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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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Sharan Murugan
Nov 12, 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...
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Sharan Murugan
Nov 1, 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...
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Sharan Murugan
Oct 22, 20222 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 &...
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Sharan Murugan
Oct 17, 20221 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,...
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Sharan Murugan
Oct 13, 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:...
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Sharan Murugan
Oct 11, 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...
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Sharan Murugan
Sep 27, 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...
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Sharan Murugan
Sep 20, 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...
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Sharan Murugan
Sep 7, 20221 min read
UK MHRA's Guidance: Software Applications (apps)
Recently the MHRA updated its Medical devices: Software Applications (apps) guidance, which provides information on when software...
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Sharan Murugan
Aug 17, 20221 min read
UK MHRA's: Apply for a Parallel Import Licence (Guidance Update)
Today (17 August 2022) MHRA updated its Guidance on "Medicines: apply for a parallel import licence" The guidance in general details...
343 views0 comments
Sharan Murugan
Aug 9, 20221 min read
UK MHRA Guidance on: Manage your authorisation & Report Safety Issues
Today (9 August 2022) MHRA updated their Guidance on Clinical trials for medicines to manage authorisation, and report safety issues. The...
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Sharan Murugan
Aug 4, 20221 min read
UK MHRA Guidance: Medicines: How to Reclassify your Product
Today (August 4, 2022) UK Medicines and Healthcare products Regulatory Agency (MHRA) updated its guidance for the industry, “Guidance:...
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Sharan Murugan
Jul 31, 20221 min read
UK updated Guidance: Register Medical Devices to Place on the Market
Earlier this Thursday the Medicines and Healthcare products Regulatory Agency (MHRA) updated its guidance on how to register your medical...
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Sharan Murugan
Jul 23, 20222 min read
UK MHRA's -Updated Guidance: How to Apply for Authorisation in the UK
Clinical trials for Medicines: Apply for Authorisation in the UK (18 July 2022) This updated guidance will detail how to apply for a...
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Sharan Murugan
Mar 23, 20221 min read
UK MHRA: Guidance on "Advertise your Medicines"
The MHRA on 17-March-2022 updated its Guidance on Advertise your medicines which details how to comply with the requirements on promoting...
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Sharan Murugan
Mar 13, 20221 min read
UK (MHRA) Project Orbis Guidance Update & New Guidance on Dialysis
Project Orbis aims to review and approve promising cancer treatments to help patients access treatment faster. MHRA recently added...
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Sharan Murugan
Mar 6, 20221 min read
MHRA adds Health Technology Assessments (HTA) Tool Details to ILAP Guide
MHRA, the UK Medicines and Healthcare Products Regulatory Agency has updated its guidance information on the Innovative Licensing and...
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Sharan Murugan
Jan 23, 20221 min read
Electronic Application Form and Cover Letter Tool - UK MHRA
On January 20, 2022, the UK MHRA released guidance on how to complete your Electronic Application Form (eAF) and Cover Letter. This form...
300 views0 comments
Sharan Murugan
Jan 16, 20221 min read
UK Guidance on Clinical Trials: How to Apply for Authorization
UK MHRA updated its guidance on How to apply for a clinical trial including eligibility, phases, model IMPDs, costs, and how to make...
40 views0 comments