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. This licence is required for businesses involved in the handling of such materials and is valid perpetually, with an annual payment. Processing typically takes 20 working days upon receipt of complete documentation.
- 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.
What this licence allows the business to do
The IR1 Licence enables businesses in Singapore to manufacture, possess for sale, or deal in irradiating apparatus or radioactive materials. This is crucial for companies involved in sectors such as healthcare, research, and industrial applications where such materials are utilized.
What must be in place before the licence can be granted
Before the licence can be granted, several prerequisites must be established. These include detailed information on the irradiating apparatus or radioactive materials, technical specifications through brochures or data sheets, and a comprehensive floor plan or site layout. For businesses involved in the storage or manufacture of radioactive materials, a Radiation Protection Plan (RPP) and relevant Standard Operating Procedures (SOP) must also be prepared. Additionally, a disposal plan for radioactive materials is required, along with documentation confirming the acceptance of disused sources for proper disposal.
How the agency reviews and decides
The National Environment Agency (NEA) conducts a thorough review of the submitted documentation. This includes evaluating the Radiation Protection Plan and ensuring that all safety measures are in place. The agency may also arrange for inspections to verify compliance with safety and operational standards before granting the licence.
Common reasons applications stall
Applications for the IR1 Licence can experience delays for several reasons. Common issues include incomplete documentation, such as missing technical specifications or inadequate safety plans. Additionally, discrepancies in the floor plan or site layout can lead to complications. Ensuring that all requirements are met and that documentation is thorough can help prevent these 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
Do I need this licence to start operating?
Yes, if your business involves the manufacture, possession for sale, or dealing in irradiating apparatus or radioactive materials, obtaining the IR1 Licence is essential before commencing operations.
What can my business do once licensed?
Once licensed, your business can legally manufacture, possess for sale, or deal in irradiating apparatus or radioactive materials, enabling you to operate in sectors such as healthcare, research, and industrial applications.
What happens if I operate without it?
Operating without the IR1 Licence can lead to severe penalties, including fines and legal action. It is crucial to comply with licensing requirements to avoid operational disruptions and legal issues.
What's the most common reason applications get rejected?
The most common reason for rejection is incomplete or inaccurate documentation. Ensuring that all required materials, such as technical specifications and safety plans, are thoroughly prepared can significantly improve the chances of approval.
Can a foreign-owned company hold this licence?
Yes, foreign-owned companies can apply for the IR1 Licence in Singapore, provided they meet all the necessary requirements and regulations set forth by the National Environment Agency.
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