Operating License for Radiopharmaceutical Production Facility
UMKU PB Details
Parameter: All
Authority: Minister/Head of Agency
-
Requirements
- 1. Report on the implementation of commissioning; Duration: -
- 2. As-built drawings; Duration: -
- 3. Certificate of quality compliance for Ionizing Radiation Source; Duration: -
- 4. Competence and authorization data for personnel;
- Radiation protection personnel;
- Personnel responsible for the security of radioactive materials;
- Other personnel
- 5. Documentation for radiation protection and safety, and/or safety of radioactive materials programs; Duration: -
- 6. Proof of ownership and/or control of Ionizing Radiation Source; Duration: -
- 7. Safety assessment documents for Ionizing Radiation Source and/or safety assessment for radioactive materials; Duration: -
- 8. Management system documentation; Duration: -
- 9. Maintenance program documentation; and Duration: -
- 10. Decommissioning program documentation for Ionizing Radiation Source facilities; Duration: -
-
Obligations
- 1. Produce products in accordance with the license issued by the Regulatory Body; Duration: -
- 2. Implement the provisions contained in the management system; Duration: -
- 3. Ensure that radiation protection and safety, and safety of radioactive materials requirements are met; Duration: -
- 4. Provide an opportunity for the Head of the Regulatory Body to conduct inspections during the validity of the license; Duration: -
- 5. Take necessary measures to prevent unauthorized transfer, theft, and sabotage of radioactive materials; Duration: -
- 6. Ensure that activities are conducted in accordance with the issued license; and Duration: -
- 7. Submit safety and security verification reports for radioactive materials to the Regulatory Body periodically each year, starting from the Business Permit issuance. Duration: -
Sector: Nuclear Energy Regulatory Agency
Status: Available
Belongs to:
Need advice on setting up a company in Indonesia?
KBLI.co.id is a subsidiary of Emerhub, the largest independet corporate advisory firm in Indonesia.
![](/img/assistance.png)
Schedule a free consultation
Share your plans for Indonesia with us, and our advisors will recommend the most appropriate type and classification of legal entity for your needs.
![](/img/options.png)
No commitment required
We recognize that you might be in the exploratory phase of deciding whether and how to expand into Indonesia. Allow us to simplify this process for you.
![](/img/qualified.png)
Always credible information
Due to frequent changes in regulations and government policies, there is a prevalence of misleading and outdated advice. As we handle company registrations daily, we are well-informed about the most current information.