Low volumes of the nasal sprays has been observed, possibly due to evaporation from the bottles.

The EC has published a useful summary of applicable EU rules after the end of the transition period. You can find the link here on the website of the BASG.

Also in the future, we want to continue to inform our applicants of marketing authorisation procedures with Austria as RMS with relevant news from the committees or exciting innovations such as the slot application via our eServices!

The fees valid on the date of application at BASG after 01.07.2020.

Referenced at:

• Fees

Dissolution of an active substance may be slowed down.

Central contact points in each federal state survey needs and coordinate distribution

example, the extent of actual pharmacovigilance activities in Austria (number of cases/PSUR statistics), requirements from RMPs, service provider activities, etc. Another selection criterion for an inspection [...] Pharmacovigilance Practice (GVP) modules that regulate the implementation of pharmacovigilance activities. The first GVP modules came into force in July 2012, and further modules were published in the

facilities Radioactive irradiation In Article 5(1) of Directive 2002/98/EC it is laid down that activities relating to the collection and testing of human blood and blood components, whatever their intended

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.

on) * • market surveillance and vigilance * • other procedures and anwering queries * fields of activity: • medicinal products *) • medical devices ) • blood ) • tissues ) • narcotics ) framework of the

Referenced at:

• Tasks and Activities