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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...
Sharan Murugan
Jul 30, 20232 min read
199 views
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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...
Sharan Murugan
Jul 17, 20231 min read
26 views
0 comments
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...
Sharan Murugan
Jul 2, 20231 min read
33 views
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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...
Sharan Murugan
Jun 27, 20231 min read
48 views
0 comments
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...
Sharan Murugan
Jun 17, 20231 min read
81 views
0 comments
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...
Sharan Murugan
May 18, 20232 min read
44 views
0 comments
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...
Sharan Murugan
May 13, 20232 min read
75 views
0 comments
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...
Sharan Murugan
May 13, 20232 min read
41 views
0 comments
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...
Sharan Murugan
Apr 29, 20232 min read
64 views
0 comments
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...
Sharan Murugan
Apr 9, 20231 min read
189 views
0 comments
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...
Sharan Murugan
Apr 4, 20232 min read
30 views
0 comments
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...
Sharan Murugan
Mar 27, 20231 min read
111 views
0 comments
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...
Sharan Murugan
Mar 22, 20231 min read
49 views
0 comments
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...
Sharan Murugan
Jan 31, 20231 min read
23 views
0 comments
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...
Sharan Murugan
Dec 6, 20221 min read
17 views
0 comments
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...
Sharan Murugan
Nov 19, 20221 min read
27 views
0 comments
MHRA Guidance: Licensing of Biosimilar Products
Recently (08-November-2022) the Medicines and Healthcare products Regulatory Agency (MHRA) released updated Guidance on the licensing of...
Sharan Murugan
Nov 12, 20221 min read
48 views
0 comments
UK MHRA: 150-Day Assessment for National Applications
Recently the UK's Medicines and Healthcare products Regulatory Agency (MHRA) updated their "150-day assessment for national applications...
Sharan Murugan
Nov 1, 20221 min read
167 views
0 comments
UK MHRA Guidance: Register to Manufacture, Import or Distribute Act.Sub, & Reclassify Products
The Medicines and Healthcare products Regulatory Agency (MHRA) recently updated a few guidances related to registration &...
Sharan Murugan
Oct 22, 20222 min read
29 views
0 comments
UK's MHRA Guidance: Software & AI as a Medical Device Change Programme
The Medicines and Healthcare Products Regulatory Agency (MHRA) has begun reforming medical device regulation to ensure software,...
Sharan Murugan
Oct 17, 20221 min read
37 views
0 comments