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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
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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
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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
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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
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Swiss Medic Guidance: Authorisation Procedures for Covid-19 Medicinal products
Yesterday (01.08.2022) the Swiss Medic updated their "Guidance document on Authorisation procedures for Covid-19 medicinal products...
Sharan Murugan
Aug 2, 20221 min read
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SwissMedic updated Guidance: Packaging for Human Medicinal Products
Recently on 14-July 2022, SwissMedic updated their "Packaging for human Medicinal Products" guidance. This guidance document explains how...
Sharan Murugan
Jul 24, 20221 min read
35 views
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Swissmedic - Guidance on known Active Pharmaceutical Substance & Time limits for Authorisation
Guidance Document Authorisation of the human medicinal product with known Active Pharmaceutical Substance Medicinal products with known...
Sharan Murugan
Jun 7, 20222 min read
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SwissMedic - Technical Requirements for the Submission of Clinical Trial Application
On 4-May-2022 the Swissmedic shared information on the technical requirements for submitting applications for clinical trials for...
Sharan Murugan
May 13, 20221 min read
21 views
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Guidance on Renewal & Discontinuation of Authorisation on change of Status -Swiss Medic
This guidance document describes the rules that apply to the renewal or discontinuation of authorisation, how these rules are to be...
Sharan Murugan
Mar 24, 20221 min read
12 views
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SwissMedic Guidance on Packaging for Human Medicinal Products
On 11-March-2022, SwissMedic released updated guidance on "Packaging for Human Medicinal Products". The purpose of this document is to...
Sharan Murugan
Mar 13, 20221 min read
23 views
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Swissmedic Guidance on Renewals, Variations & Extensions
On January 28, 2022 Swismedic released a list of guidances for different segments, check out the below important list of swiss medic...
Sharan Murugan
Feb 6, 20221 min read
231 views
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Swissmedic- Updated Guidance on Authorisation of Human Med.Product with New Active Substance
On 17.09.2021, swiss medic released an updated Guidance on Authorisation of Human Medicinal Product with New Active Substance HMV4. The...
Sharan Murugan
Sep 23, 20211 min read
90 views
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Swissmedic Updates Forms for New Authorization, Variations & Extensions-Switzerland
On 01.09.2021, Swissmedic updated the forms for New authorisation of human medicinal products HMV4 and Variations and authorisation...
Sharan Murugan
Sep 7, 20211 min read
30 views
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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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Guidance on Packaging for Human Medicinal Products, Med.Prod Names & eSubmissions platform - Swiss
Guidance document Packaging for Human Medicinal Products HMV4 This guidance document explains how primary and secondary packaging...
Sharan Murugan
Jul 19, 20211 min read
4 views
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