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![Swiss Medic: Guidances on Varaiations, Temporary Authorisation, Meetings for Applicants and Time Limits for Authorisation](https://static.wixstatic.com/media/nsplsh_6d31487134696250397263~mv2.jpg/v1/fill/w_399,h_300,fp_0.50_0.50,q_90,enc_auto/nsplsh_6d31487134696250397263~mv2.jpg)
Sharan Murugan
- Jun 9
- 2 min
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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![UK MHRA Guidance: Applying for a Variation to a Marketing Authorisation](https://static.wixstatic.com/media/6516fb_cd862365f3374ca1a41f1b1ec9182bad~mv2.png/v1/fill/w_399,h_300,fp_0.50_0.50,q_95,enc_auto/6516fb_cd862365f3374ca1a41f1b1ec9182bad~mv2.png)
Sharan Murugan
- Apr 22
- 2 min
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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![Swissmedic Guidance: Navigating Variations, Product Information, and Electronic ICSRs through PV Gateway](https://static.wixstatic.com/media/nsplsh_3650334f705144624c3359~mv2.jpg/v1/fill/w_399,h_300,fp_0.50_0.50,q_90,enc_auto/nsplsh_3650334f705144624c3359~mv2.jpg)
Sharan Murugan
- Feb 7
- 2 min
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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![SwissMedic Guidance on Fast-Track Authorisation, Temporary Authorisation and Variations & Extensions](https://static.wixstatic.com/media/6516fb_14978bc2ad8e460a94a452f0a9fa669a~mv2.jpg/v1/fill/w_399,h_300,fp_0.50_0.50,q_90,enc_auto/6516fb_14978bc2ad8e460a94a452f0a9fa669a~mv2.jpg)
Sharan Murugan
- Jun 4, 2023
- 1 min
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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![Finland's FIMEA: New/Updated (EU) MDCG Guidances to support Medical Device Operators](https://static.wixstatic.com/media/nsplsh_0865fccaf4164f6586b04b94ec5c42b7~mv2.jpg/v1/fill/w_399,h_300,fp_0.50_0.50,q_90,enc_auto/nsplsh_0865fccaf4164f6586b04b94ec5c42b7~mv2.jpg)
Sharan Murugan
- Feb 25, 2023
- 1 min
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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