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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...
Sharan Murugan
Mar 20, 20242 min read
25 views
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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...
Sharan Murugan
Mar 13, 20241 min read
30 views
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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,...
Sharan Murugan
Mar 7, 20242 min read
70 views
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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...
Sharan Murugan
Mar 2, 20242 min read
21 views
0 comments
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...
Sharan Murugan
Jan 18, 20242 min read
102 views
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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...
Sharan Murugan
Jan 16, 20242 min read
51 views
0 comments
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...
Sharan Murugan
Jan 5, 20242 min read
213 views
0 comments
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...
Sharan Murugan
Jan 2, 20241 min read
37 views
0 comments
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...
Sharan Murugan
Dec 27, 20232 min read
59 views
0 comments
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...
Sharan Murugan
Dec 5, 20232 min read
136 views
0 comments
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...
Sharan Murugan
Dec 3, 20231 min read
20 views
0 comments
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...
Sharan Murugan
Nov 19, 20232 min read
198 views
0 comments
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...
Sharan Murugan
Nov 7, 20231 min read
44 views
0 comments
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...
Sharan Murugan
Oct 25, 20231 min read
47 views
0 comments
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...
Sharan Murugan
Oct 21, 20231 min read
62 views
0 comments
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...
Sharan Murugan
Oct 14, 20232 min read
24 views
0 comments
MHRA Guidance: The Northern Ireland MHRA Authorised Route (NIMAR)
On 29 September 2023 UK's Medicines and Healthcare Products Regulatory Agency (MHRA) released updated guidance on "The Northern Ireland...
Sharan Murugan
Oct 1, 20231 min read
61 views
0 comments
MHRA MD Guidance: Innovative Devices Access Pathway (IDAP) & How to Notify Clinical Investigation
Recently the UK's Medicines and Healthcare Products Regulatory Agency (MHRA) released updated guidance on "The Innovative Devices Access...
Sharan Murugan
Sep 25, 20232 min read
25 views
0 comments
UK MHRA: Guidance on International Recognition Procedure
Recently the UK's Medicines and Healthcare Products Regulatory Agency (MHRA) released a guidance on "International Recognition Procedure"...
Sharan Murugan
Sep 10, 20231 min read
80 views
0 comments
UK MHRA: Guidance on Renewing Marketing Authorisations & Implementation of Med Dev. Future Regime
Guidance on Renewing Marketing Authorisations Recently (28, July 2023) the UK's Medicines and Healthcare Products Regulatory Agency...
Sharan Murugan
Jul 30, 20231 min read
74 views
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