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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...

Sharan Murugan
Jun 9, 20242 min read
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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
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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...

Sharan Murugan
Feb 7, 20242 min read
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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...

Sharan Murugan
Jun 4, 20231 min read
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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...

Sharan Murugan
Feb 25, 20231 min read
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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...

Sharan Murugan
Aug 6, 20212 min read
507 views
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