New on this website

01.02.2026

Updating of Annex 7 TPLRO – Revised list of variations

A revised list of variations according to Articles 21-24 TPO comes into force on 1 February 2026

01.02.2026

Changes to the Guidance document Drug Safety Signals HMP and the Signal Notification Form

The Guidance document Drug Safety Signals HMP has been comprehensively revised, its structure has been modified and its content has been clarified; in parallel, the Signal Notification Form has been revised and adapted to the new requirements

01.02.2026

Archiving of information sheets on specimen texts for medicinal product information for analgesics

The information sheets on specimen texts for medicinal product information for paracetamol, acetylsalicylic acid and NSAIDs are to be archived

30.01.2026

Swiss Pharmacopoeia

from recipe book to mandatory quality standard

30.01.2026

Market surveillance of medical devices

Results of a Swissmedic focus campaign of importers

30.01.2026

Summary report on authorisation – Alyftrek®

First authorisation

30.01.2026

Summary report on authorisation – Obgemsa®

First authorisation

30.01.2026

Version 2.1 of the «Schweizerische Gute Praxis für die Instandhaltung von Medizinprodukten» (GPI)

GPI version 2.0 have been updated to Version 2.1. This revision clearly reflects the requirements set out in Art. 71 para. 2 MedDO and Art. 64 para. 2 IvDO. Details can be found in the document's change history.

29.01.2026

Summary report on authorisation – Nubeqa®

Extension of therapeutic indication (02)

28.01.2026

DHPC – Ocrevus® (Ocrelizumab)

Leberschädigung mit Ocrelizumab

27.01.2026

Summary report on authorisation – Hepcludex®

Extension of therapeutic indication (01)

23.01.2026

DHPC – Arixtra® (fondaparinuxum natricum)

Ernsthafter Qualitätsmangel im Zusammenhang mit der Nadel der vorgefüllten Spritze

22.01.2026

Batch recall – Risperidon-Mepha LA Pulver und Lösungsmittel zur Herstellung einer Suspension zur i.m. Injektion

Rückzug der Chargen 4400869, 4400443, 4400446 und 4401766 bis auf Stufe Detailhandel

19.01.2026

Summary report on authorisation – Amvuttra®

Extension of therapeutic indication (01)

15.01.2026

Summary report on authorisation – Calquence®

Extension of therapeutic indication (01)

15.01.2026

Redundancy scheme for announced headcount reduction at Swissmedic approved

Agreement will permit socially acceptable implementation of staff reduction

13.01.2026

Reassessment of the safety of blood transfusions with regard to vCJD

New blood donation criteria from Swiss Transfusion SRC effective 1 February 2026

13.01.2026

Out-of-Stock – Abilify i.m. Injektionslösung 7.5mg/ml

Befristete Bewilligung zum Vertrieb in deutscher Aufmachung

12.01.2026

swissdamed Webinar: How to register and manage medical device data in swissdamed

On 28 May 2026, Swissmedic is hosting a free online training on how to register medical devices in swissdamed

12.01.2026

Change in Swissmedic top management: Executive Director Vincenza Trivigno takes up her post

On 12 January 2026, Vincenza Trivigno will take up her post as Executive Director of Swissmedic

08.01.2026

Batch recall – Locametz 25 mcg Mehrfachdosis-Kit für ein radioaktives Arzneimittel

Rückzug der Chargen PG21CH2507 und PG21CH2508 / Bulk Batch ID: F0392504 bis auf Stufe Detailhandel (Klinik / Spital)

08.01.2026

Out-of-Stock – Enrylaze 10 mg/Vial Injektionslösung

Befristete Bewilligung zum Vertrieb in irischer, schwedischer und finnischer Aufmachung

07.01.2026

Scientific GMDP Meetings for the clarification of GMP/GDP-related questions

A forum for the targeted clarification of project-specific GMP and GDP issues with Swissmedic

07.01.2026

Swissmedic Journal

Latest edition
Swissmedic Journal Dezember 2025

06.01.2026

Product Owner (80-100%)

Job advertisement | Division Operational Support Services

06.01.2026

Phosphonorm® administered instead of Phoscap capsules

Learning from adverse reaction reports – cases from pharmacovigilance

06.01.2026

Out-of-Stock – Xenpozyme Pulver zur Herstellung einer Lösung zur intravenösen Infusion

Befristete Bewilligung zum Vertrieb in taiwanesischer Aufmachung

06.01.2026

Updating of Annex 7 TPLRO – Revised list of variations

A revised list of variations according to Articles 21-24 TPO comes into force on 1 February 2026

01.01.2026

Fassung 12.1 der Europäischen Pharmakopöe in Kraft

Der Institutsrat hat die Fassung 12.1 der Europäischen Pharmakopöe auf den 1. Januar 2026 in Kraft gesetzt

01.01.2026

Changes to the Guidance documents Product information for veterinary medicinal products and Packaging texts for veterinary medicinal products

With effect from 1 January 2026, it will be possible to dispense with a paper copy of the package leaflet for certain veterinary medicinal products.

30.12.2025

Out-of-Stock – Sevelamercarbonate Salmon Pharma 800 mg Filmtabletten

Befristete Bewilligung zum Vertrieb in deutscher Aufmachung

29.12.2025

Summary report on authorisation – Pemazyre®

Extension of therapeutic indication (01)

23.12.2025

Batch recall – Esomeprazol MUT Sandoz magensaftresistente Tabletten

Rückzug der Chargen 239415, 239425, 239240, 239187, 239208, 239287, 239283 bis auf Stufe Detailhandel

23.12.2025

Batch recall – Ringerfundin B. Braun Infusionslösung

Rückzug der Charge 253527651 bis auf Stufe Detailhandel

23.12.2025

Summary report on authorisation – Jaypirca®

Extension of therapeutic indication (01)

23.12.2025

Summary report on authorisation – Sephience®

First authorisation

23.12.2025

Deadline for Device Registration in swissdamed

The registration of devices, systems, and procedure packs will become mandatory in swissdamed as of July 1, 2026, with a transition period until December 31, 2026

19.12.2025

Summary report on authorisation – Jeraygo®

First authorisation
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