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Sharan Murugan
Dec 21, 20242 min read
UK MHRA: Guidance on the Licensing of Biosimilar Products
The Medicines and Healthcare products Regulatory Agency (MHRA)Â has updated its guidance on the " Licensing of Biosimilar Products "Â in...
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Sharan Murugan
Dec 15, 20242 min read
UK MHRA Guidance: Applying for a Licence to Market a Medicine in the UK
The Medicines and Healthcare Products Regulatory Agency (MHRA) Â has published updated guidance " Applying for a Licence to Market a...
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Sharan Murugan
Sep 28, 20242 min read
UK MHRA: Guidance on Applying for a Manufacturer or Wholesaler of Medicines Licence
Yesterday (27 September 2024) the UK's Medicines and Healthcare Products Regulatory Agency (MHRA) released updated guidance on " Applying...
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Sharan Murugan
Apr 22, 20242 min read
Swiss Medic: Guidance on GMP compliance by Foreign Manufacturers & Application Establishment Licence for Medicinal Products
This Monday (24 April 2024) Swissmedic, updated its guidance on "GMP compliance by Foreign Manufacturers" and "Application establishment...
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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...
85 views0 comments
Sharan Murugan
Mar 25, 20242 min read
UK MHRA: Guidance on Regulation of devices in Northern Ireland & Apply for Manufacturer or Wholesaler of Medicines Licences
Earlier today (25 March 2025) UK's Medicines and Healthcare Products Regulatory Agency (MHRA) released updated guidance on "Apply for...
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Sharan Murugan
Mar 20, 20242 min read
UK MHRA: Guidance on Licence to Market, Export Drugs, Reclassifing Medicine s & Notifying about a Clinical Investigation for a Medical Device
This week the Medicines and Healthcare Products Regulatory Agency (MHRA) updated multiple guidelines related to medicine and medical...
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Sharan Murugan
Mar 2, 20242 min read
UK MHRA Guidance: Navigating on Applying for a Licence to Market a Medicine
Last Wednesday (28 February 2024) UK's Medicines and Healthcare Products Regulatory Agency (MHRA) released updated guidance on "Apply for...
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Sharan Murugan
Nov 19, 20231 min read
South Africa's (SAPHRA): Questions And Answers Licensing Of Medical Device Establishments
Last Friday (17 November 2023) the South African Health Products Regulatory Authority (SAPHRA) released updated guidance on "Guideline On...
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Sharan Murugan
Oct 21, 20231 min read
UK MHRA Guidance: Apply for a Licence to Market a Medicine in the UK
Last Thursday (19 October 2023) UK's Medicines and Healthcare Products Regulatory Agency (MHRA) released updated guidance on "Apply for a...
53 views0 comments
Sharan Murugan
Jul 12, 20231 min read
Malaysia’s NPRA: Guideline on Manufacturer’s, Import, Wholesaler’s Licenses & Nitrosamine Impurity
Today (12 July, 2023) the National Pharmaceutical Regulatory Agency (NPRA) of Malaysia published a guideline on "Application of...
113 views0 comments
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
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 9, 20222 min read
Philippines FDA: Guidelines on the Unified Licensing Requirements
Philippines FDA (on 04-October-2022) released the draft “Revised Guidelines on the Unified Licensing Requirements and Procedures of the...
195 views0 comments
Sharan Murugan
Sep 17, 20221 min read
Philippines FDA Guidance: License to Operate (LTO) Application of Retailers of Medical Devices
On 13 September 2022, the Philippines FDA released updated guidelines on the Use of the Food and Drug Administration eServices Portal...
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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...
340 views0 comments
Sharan Murugan
Jun 16, 20221 min read
Malaysia’s - DRAFT GUIDANCE DOCUMENT LICENSING FOR ESTABLISHMENT
Malaysia’s Medical Device Authority (MDA) & Malaysia’s National Pharmaceutical Regulatory Agency (NPRA) has updated guidance updates...
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Sharan Murugan
Oct 12, 20211 min read
Philippines FDA: Guidelines on the Licensing of Retailers of Medical Devices
On 8 May 2020, the Philippines Department of Health (DOH) entitled “Revised Guidelines on the Unified Licensing Requirements and...
132 views0 comments