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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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

UK MHRA Guidance: How to get a Parallel Import Licence in UK

Earlier today Today (13 October 2022) Medicines and Healthcare products Regulatory Agency (MHRA) updated its Guidance on Medicines:...

Sharan Murugan

Oct 13, 20221 min read

MHRA Guidance: Export Drugs & Medicine, Active substances Manufactured in GB for use in EEA & NI

The Medicines and Healthcare products Regulatory Agency (MHRA) recently updated a couple of guidances related to Exporting active...

Sharan Murugan

Oct 11, 20221 min read

MHRA Guidance: Good Clinical Practice for Clinical Trials

Earlier today (27 September 2022) MHRA released updated guidance on Good clinical practice for Clinical Trials where they had updated...

Sharan Murugan

Sep 27, 20221 min read

UK MHRA Guidance: The Northern Ireland MHRA Authorised Route (NIMAR)

The UK MHRA released this updated guidance today and added a section on 'Advertising and promotions' to Northern Ireland MHRA Authorised...

Sharan Murugan

Sep 20, 20221 min read