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UK MHRA: Guidance for Established Medicines -Marketing Authorisation Application Changes
The regulatory landscape for pharmaceuticals is constantly evolving, and the UK Medicines and Healthcare products Regulatory Agency...

Sharan Murugan
Apr 12 min read
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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...

Sharan Murugan
Dec 21, 20242 min read
235 views
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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...

Sharan Murugan
Nov 16, 20242 min read
26 views
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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...

Sharan Murugan
Oct 6, 20242 min read
40 views
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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...

Sharan Murugan
Apr 22, 20242 min read
139 views
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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...

Sharan Murugan
Mar 29, 20242 min read
16 views
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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...

Sharan Murugan
Mar 13, 20241 min read
30 views
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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...

Sharan Murugan
Nov 19, 20232 min read
196 views
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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...

Sharan Murugan
Jul 30, 20231 min read
74 views
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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...

Sharan Murugan
Jun 27, 20231 min read
328 views
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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...

Sharan Murugan
May 7, 20231 min read
52 views
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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...

Sharan Murugan
Jul 23, 20222 min read
39 views
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