Certification and authorization

Providing safe, high-quality products and constantly attending to the needs and wishes of our customers are the primary objectives for Prisum Healthcare. 

The passion with which we pursue our goals, the inspiration we show in the choices we make and the courage that characterizes us in assuming the responsibilities of each of us, are the necessary elements for a healthy growth that respects high standards of quality and integrity, with a positive impact on employees, society and the environment. 

Prisum Healthcare has the following certifications and authorizations:

NAMMD - Certificate of Good Manufacturing Practice no. 013 / 2023 / RO issued by The Romanian National Agency for Medicines and Medical Devices (PDF, Romanian language)

NAMMD - Certificate of Good Distribution Practice no. 043 / 2023 / RO issued by The Romanian National Agency for Medicines and Medical Devices (PDF, Romanian language)

NAMMD - Notice of operation of medical devices no. 5194 of 16.06.2023 issued by The Romanian National Agency for Medicines and Medical Devices (PDF, Romanian language)

NAMMD - Manufacturing authorization no. 76I of 27.06.2023 issued by The Romanian National Agency for Medicines and Medical Devices (PDF, Romanian language)

NAMMD - Distribution authorization no. 63D of 23.05.2023 issued by The Romanian National Agency for Medicines and Medical Devices (PDF, Romanian language)

ISO 9001:2015 - Certificate no. 21746 C for Quality Management System that complies with the requirements of the ISO 9001:2015 standard (PDF, Romanian language)

ISO 22000:2019 - Certificate no. 21746 H for Quality Management System that complies with the requirements of the ISO 22000:2019 standard (PDF, Romanian language)