelling and Patient Information Leaflets
Earlier today (08 March 2024) Medicines and Healthcare Products Regulatory Agency (MHRA) updated its "Guidance on Medicines: Packaging,...
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Sharan Murugan
Mar 2, 20242 min read
UK MHRA Guidance: Navigating on Applying for a Licence to Market a Medicine
Last Wednesday (28 February 2024) UK's Medicines and Healthcare Products Regulatory Agency (MHRA) released updated guidance on "Apply for...
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Sharan Murugan
Jan 18, 20242 min read
MHRA Guidance: MAH Submission of Nitrosamine Risk Evaluation, Risk Assessment and Confirmatory Testing
Nitrosamines have become a significant concern in the pharmaceutical industry due to their potential carcinogenicity. In response to this...
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Sharan Murugan
Jan 16, 20242 min read
MHRA Guidance: Notify the MHRA about a Clinical Investigation for a Medical Device
Earlier today (17 July, 2024) UK's Medicines and Healthcare Products Regulatory Agency (MHRA) released updated guidance on "Notify the...
49 views0 comments
Sharan Murugan
Jan 5, 20242 min read
UK MHRA: Guidance on 150-Day Assessment for National Applications for Medicines
Earlier today (05 January 2024) UK's Medicines and Healthcare Products Regulatory Agency (MHRA) released updated guidance on "150-day...
118 views0 comments
Sharan Murugan
Jan 2, 20241 min read
UK MHRA: Guidance on Operational Information Sharing
Earlier today (02 January 2024) UK's Medicines and Healthcare Products Regulatory Agency (MHRA) released updated guidance on "Operational...
35 views0 comments
Sharan Murugan
Dec 27, 20232 min read
UK MHRA: Guidance on Submitting Changes to Labelling and Patient Information Leaflets
On 22nd December 2023, the Medicines and Healthcare Products Regulatory Agency (MHRA) updated its guidance on Medicines "Submitting...
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Sharan Murugan
Dec 5, 20232 min read
UK MHRA Guidance: Apply for a Parallel Import Licence
Earlier today (05 December 2023) Medicines and Healthcare Products Regulatory Agency (MHRA) updated its guidance on Medicines: "Apply for...
117 views0 comments
Sharan Murugan
Dec 3, 20231 min read
UK MHRA: Guidance on Register Medical Devices to Place on the Market
Last Friday on 1st December 2023 UK's Medicines and Healthcare Products Regulatory Agency (MHRA) released updated guidance on "Register...
17 views0 comments
Sharan Murugan
Nov 18, 20232 min read
UK MHRA: Guidance on Change of Ownership: Marketing Authorisation Process
Last Friday (17 November 2023) UK's Medicines and Healthcare Products Regulatory Agency (MHRA) released updated guidance on "Medicines...
144 views0 comments
Sharan Murugan
Nov 7, 20231 min read
MHRA Guidance: Common Issues Identified during Clinical Trial Applications
Yesterday (06 November 2023) the UK's Medicines and Healthcare Products Regulatory Agency (MHRA) released updated guidance on "Common...
38 views0 comments
Sharan Murugan
Oct 25, 20231 min read
UK MHRA: Guidance on Software and Artificial Intelligence (AI) as a Medical Device
Earlier today (25 October 2023) UK's Medicines and Healthcare Products Regulatory Agency (MHRA) released updated Guidance on "Software...
31 views0 comments
Sharan Murugan
Oct 21, 20231 min read
UK MHRA Guidance: Apply for a Licence to Market a Medicine in the UK
Last Thursday (19 October 2023) UK's Medicines and Healthcare Products Regulatory Agency (MHRA) released updated guidance on "Apply for a...
53 views0 comments
Sharan Murugan
Oct 14, 20232 min read
UK MHRA: Clinical Trials for Medicines: Apply for Authorisation in the UK
Recently (12 October 2023) UK's Medicines and Healthcare Products Regulatory Agency (MHRA) released updated guidance on "Clinical Trials...
15 views0 comments