Messages in brief

News

Current issue of “RMS NEWS”

messages in brief | 29/01/2021
This issue of RMS NEWS again contains current and relevant news for our applicants for marketing authorisations with Austria as RMS.
Current issue of “RMS NEWS” Read more
News

BREXIT – End of transition period

messages in brief | 22/01/2021
The United Kingdom has left the European Union and the transition period ended on 31 December 2020. This article gives a short overview about the current applicable rules.
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News

Authorisation of a second vaccine against COVID-19 (Moderna)

messages in brief | 12/01/2021
On 06. January 2021, "COVID-19 Vaccine Moderna" was authorised in the European Union as the second vaccine against SARS-CoV2.
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First marketing authorisation of a COVID-19 Vaccine (BioNTech)

messages in brief | 22/12/2020
Based on the recommendation by the European Medicines Agency (EMA), the European Commission issued the marketing authorisation for the COVID-19 vaccine Comirnaty (BioNTech).
First marketing authorisation of a COVID-19 Vaccine (BioNTech) Read more
News

COVID-19 vaccines: reporting of side effects or lack of effect

messages in brief | 18/12/2020
In Austria, adverse reactions can be voluntarily reported directly to the Federal Office for Safety in Health Care (BASG) by patients as well as their relatives.
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News

Accessible Patient Information leaflet

messages in brief | 17/12/2020
Due to current events, FAQ No. 2 on accessible information for use has been revised, to better reflect the current approach.
Accessible Patient Information leaflet Read more
News

Project Monitoring of advertising material for medicinal products in 2020

messages in brief | 09/12/2020
In order to monitor the advertising regulations according to the regulations of the Austrian Medicines Act, advertising is always checked to ensure that it complies with the legal requirements.
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News

Current issue of "RMS NEWS"

messages in brief | 29/09/2020
This issue of RMS NEWS again contains current and relevant news for our applicants for marketing authorisations with Austria as RMS.
Current issue of "RMS NEWS" Read more
News

BREXIT – current challenges for Marketing Authorisation Holders

messages in brief | 29/09/2020
In the following cases Marketing Authorisation Holders/Holders of a Registration need to act, these tasks have to be finalised until 31.12.2020.
BREXIT – current challenges for Marketing Authorisation Holders Read more
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