Up-to-date information from the 22.01.-25.01.2024 meeting on new approvals, extensions of indication, newly published EPAR's and recently started procedures.

undertakes a number of activities, including drafting legislation and developing guidelines, supporting national authorities with its implementation, accompanied by vigilance activities and project support

carried out for all products and serves to estimate the environmental impact of a given product, its active substance(s) and excipients. Based on what is referred to as the decision tree (a set of 19 questions [...] mutual recognition, and decentralised procedures: New applications (full applications for new or known active substances) Generic, bibliographic, hybrid, and informed consent applications Extensions (considered [...] increase in environmental risk (i.e., when there is an increase in environmental exposure or when the active substance enters a previously unaffected compartment). Thus, the following extensions may require

accordance with para 2, the patient leaflet of proprietary medicinal products containing illicit active substances in accordance with Art 1 para 2 of the Federal Anti-Doping Act (Anti-Doping-Bundesgesetz) [...] irrelevant whether the substance contained in the proprietary medicinal product is qualified as an active ingredient or an excipient. Prohibited List (Verbotsliste) substance list_2024 | 135 KB 01/03/2024

Recall due to inadequate water content

Up-to-date information from the 11.12.-14.12.2023 meeting on new approvals, extensions of indication, newly published EPAR's and recently started procedures.

Recall due to reduced release of active pharmaceutical ingredient

The fees valid on the date of application at BASG after 01.01.2024.

Referenced at:

• Fees

c Advice) V.3.a bei im EWR neuen Wirkstoffen (new active substances), sowie Biosimilars 11.419 V.3.b bei im EWR bekannten Wirkstoffen (existing active substances) 7.137 V.4 Labortechnische Analysen für

Referenced at:

• Official announcements

buys the active substance/raw material required for the manufacture of tablets, for example, from another manufacturer. Due to globalisation and the trend towards mass production, such active ingredient [...] are committed to improving the availability of medicinal products in Europe. Activities of the BASG at European level Active participation in the Medicine Shortages Single Point of Contact (SPOC) Working [...] connection to the "European Shortages Monitoring Platform (ESMP)" Active participation in the "Solidarity Mechanism Working Group" Active participation in the thematic working group "Medicine availability