GDP Statement

Company VEZ Farmachem d.o.o. with a seat at Strojarska 20, 10000 Zagreb, Croatia,
operates in compliance with EU GMP Volume 4, Part II – (Basic Requirements for Active
Substances used as Starting Materials), Chapter 17, and Guidelines of 19 March 2015 on
principles of Good Distribution Practice of active substances for medicinal products for
human use.

In this respect, all operations are fully in compliance with GDP requirements and all
documentation is prepared and readily available.

NATIONAL DRUG AND MEDICINAL AGENCY (HALMED) APROVAL No. is: 381-10-
05/228-17-05 dated 24.10.2017.

VEZ Farmachem d.o.o. operates in accordance with implemented Quality Management System (QMS) that governs processes, procedures, and responsibilities for achieving our quality policies and objectives.
There are 23 Standard Operating procedures in place which are covering both Active Pharmaceutical Ingredients and Medical Devices.
All the QMS documentation is readily available for inspection during audit.