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Swiss Medic: Biosimilar Authorisation Guidance
Swissmedic, the Swiss Agency for Therapeutic Products, published an updated guidance on (26 November 2023) the "Guidance document...
Sharan Murugan
Nov 26, 20232 min read
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Switzerland's SwissMedic: Guidance on Formal Requirements
On 15 November 2023, Switzerland's Swissmedic released an updated guidance on "Formal Requirements" which serves as a resource for...
Sharan Murugan
Nov 15, 20232 min read
39 views
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Switzerland's SwissMedic: Harmonisation of the SwissGMP/GDP Inspection System
Yesterday (20 July 2023) Switzerland's Swissmedic released an updated guidance on "Harmonisation of the SwissGMP/GDP Inspection System"...
Sharan Murugan
Jul 21, 20232 min read
48 views
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Switzerland's SwissMedic: Guidance on Information of PSURs/PBRER submission
On 21 June 2023, Switzerland's Swissmedic released an updated guidance on "Information of PSURs/PBRER Submission" which describes the...
Sharan Murugan
Jun 25, 20231 min read
116 views
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Switzerland's SwissMedic: Guidance on Authorisation Biosimilar
Yesterday (21 June 2023) Switzerland's Swissmedic released an updated guidance on "Authorisation Biosimilar" which specifies the...
Sharan Murugan
Jun 22, 20231 min read
36 views
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SwissMedic Guidance: Orphan Drug, New Active Substance & Prior Notification
Swissmedic recently (02 June 2023) released multiple important guidelines that have captivated the audience and generated significant...
Sharan Murugan
Jun 4, 20232 min read
42 views
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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
34 views
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Swiss Medic Guidance: Minimising the Risk of TSE and Authorisation of Radiopharmaceuticals
Swissmedic, the Swiss Agency for Therapeutic Products, published an updated guidance document on (26 May 2023) the "Guidance document...
Sharan Murugan
May 28, 20232 min read
34 views
0 comments
Switzerland's Swissmedic: Med Dev Guidance on Export Certificates and Service Agreement
Yesterday (23 May 2023) Switzerland's Swissmedic released two updated guidances one is "Export Certificates" guidance and another one is...
Sharan Murugan
May 23, 20232 min read
33 views
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Swiss Medic: Guidance on Transfer of Marketing Authorisation
Swissmedic, the Swiss Agency for Therapeutic Products, published an updated guidance document on (3 May 2023) the "Transfer of Marketing...
Sharan Murugan
May 7, 20231 min read
49 views
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Swiss Medic: Information sheet on Clinical Investigations with Medical Devices
Recently (13-April-2023) Switzerland's Swissmedic released an updated Information sheet document for "Information sheet on Clinical...
Sharan Murugan
Apr 17, 20231 min read
14 views
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Swissmedic: Guidance for Requesting Product Certificates (Certificate of a Pharmaceutical Product)
Earlier today Switzerlands Swissmedic released an updated guidance document for "Requesting Product Certificates - Certificate of a...
Sharan Murugan
Mar 20, 20231 min read
31 views
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Swissmedic: eCTD v4.0 Implementation Guide published
Earlier today (17 March 2023) Switzerland's SwissMedic released published the "Implementation Guide for eCTD v4.0" and the implementation...
Sharan Murugan
Mar 17, 20231 min read
169 views
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Swissmedic Guidance: Requesting Certificate of a Pharmaceutical Product (CPP)
Earlier today (13 March 2023) Switzerland's SwissMedic released an updated "Guidance document for requesting product certificates (CPP)"...
Sharan Murugan
Mar 13, 20231 min read
97 views
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Swiss Medic Guidance: Product Information & Packaging for Human Medicinal Products
Recently (01 march, 2023) Swissmedic released an updated guidance document on "Product information for human medicinal products" and...
Sharan Murugan
Mar 4, 20231 min read
47 views
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Swissmedic Guidance: Temporary Authorisation to Use an Unauthorised Medicinal Product
A temporary authorisation of use of an unauthorised medicinal product under restricted conditions can be granted to the sponsor of a...
Sharan Murugan
Dec 27, 20221 min read
41 views
0 comments
Swissmedic: Guideline Amendments Clinical Trials & Clinical Trial Application Dossier
Earlier today (23-November-2022) Swissmedic released two updated guidelines "Guideline Amendments Clinical Trials" and "Clinical Trial...
Sharan Murugan
Nov 23, 20221 min read
46 views
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Swissmedic Guidance: Medicinal Product Name HMV4
On 28 September 2022 Swissmedic updated and released their "Guidance document Medicinal product name HMV4 ". This guidance document...
Sharan Murugan
Sep 30, 20221 min read
57 views
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Swissmedic Guidance: eDok Submission Update
Swissmedic on Thursday released an updated guidance document on the eDok submission which as included new templates with minor other...
Sharan Murugan
Sep 17, 20221 min read
45 views
0 comments
SwissMedic Guidance: On Export Certificates
On 1-September, 2022 Swissmedic released the updated guidance on " Guidance document On Export Certificates". Swissmedic issues export...
Sharan Murugan
Sep 4, 20221 min read
13 views
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