IR1 - Licence to manufacture, possess for sale or deal in irradiating apparatus or radioactive materials
The IR1 Licence to manufacture, possess for sale or deal in irradiating apparatus or radioactive materials is issued by the National Environment Agency (NEA) in Singapore. It is required for entities involved in the handling of radioactive materials and has a perpetual validity with annual payments. Processing typically takes 20 working days upon complete submission.
- Validity
- Perpetual (with recurring annual payment)
- Processing time
- 20 working days (excluding inspections), upon receipt of complete and accurate submission of all required documents
- Issuing authority
- NATIONAL ENVIRONMENT AGENCY (NEA)
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Who needs the IR1 - Licence to manufacture, possess for sale or deal in irradiating apparatus or radioactive materials
This licence applies to Singapore businesses registered under the following SSIC industry codes:
- Required to operateDivision 26 — MANUFACTURE OF COMPUTER, ELECTRONIC AND OPTICAL PRODUCTS
Includes: 26111 Manufacture of discrete devices, 26112 Semiconductor wafer fabrication, 26113 Assembly and testing of semiconductors, 26114 Manufacture of solar wafers
- Required to operateDivision 21 — MANUFACTURE OF PHARMACEUTICALS AND BIOLOGICAL PRODUCTS
Includes: 21011 Manufacture of pharmaceutical intermediates and fine chemicals for human use, 21012 Manufacture of pharmaceutical products and preparations for human use, 21013 Manufacture of pharmaceutical products for veterinary use, 21021 Manufacture of vaccines for human use
What's involved in getting the IR1 - Licence to manufacture, possess for sale or deal in irradiating apparatus or radioactive materials
The scope of the application — what must be in place, how the agency reviews, and where applications typically stall.
To apply for the IR1 Licence, follow these steps:
Application Channel
The application is submitted via the GoBusiness Dashboard, which is the official platform for Singapore licences.
Prerequisites
Before applying, ensure you have the following documents prepared:
- Irradiating apparatus / radioactive material information: Details about the materials you will be handling.
- Brochures, catalogues, data sheets: These should show the technical specifications of the apparatus or radioactive materials.
- Floor plan / Site layout: Required for the storage or manufacture of radioactive materials.
- Radiation Protection Plan (RPP): This plan must include relevant Standard Operating Procedures (SOP) covering waste management, disposal/decommissioning, and emergency response plans.
- Disposal plan: For radioactive materials, include a plan for disposal and any official documents stating that the overseas manufacturer/supplier will accept the return of disused sources.
- Acknowledgement for acceptance of disused sources: An official document stating your organization will accept the return of disused sources for repatriation.
- HSA authorisation: If your application includes medical devices or therapeutic products, provide the HSA Medical Device Registration or proof of exemption from registration.
Post-Submission Steps
Once you have submitted your application, the NEA will review the documents. The processing time is approximately 20 working days, excluding any inspections. Ensure that all documents are complete and accurate to avoid delays.
Required documents and prerequisites
Items the applicant typically needs ready before submitting:
- Irradiating apparatus / radioactive material information
- Brochures, catalogues, data sheets, etc. showing the technical specifications of the apparatus or radioactive material
- Floor plan / Site layout
- For storage or manufacture of radioactive materials, please provide the floor plan and layout of the storage / installation site.
- Radiation Protection Plan
- For storage or manufacture of radioactive materials, please provide Radiation Protection Plan (RPP) and relevant Standard Operating Procedures (SOP). These should include waste management, disposal/decommissioning plan and emergency response plans, where applicable.
- Disposal plan
- For radioactive materials, please provide the disposal plan and where applicable, official document(s) stating that the overseas manufacturer / supplier can and will accept the return of disused sources for proper disposal.
- Acknowledgement for acceptance of disused sources
- For radioactive materials, please provide the official document to your customers stating that your organisation will accept the return of disused sources for repatriation to country of origin.
- HSA authorisation for medical devices/therapeutic products
- For applications including medical devices or therapeutic products, please provide the HSA Medical Device Registration or proof of exemption from registration.
IR1 - Licence to manufacture, possess for sale or deal in irradiating apparatus or radioactive materials FAQ
Can a foreign-owned company apply for the IR1 Licence?
Yes, foreign-owned companies can apply for the IR1 Licence in Singapore, provided they meet all the necessary prerequisites and documentation requirements outlined by the National Environment Agency.
What happens if I operate without the IR1 Licence?
Operating without the IR1 Licence can lead to severe penalties, including fines and legal action by the National Environment Agency. It is crucial to obtain the licence before engaging in any activities involving irradiating apparatus or radioactive materials.
Is this licence required if I only operate online?
Yes, the IR1 Licence is required regardless of whether your operations are conducted online or offline, as it pertains to the handling of irradiating apparatus or radioactive materials.
Does this apply to home-based businesses?
The IR1 Licence is generally not applicable to home-based businesses unless they are involved in the manufacture, possession, or sale of irradiating apparatus or radioactive materials. Such activities typically require a dedicated facility.
How long is the renewal process compared to the first application?
The IR1 Licence has a perpetual validity with recurring annual payments. Renewal processes may be simpler than the initial application, but it is essential to maintain compliance with all regulations and submit any required documentation on time.
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