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News

Implementation of new QRD templates (veterinary) New

messages in brief | 24/05/2022
For the new QRD templates Vers. 9 veterinary, which take into account the requirements of the Veterinary Medicinal Products Regulation (EU) 2019/6, updated accessible Word templates are available for download.
Implementation of new QRD templates (veterinary) Read more
News

SPC harmonisation of veterinary medicinal products

messages in brief | 09/05/2022
With the entry into force of the Regulation (EU) 2019/6 a new procedure, the SPC harmonisation procedure, was created as per Section 4 of this Regulation.
SPC harmonisation of veterinary medicinal products Read more
News

EU Recommendations for the Seasonal Influenza Vaccine Composition for the Season 2022/2023

messages in brief | 02/05/2022
The EMA adopted the new recommendations for the composition of seasonal influenza vaccines for the season 2022/2023 (published 29 March 2022).
EU Recommendations for the Seasonal Influenza Vaccine Composition for the Season 2022/2023 Read more
News

Clinical studies and the war in Ukraine New

messages in brief | 05/04/2022
Clinical studies and the war in Ukraine - Information for Consumers.
Clinical studies and the war in Ukraine Read more
News

Clinical studies and the war in Ukraine New

messages in brief | 05/04/2022
Clinical studies and the war in Ukraine - Information for Healthcare Professionals.
Clinical studies and the war in Ukraine Read more
News

Current issue of “RMS NEWS”

messages in brief | 31/03/2022
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

Online-Form: Side effects veterinary drugs

messages in brief | 18/02/2022
Reporting suspected adverse reactions to veterinary drugs is possible using an online form.
Online-Form: Side effects veterinary drugs Read more
News

Amendments to the AMG (Austrian Medicines Act, Arzneimittelgesetz) concerning notifications of discontinuation of placing on the market

messages in brief | 14/02/2022
With the AMG amendment of 14.02.2022, § 21(2) was changed to the effect that the BASG must now be notified four months (instead of the previous two months) in advance of a temporary or permanent discontinuation of the marketing of medicinal products.
Amendments to the AMG (Austrian Medicines Act, Arzneimittelgesetz) concerning notifications of discontinuation of placing on the market Read more
News

BASG information concerning the new Veterinary Medicinal Products Regulation

messages in brief | 07/02/2022
The new Veterinary Medicinal Products Regulation is to be applied as of 28.01.2022.
BASG information concerning the new Veterinary Medicinal Products Regulation Read more
News

Current issue of “RMS NEWS”

messages in brief | 31/01/2022
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
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