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Sharan Murugan
Dec 21, 20242 min read
UK MHRA Guidance: Variations to Marketing Authorisations (MAs)
The UK Medicines and Healthcare products Regulatory Agency (MHRA) has published (20 December 2024) updated guidance " Variations to...
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Sharan Murugan
Nov 16, 20242 min read
UK MHRA Guidance: How Marketing Authorisation Applications referred under Article 29 are Handled
The UK MHRA updated its Guidance on " How Marketing Authorisation Applications referred under Article 29 are Handled " and outlines the...
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Sharan Murugan
Oct 6, 20242 min read
Switzerland's Swiss Medic Guidance: Transfer of Marketing Authorisation
Recently (01 October, 2024) Swissmedic released an updated guidance " Transfer of Marketing Authorisation "Â which provides detailed...
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Sharan Murugan
Apr 22, 20242 min read
UK MHRA Guidance: Applying for a Variation to a Marketing Authorisation
Yesterday (22 April 2024) the UK Medicines and Healthcare products Regulatory Agency (MHRA) updated its guidance "Medicines: apply for a...
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Sharan Murugan
Mar 29, 20242 min read
Ireland HPRA: Guide to Renewal of Marketing Authorisations –Human Medicines
Irelands Health Products Regulatory Authority (HPRA) released guidance on "Guide to Renewal of Marketing Authorisations - Human...
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Sharan Murugan
Mar 13, 20241 min read
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...
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Sharan Murugan
Nov 18, 20232 min read
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...
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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
Jun 27, 20231 min read
EMA Guidance: Procedural Advice on Publication on Withdrawals of Applications related to MA
Today (27 June 2023), the European Medicines Agency released updated guidance on "Procedural Advice on Publication of Information on...
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Sharan Murugan
May 7, 20231 min read
Swiss Medic: Guidance on Transfer of Marketing Authorisation
Swissmedic, the Swiss Agency for Therapeutic Products, published an updated guidance document on (3 May 2023) the "Transfer of Marketing...
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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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