Messages in brief

News

COVID-19: Regulatory flexibility

messages in brief | 22/04/2020
Recent information about regulatory flexibility during the corona pandemic can be found here on the website of the BASG.
COVID-19: Regulatory flexibility Read more
News

EU Recommendations for the Seasonal Influenza Vaccine Composition for the Season 2020/2021

messages in brief | 22/04/2020
The EMA adopted the new recommendations for the composition of seasonal influenza vaccines for the season 2020/2021 (published 1 April 2020).
EU Recommendations for the Seasonal Influenza Vaccine Composition for the Season 2020/2021 Read more
News

New practice for sodium in the product information

messages in brief | 17/04/2020
In the EMA document "Compilation of QRD decisions on stylistic matters in product information" a new, Europe-wide harmonised practice for oral/parenteral medicinal products containing less than 1 mmol sodium per dose was published. In section 2 of the SmPC, there is no need to declare sodium, neither qualitatively nor quantitatively for oral/parenteral medicinal products containing less than 1 mmol sodium per dose. Section 3 of the labelling there is no need to declare sodium for oral medicinal products containing less than 1 mmol of sodium per dose.
New practice for sodium in the product information Read more
News

COVID-19: Warnung vor falscher Anwendung von Chloroquin

messages in brief | 02/04/2020
Chloroquin und Hydroxychloroquin dürfen gegen Corona-Virus nur in klinischen Studien oder Notfallprogrammen verwendet werden
COVID-19: Warnung vor falscher Anwendung von Chloroquin Read more
News

The regulation on ensuring the supply of medicinal products enters into force as from April 1, 2020

messages in brief | 29/03/2020
The regulation on ensuring the supply of medicinal products enters into force as from April 1, 2020, and comprises any restriction in supply of prescription-only human medicines.
The regulation on ensuring the supply of medicinal products enters into force as from April 1, 2020 Read more
News

Anwendung von Arzneimitteln gegen Bluthochdruck, Herz- oder Nierenerkrankungen während COVID-19-Pandemie beibehalten

messages in brief | 27/03/2020
Keine Hinweise die Zusammenhang zwischen ACE-Hemmern oder ARBs und Verschlechterung von Coronaerkrankung belegen, daher Therapie nicht abbrechen/umstellen
Anwendung von Arzneimitteln gegen Bluthochdruck, Herz- oder Nierenerkrankungen während COVID-19-Pandemie beibehalten Read more
News

Riskevaluation Nitrosamins: Extention of Deadline to complete Step 1 to 1 October 2020

messages in brief | 26/03/2020
Based on the current situation it has been agreed between the EMA and NCAs to extent the deadline for submission to complete Step 1 for the evaluation of the risk of the presence of nitrosamine impurities in human medicinal products containing chemically synthesised active pharmaceutical ingredients, from 26. March 2020 to 1. October 2020.
Riskevaluation Nitrosamins: Extention of Deadline to complete Step 1 to 1 October 2020 Read more
News

COVID-19: Vorsicht vor gefälschten Arzneimitteln von illegalen Online-Apotheken

messages in brief | 24/03/2020
Das BASG erinnert die Bevölkerung daran, keine Arzneimittel von nicht autorisierten Websites und/oder illegalen Anbietern zu kaufen.
COVID-19: Vorsicht vor gefälschten Arzneimitteln von illegalen Online-Apotheken Read more
News

Verwendung von Ibuprofen und anderer nichtsteroidaler Entzündungshemmer bei COVID-19

messages in brief | 18/03/2020
Keine wissenschaftlichen Beweise für Zusammenhang zwischen Ibuprofen und Verschlechterung von COVID 19
Verwendung von Ibuprofen und anderer nichtsteroidaler Entzündungshemmer bei COVID-19 Read more
News

Update: COVID-19 - Changes for clinical trials

messages in brief | 17/03/2020
The Federal Office for Safety in Health Care publishes an FAQ on the sending of study medication in the context of the COVID-19 pandemic.
Update: COVID-19 - Changes for clinical trials Read more
keyboard_arrow_up to top