BAPETEN Coordination Meeting for Radioisotope and Radiopharmaceutical Production Permits
Kembali 05 Maret 2024 | Berita BAPETEN

On March 5, 2024, BAPETEN's Directorate of Licensing of Radiation Facilities and Radioactive Materials (DPFRZR) held a coordination meeting in Jakarta to improve the ease and speed of business licensing services for radioisotope and radiopharmaceutical production licenses.

The event was opened by the Director of DPFRZR BAPETEN, Ishak, who stated in his opening remarks, "This coordination meeting aims to discuss problems and challenges related to radioisotope and radiopharmaceutical production permits so that the licensing process can be accountable according to legislation and transparency."

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The event continued with several presentations, namely a presentation on "Mechanisms for the Licensing Process for Production of Radioisotopes and Radiopharmaceuticals" by the Coordinator of the BAPETEN Health Facilities Licensing Function Group Iin Indartati, a presentation on "Acceptance Criteria: Radiation Protection and Safety Program Documents, Radioactive Substance Safety Program Documents and Treatment Program Documents ” by BAPETEN Radiation Supervisor Herry Irawan, presentation on “Acceptance Criteria: Safety Study Document for Ionizing Radiation Sources, Safety Study Document for Radioactive Substances, and Radioisotope Production Management System Document” by BAPETEN Radiation Supervisor Made Pramayuni.

And a presentation on "Acceptance Criteria: Decommissioning Program Documents, Proof of Ownership and/or Mastery of SRP, and Data on Competency and Authority of Officers" by BAPETEN Radiation Supervisor Ahmad Maulana; a presentation on "Requirements for Permits for the Transfer of Radioactive Substances and Approval of Delivery of Radioactive Substances" by the Radiation Supervisor BAPETEN Vatimah Zahrawati; and a presentation on "Radioisotope Production for Radiopharmaceuticals" by BAPETEN Health, Industry, and Research Regulatory Function Group Coordinator Soegeng Rahadhy.

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The coordination meeting was attended by all hospitals with cyclone facilities for producing radioisotopes and radiopharmaceuticals, license applicants in the industrial sector producing radioisotopes and radiopharmaceuticals, and BAPETEN-related work units.

During the discussion and question-and-answer session, participants asked a variety of questions about licensing applications through Online Single Submission Risk Based Approach(OSS-RBA) using The Indonesian Standard Business Field Classification (KBLI), the requirements for Good Manufacturing Practice for Drugs (CPOB) and distribution permits issued by The Indonesian Food and Drug Authority (BPOM) for hospitals, licensing document requirements, and the transfer or distribution process for radioisotopes and radiopharmaceuticals produced in hospitals.

The coordination meeting was closed by BAPETEN's Director of Licensing for Radiation Facilities and Radioactive Substances, Ishak, who stated in his closing speech that "this meeting hopes that the challenges in the licensing process can be resolved so that the licensing process can be accelerated." The submitted input will be a breakthrough in our ability to provide administrative convenience while maintaining nuclear security and safety." [DPFRZR/Dwiangesti/BHKK/SP/GP]

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Photos and presentations can be downloaded by clicking here.

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