FAQ Import of medicinal products New 1. New Web Portal for the Submission of Applications or Notifications in Accordance with the Austrian Medicinal Products Import Act 2. Who is in charge of procedur

Marketing authorisation & life-cycle Registration in IRIS New Please note: From January 2025, registration in IRIS will be mandatory for all lifecycle procedures managed by the EMA. It is important to

RMS NEWS Here you will find interesting news and links to current RMS-relevant topics. NEWSTICKER 30.09.2024 New RECENT COMMITTEE NEWS New labelling requirements for metered dose inhalers (MDIs) conta

Vaccines New List of authorised vaccines List of vaccines no longer authorised Official Vaccination Recommendations in Austria COVID-19 vaccines Approval of vaccines Approval process for a vaccine Bat

Quality Management New The quality system of the Austrian federal Office for Safety in Health Care is operated by the Austrian Medicines and Medical Devices Agency and implements the requirements of I

GMP/ GDP Processing status Electronic submission Organisation Management Service (OMS) - Integration in EudraGMDP Information on inspection preparation Good Manufacturing Practice (GMP) refers to the

Pharmaceutical companies Register of authorised pharmaceutical companies in Austria This register provides an overview of the companies authorised in Austria pursuant to § 63 / § 63a of the Austrian M

Register of retailers Register of pharmaceutical retailers The register provides an overview of the notifications received by the BASG from pharmaceutical intermediaries pursuant to Section 71a of the

Clinical investigations with medical devices Regulation on electronic submission Electronic Submission Form of the BASG General requirements for applications (technical validation) Clinical investigat