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Sharan Murugan
Jun 9, 20242 min read
Swiss Medic: Guidances on Varaiations, Temporary Authorisation, Meetings for Applicants and Time Limits for Authorisation
Swissmedic, the Swiss Agency for Therapeutic Products, is responsible for ensuring that only high-quality, safe, and effective medical...
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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
Feb 7, 20242 min read
Swissmedic Guidance: Navigating Variations, Product Information, and Electronic ICSRs through PV Gateway
Yesterday (06 February 2024) Switzerland's Swissmedic released updated guidance on "Electronic exchange of ICSRs through PV Gateway", and...
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Sharan Murugan
Jun 4, 20231 min read
SwissMedic Guidance on Fast-Track Authorisation, Temporary Authorisation and Variations & Extensions
Last week Swissmedic, the Swiss Agency for Therapeutic Products updated and released 3 Important guidances and forms. 1. Guidance on...
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Sharan Murugan
Feb 25, 20231 min read
Finland's FIMEA: New/Updated (EU) MDCG Guidances to support Medical Device Operators
On 16 February 2023, the European Parliament approved the European Commission's proposal for amending the EU's Medical Device regulatory...
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Sharan Murugan
Aug 6, 20212 min read
Guidance on Variations, Extensions, Doc Protections, Form & Criteria Annex – Swissmedic -HMV4
Swismedic released multiple Guidance documents on 1st august, 2021 and are as follows 1. Guidance document Variations and extensions HMV4...
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