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Sharan Murugan
Oct 1, 20231 min read
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...
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Sharan Murugan
Sep 25, 20232 min read
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...
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Sharan Murugan
Sep 9, 20231 min read
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"...
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Sharan Murugan
Jul 30, 20231 min read
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...
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Sharan Murugan
Jul 30, 20232 min read
UK MHRA: Guidance on Labelling & Packaging of Medicinal Products - Windsor Framework
On 27 July 2023 UK's Medicines and Healthcare Products Regulatory Agency (MHRA) released updated guidance on "Labelling and packaging of...
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Sharan Murugan
Jul 17, 20231 min read
MHRA Med Dev Guidance: In-Vitro Diagnostic Medical Devices on Legislation
Earlier today (17 July, 2023) UK's Medicines and Healthcare Products Regulatory Agency (MHRA) released updated guidance on "The...
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Sharan Murugan
Jul 2, 20231 min read
UK MHRA MD Guidance: Borderlines with Medical Devices & Other Products in Great Britain
Yesterday(01 July 2023) UK's Medicines and Healthcare Products Regulatory Agency (MHRA) released updated guidelines on the "Borderlines...
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Sharan Murugan
Jun 27, 20231 min read
UK MHRA Guidance: Clinical Trials for Medicines: Apply for Authorisation in the UK
Yesterday (27 June 2023) UK's Medicines and Healthcare Products Regulatory Agency (MHRA) released updated guidance on "Clinical Trials...
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Sharan Murugan
Jun 17, 20231 min read
MHRA Guidance: 150-Day Assessment for National Applications & Parallel Import Licence
Recently (09 May 2023) UK's Medicines and Healthcare Products Regulatory Agency (MHRA) released updated guidance on the "150-Day...
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Sharan Murugan
May 18, 20232 min read
UK MHRA: Med Dev Guidance on "Off-Label Use","Virtual Mfg." "Legal Requirements" & "Approved Bodies"
UK's Medicines and Healthcare Products Regulatory Agency (MHRA) this week (16,17 May 2023) released updated multiple guidances related...
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Sharan Murugan
May 13, 20232 min read
UK MHRA: Guidance on Qualified Person responsible for QPPV & PSMF
Last Thursday (11 May 2023) UK's Medicines and Healthcare Products Regulatory Agency (MHRA) released updated "Guidance on the qualified...
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Sharan Murugan
May 13, 20232 min read
UK MHRA Guidance: Notifying MHRA on a Clinical Investigation for a Medical Device
Last Thursday (11 May 2023) UK's Medicines and Healthcare Products Regulatory Agency (MHRA) released updated Guidance on "Notify the MHRA...
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Sharan Murugan
Apr 29, 20232 min read
MHRA Guidance: Registration & Regulating Medical Devices in UK
Yesterday (28 April 2023) UK's Medicines and Healthcare Products Regulatory Agency (MHRA) released updated guidance on "Regulating...
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Sharan Murugan
Apr 9, 20231 min read
UK MHRA: Guidance on Good Clinical Practice for Clinical Trials
The Medicines and Healthcare Products Regulatory Agency (MHRA) recently (06 April 2023) released updated guidance on "Good Clinical...
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Sharan Murugan
Apr 4, 20232 min read
UK MHRA: MHRA Fees 2023 & Guidance on How to Draft a Direct Health Care Professional Communication
Statutory guidance on MHRA fees A new statutory fee for MHRA services was introduced on April 1, 2023, by the Medicines and Healthcare...
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Sharan Murugan
Mar 27, 20231 min read
UK MHRA: Guidance on Register Medical Devices to place on the Market
Earlier today (27 March 2023) UK's Medicines and Healthcare products Regulatory Agency (MHRA) released updated guidance on "Register...
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Sharan Murugan
Mar 22, 20231 min read
UK MHRA: MD Guidance on Crafting an Intended Purpose in the Context of SaMD
Earlier today (22 March 2023) UK Medicines and Healthcare products Regulatory Agency released updated guidance on "Crafting an intended...
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Sharan Murugan
Jan 31, 20231 min read
MHRA Guidance: Innovative Licensing and Access Pathway (updation)
The UK Medicines and Healthcare Products Regulatory Agency (MHRA) has updated its guidance information on the Innovative Licensing and...
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Sharan Murugan
Dec 6, 20221 min read
UK MHRA: MD Guidance - Register Medical Devices to Place on the Market
Earlier today UK Medicines and Healthcare products Regulatory Agency released an updated guidance on "Register medical devices to place...
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Sharan Murugan
Nov 19, 20221 min read
UK MHRA: Guidance on EC Decision Reliance Procedure Extended till 31 Dec, 2023 & Nitrosamine Risk
On 18th November 2022 the UK's Medicines and Healthcare products Regulatory Agency released its updated guidance on the "European...
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