FAQ Authorisation (Kopie 1) (Kopie 1) How long does it take to get an authorisation? I would like to withdraw my application for an operating license according to § 63 AMG or an extension of the opera

Recall due to reduced release of active pharmaceutical ingredient

Recall due to visible particles

Informationen zur Inspektionsvorbereitung

Referenced at:

• FAQ - GLP
• FAQ - GLP

National authorisation and lifecycle forms New National authorisation and registration Electronic Application Forms have to be used for: New Applications according to §§ 7a, 9a, 9b, 9c, 9d, 10 Abs. 1(

ÄNDERUNGEN GEMÄSS § 24 AMG idgF Institut Zulassung & Lifecycle Management Traisengasse 5, 1200 Wien ÄNDERUNGEN GEMÄSS § 24 AMG idgF 1. Angaben zum Antrag ☒ human ☐ Antrag auf genehmigungspflichtige Än

Referenced at:

• National authorisation and lifecycle forms
• National authorisation Life-Cycle forms

Recall due to not registered serial numbers

Further information and amendments to the product information in all EU languages are available on the EMA website.

• link
  Link to the EMA Website

Further information and amendments to the product information in all EU languages are available on the EMA website.

• link
  Link to the EMA Website

Further information and amendments to the product information in all EU languages are available on the EMA website.

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• link
  Link to the EMA Website