Messages in brief
Visit of the new Director of the Medicines Agency of Liechtenstein
messages in brief
|
03/02/2023
Dr. Vlasta Zavadova, Director of the Liechtenstein Medicines Agency visits AGES Medical Market Surveillance for further development of the State Treaty.
Visit of the new Director of the Medicines Agency of Liechtenstein
Read more
Visit of the President of the German Medicines Agency BfArM to the Austrian colleagues
messages in brief
|
25/01/2023
Prof. Dr. Karl Broich, President of the BfArM (Federal Institute for Drugs and Medical Devices) visits the AGES Medical Market Surveillance.
Visit of the President of the German Medicines Agency BfArM to the Austrian colleagues
Read more
Registration of an "Industry Single Point of Contact (i-SPOC)" for supply and availability at EMA
messages in brief
|
17/11/2022
i-SPOC registration has been mandatory since September 2, 2022 and applies to all pharmaceutical companies with a centrally- or nationally-authorised human medicinal product in the EU.
Registration of an "Industry Single Point of Contact (i-SPOC)" for supply and availability at EMA
Read more
#MedSafetyWeek from 7 to 13 November 2022
messages in brief
|
07/11/2022
Drug authorities around the world are reminding people of the importance of reporting suspected adverse drug reactions in a joint campaign called MedSafetyWeek.
#MedSafetyWeek from 7 to 13 November 2022
Read more
Current issue of “RMS NEWS”
messages in brief
|
30/09/2022
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
Current issue of “RMS NEWS”
messages in brief
|
30/06/2022
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
Implementation of new QRD templates (veterinary)
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
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
Clinical testing of veterinary medicinal products
messages in brief
|
09/05/2022
The new EU Veterinary Medicinal Products Regulation, which entered into force on 27/01/2019, is applicable from 28/01/2022. According to Article 9 of this Regulation, applications for approval of clinical trials of veterinary medicinal products shall be submitted to the competent authority of the Member State in which the clinical trial is to be conducted.
Clinical testing of veterinary medicinal products
Read more
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