Pharmaceutical Wholesale License

Operating a pharmaceutical wholesale business in Germany requires a license under Section 52a of the Medicines Act (AMG). This covers any business that procures, stores, and distributes medicines to pharmacies, hospitals, or other authorised recipients. Over-the-counter medicines not restricted to pharmacies are exempt.

You apply at the state health authority where your business premises are located. The authority must decide within three months. Requirements include suitable premises with proper storage conditions (temperature control, security, separation of product categories), a qualified responsible person (verantwortliche Person) with pharmaceutical expertise, and a written commitment to comply with Good Distribution Practice (GDP). The authority inspects the premises before issuing the license and conducts periodic follow-up inspections.