Licensing and safety
This section of the Novartis RLT Institute reviews important aspects for obtaining or amending a radioactive materials (RAM) license for medical use, including types of licenses, components of the application, and key individuals, focusing on the key considerations for a radioligand therapy (RLT) program.
RAM licensing
License maintenance
Maintaining a current and accurate RAM license is the responsibility of the licensee. Any modifications or changes to the information provided in the original application require the submission of a license amendment request.1
Importantly, changes cannot be implemented until the amendment has been officially reviewed and issued by the regulatory authority. This process ensures continued compliance and safety in all licensed activities.1
Amendments
Amendments must be submitted for most changes to the RAM program.1 Examples of changes that may require the submission, review, and acceptance of an amendment include:
- Changing personnel such as radiation safety officers1
- Adding or changing personnel such as authorized users (typically required for limited scope licenses only)1,2
- Changing the amount of RAM from the originally authorized quantity1
- Receiving radionuclides different from those specified in the license1
- Changing the address of the facility1
- Changing the manufacturer (if defined in the license)1,3
- Changing or updating certain procedures1
Renewals
Licensees are also responsible for filing renewal documentation which consists of all the information required for initial licensure. The timeline for submitting a renewal application in proper form is not less than 30 days prior to the license expiration date.4 A licensee may be cited for a violation if the licensee is in possession of RAM with an expired license.
Audits and inspections
State regulatory bodies and the Nuclear Regulatory Commission may perform inspections and audits, sometimes with advanced notice and sometimes unannounced.5