Recall due to possible reduced active ingredient content

Recall due to insufficient active substance release

Up-to-date information from the 19.06.-22.06.2023 meeting on new approvals, extensions of indication, newly published EPARs and recently started procedures.

Recall due to increased release of active ingredient

New recommendations for the composition of seasonal influenza vaccines for the season 2023/2024 adopted.

Up-to-date information from the 24.04.-26.04.2023 meeting on new approvals, extensions of indication, newly published EPARs and recently started procedures.

Up-to-date information from the 27.03.-30.03.2023 meeting on new approvals, extensions of indication, newly published EPARs and recently started procedures.

Up-to-date information from the 20.02.-23.02.2023 meeting on new approvals, extensions of indication, newly published EPARs and recently started procedures.

Technical advice on CESP submission: 1.2.1.1 Entries in the delivery file: in the field “Regulatory Activity:” Clinical trial in the field “Comment:” at submission of the application: Application_YYYYMMDD

Referenced at:

• Clinical trials

tissue type, it is imperative to notify the BASG before starting the new activity. The EGE is entitled to carry out the new activity only after the inspection has been carried out and the procedure has been [...] Act Is the responsible person also liable for the activities of the procurement center ? No. The "responsible person" is not liable for the activities of the procurement center. According to § 9 Austrian [...] made at home (partner donation)? 10. What requirements are placed on premises in which processing activities with regard to air quality? 11. What are the costs of an authorisation or inspection procedure