Austria

Pharmaceutical Companies that distribute medicines in Austria require a Wholesale Dealer License (WDL) granted by Austrian Federal Office for Safety in Healthcare after successful inspection. The primary goal of the inspection is to determine whether the various elements within the quality assurance system are effective and compliant with Good Manufacturing, Distribution and Vigilance Practice GMP/GDP/GVP principles and whether the management of the company has the sufficient qualifications. The minimum employees required to start a pharmaceutical company in Austria are a Commercial General Manager, a Managing Director and a Responsible Person.

ARAC GMBH is our team located in Vienna, Austria. They can help you with preparations and assist you during inspections. Their services include:

• Creation of the Site Master File
• Writing of SOPs
• Completing the required official forms
• Creation of organization charts incl. job description