Archive

22.12.2016

Swissmedic’s approach to handling EC certificates for medical devices

Swissmedic has decided to follow the harmonised European procedure.

20.12.2016

ICH Assembly in Osaka, Japan, 5 to 10 November 2016

The International Council for Harmonisation (ICH) met in Osaka, Japan from 5 to 10 November 2016.

19.12.2016

Swissmedic patient / consumer organisations working group

Pilot to be extended by another two years

14.12.2016

Adaptation of formal requirements for marking/highlighting changes in manuscripts of medicinal product information (information for healthcare professionals and patient information)

The new requirements for manuscript presentation apply to all new submissions made to Swissmedic as of 1 January 2017.

05.12.2016

New eGov Service “eSubmissions” (pilot operation)

New eSubmissions platform

01.12.2016

35 new psychoactive substances added to Narcotics List

The Federal Department of Home Affairs (FDHA) has prompted to add 35 substances to the Narcotics List.

25.11.2016

Vigilance-News Edition 17

New edition

20.10.2016

Manufacturer information data quality

The current (divided) Manufacturer Information form can still be submitted during a transitional period until the end of November 2016.

11.10.2016

International Summit of Heads of Medicines Regulatory Agencies opened in Interlaken: Swissmedic agrees on closer collaboration with UK partner agency

Federal Councillor Alain Berset opened the International Summit of Heads of Medicines Regulatory Agencies today in Interlaken.

21.09.2016

Haemovigilance Report 2015

Current figures and findings important for transfusion safety in Switzerland

13.09.2016

Important safety information regarding GlucaGen® Hypo-Kit

Recall of two batches (FS6X327, FS6X986) of GlucaGen® HypoKit glucagon for injection

01.09.2016

Changes regarding transfer of marketing authorisation and change to name or address of marketing authorisation holder

Requests submitted as of 1 September 2016 will have to comply with the new instructions.

05.08.2016

New Head of Communication and media spokesperson at Swissmedic

Danièle Bersier has become Swissmedic’s new Head of Communication and media spokesperson.

25.07.2016

Extension of time limit for submitting Drug Master Files and Active Substance Master Files before submitting application

The guidance document Formal requirements and the form DMF for first authorisation/variation will be adapted.

25.07.2016

Adaptation of the form Manufacturer information and new form Responsible Person Declaration

The new form Manufacturer information (version 7.0) will be available on the Swissmedic website in July 2016.

20.07.2016

Ausbau Swissmedic eGovernment Portal

Registrierte und berechtigte Nutzer von Firmen mit Betriebsbewilligung können künftig einen grossen Teil der Korrespondenz direkt und ohne Papierverkehr elektronisch abwickeln.

04.07.2016

ICH Meeting in Lisbon, Portugal, 11 to 16 June 2016

The International Council for Harmonisation (ICH) met in Lisbon, Portugal from 11 to 16 June 2016.

28.06.2016

Action plan to combat illegal fresh cell therapies

The outcome at the end of the campaign

03.06.2016

The new Swissmedic Annual Report has been published

An entire year's work by 424 individuals summed up in 90 pages: that's the new Swissmedic Annual Report.

25.04.2016

Hinweis betreffend angepasster Beschriftung der Verpackung von Distraneurin Kapseln, Zulassungsnummer: 40629

Distraneurin Kapseln enthalten seit der Erstzulassung 192 mg Clomethiazol, freie Base. Diese Arzneiform (Kapseln) enthält kein Clomethiazol-Edisilat. Der bisher auf der Faltschachtel und Etikette angebrachte Hinweis auf die Salzform (ut Clomethiazoli edisilas 300 mg) war damit nicht konform und wurde im Rahmen einer Änderungsanzeige gestrichen.

01.04.2016

Änderung im Pflichthinweis für Arzneimittelwerbung ab 1. April 2016 - Inkrafttreten der Teilrevision der Arzneimittel-Werbeverordnung (AWV)

Am 1. April 2016 tritt eine Teilrevision der Arzneimittel-Werbeverordnung in Kraft, mit der insbesondere die folgenden Artikel der AWV geändert oder neu aufgenommen werden: Art. 16 Abs. 5 Bst. c, Art. 17 und Art. 17a (neu).

04.03.2016

Hepatitis medicines: Warning concerning Harvoni® packs with counterfeit contents

Counterfeit packs of the preparation Harvoni® have been discovered in Israel. The Swiss Agency for Therapeutic Products Swissmedic is working with other European authorities to establish whether Harvoni® packs with counterfeit contents have also been imported into other countries.

01.03.2016

New requirement for new applications for authorisation as a result of the Nagoya Ordinance

As a result of the new requirements, a passage dealing with the Nagoya Ordinance has been added to the Swissmedic forms for application submission.

01.03.2016

Change in practice in the classification of herbal substances or preparations for oral administration to animals and in products for bees

Herbal products that are administered orally to animals as feeds or as veterinary medicinal products are classified jointly by Agroscope and Swissmedic.

01.03.2016

Additional information on submitting Drug Master Files and Active Substance Master Files

The guidance document Formal requirements and the form DMF for first authorisation/variation have been updated. The changes take immediate effect.

11.02.2016

Zika Virus Press Release of the International Coalition of Medicines Regulatory Authorities, ICMRA

Global medicines regulators pledge support to tackle Zika virus disease

01.01.2016

Procedure with prior notification: Changes as of 1 January 2016

When the Ordinance on Fees for Therapeutic Products (HGebV, SR 812.214.5) came into force on 1 January 2013, it introduced a procedure with prior notification (PPN).

15.12.2015

Der Kampf gegen Designerdrogen geht weiter

Um den Kampf gegen neue Designerdrogen erfolgreich führen zu können, verbietet die Schweiz weitere 21 Einzelsubstanzen.

09.12.2015

Akzidentelle Überdosierungen von Low Dose Methotrexat

Gemeinsame Mitteilung der Swissmedic und der Stiftung für Patientensicherheit (SPS)

07.12.2015

Information zu Laboratoire Stallergenes

Auslieferungsstopp für allergologische Arzneimittel der Firma Laboratoire STALLERGENES Greer SAS, F-Antony Cedex, Frankreich

04.11.2015

Sicherheitshinweis zu ala®octa

Swissmedic informiert, dass die Firma alamedics ab sofort die Verwendung ihres Produkts ala octa untersagt.

31.10.2015

Change in practice for variations requiring notification

No official decision letter if notification is approved.

https://www.swissmedic.ch/content/swissmedic/en/home/news/mitteilungen/archive.html