President of the National Atomic Energy Agency

Licence to manufacture and process radioactive sources; deliberately add radioactive substances in the process of production of medicinal products

licence number: D-19925
issued on: 2016.08.19
expires on: indefinitely

President of the National Atomic Energy Agency

Licence to open a class I isotope laboratory; utilisation in the lab the sources and devices containing radioactive sources; storage the radioactive sources and nuclear materials; process and storage of radioactive waste; deliberately administer radioactive substances to animals for research purposes

licence number: D-19901
issued on: 2016.08.19
expires on: indefinitely

President of the National Atomic Energy Agency

Licence to install and operate equipment filled with radioactive sources; trade such equipment; trade in nuclear materials consisting in containers with depleted uranium shielding; import and export from the Republic of Poland medicinal products which have been enriched during manufacturing in radioactive substances and trade in such products; transport of radioactive sources and waste

licence number: D-19899
issued on: 2016.08.04
expires: indefinitely

Chief Pharmaceutical Inspector

Certificate of entry into the national register of manufacturers, importers and distributors of active substances

entry number: 117/WTC0348/API/15
issued on: 2021.04.08

Chief Pharmaceutical Inspector

Manufacturing/Importation Authorisation

authorisation number: 195/0348/15
issued on: 2021.07.23

Chief Pharmaceutical Inspector

Wholesale Distribution Authorisation

authorisation number: NZOH.5100.2.2020.MG.4
issued on: 2020.02.17

Chief Pharmaceutical Inspector

Certificate of GMP Compliance of Manufacturer for active substances

in connection with: 117/WTC0348/API/15
issued on: 2021.11.08

Chief Pharmaceutical Inspector

Certificate of GMP Compliance of Manufacturer for manufacturing and import

in connection with: 195/0348/15
issued on: 2022.03.17

Chief Pharmaceutical Inspector

Certificate of GDP Compliance of a Wholesale Distributor

in connection with: NZOH.5100.2.2020.MG.4
issued on: 2022.10.21

Polish Centre for Testing and Certification

design, production, quality control and sales of radioactive products and radiopharmaceuticals, servicing of isotopic apparatus, transport and forwarding of radioactive goods

in conformance with: PN-EN ISO 9001:2015-10
number: J-2358/4/2021
issued on: 2021.03.20
expires on: 2024.03.19

Polish Centre for Accreditation

Accreditation Certificate of Calibration Laboratory – AP 120

for meeting requirements of the: PN EN ISO/IEC 17025:2018:02
granted on: 2008.12.19
issued on: 2020.01.31
accreditation cycle: 2020.12.15 – 2024.12.18

HQC Group

Halal Quality Control Certificate

reference standards: OIC/SMIIC 1:2019 / SNI 99004:2021
certificates numbers: FR10210201395 / FR10210201396
issued on: 2023.09.11
expires on: 2024.09.10

President of the Civil Aviation Office

Known Consignor

granted: 2022.01.31