This webinar is an introduction to Organisation Management Service (OMS) and Referentials Management Service (RMS) services and activities for industry users.

This event aims to inform SMEs and academic sponsors of clinical trials on how to prepare for the main changes brought by the Regulation and its impact on their trial-related activities.

quality of medicinal products and, with this knowledge, actively supports applicants in the approval of their medicinal products. BASG actively invests in the know-how of its employees. Regular training [...] consistently high level. Additionally, Austria actively participates in shaping relevant committees. Austria is strongly participating in decisions and activities of the Coordination group for Mutual recognition [...] to the assessment of Certificates of Suitability (CEPs) and a key member in the development of the Active Substance Masterfile (ASMF) repository. Furthermore, the well-established Case Managers ensure prompt

Recall due to azido contamination above the acceptable limit.

Recall due to azido contamination above the acceptable limit.

Recall following a Commission Decision concerning veterinary medicinal products for injection containing vitamin A as active substance

Recall of one batch due to presence of ciclosporine cristals.

Recall due to azido contamination above the acceptable limit.

Recall due to azido contamination above the acceptable limit.

Up-to-date information from the 19.07.-22.07.2021 meeting on new approvals, extensions of indication, newly published EPARs and recently started procedures.