Regulatory Blog

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Jun 92 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...

Apr 222 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...

Feb 72 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...

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...

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...

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...