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.
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.
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.
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.