In accordance with our mission all activities are performed in compliance with ISO 9001 quality management standard. First time we got its certificate in 1998 from SGS Yarsley International Certification Services certification body.

We had the latest audit in 2021 June concerning ISO 9001 and ISO 14001 which was successful.

In addition the production of in vivo pharmaceuticals is performed in compliance with requirements of GMP (Good Manufacturing Practice) which is regulated in Hungary by 44/2005 (X.19.) order of Health Ministry, and its realisation is regularly inspected by Directorate General of National Institute of Pharmacy and Nutrition.

All our products, as well as their production, storage and delivery meet the strictest security requirements. Prevention of radioactive pollution of the environment is guaranteed by a multilevel safety system.

All in vitro diagnostic products have CE compliance mark required by 8/2003 (III.13.) order of Ministry of Health, Social and Family affairs. PSA kits risk assessment have certification required by this order.

Immunoassay Business Line has certified quality management system according to ISO13485 standard for design, production and distribution of radioactive immunoassay kits.

All certificates were issued by National Institute for Quality- and Organizational Development in Healthcare and Medicines / Directorate of Device Testing and Clinical Engineering.

Our Integrated Management System Policy read HERE

Pharmacovigilance  Drug Safety / Adverse Event Reporting:
Reporting suspected adverse reactions is important, not only set in the EU guidelines, but it enables us to monitor the benefit/risk balance of the product. In case of any suspected adverse reactions a brief report should be sent to the attention to our Pharmacovigilance Responsible Expert at:  gyogyszerbiztonsag@izotop.hu

Further information:

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