View Procedure
| Procedure Name | Registration as an Importer of Radioactive Materials / Sources or Equipment containing Radioactive Materials / Sources |
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| Description |
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Category
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Registration Requirement
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Responsible Agency
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Sri Lanka Atomic Energy Regulatory Council
Address: No. 977/18, Kandy Road, Bulugaha Junction, Kelaniya, Sri Lanka
Phone: +94 11 2987860
Email: officialmail@aerc.gov.lk
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Legal base of the Procedure
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Sri Lanka Atomic Energy Act no 40 of 2014
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Processing time
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15 days
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Required Documents
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No.
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Type of documents
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1
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Licence or approval given by the competent authority of country of manufacturer of radioactive material for production of radioactive materials (This is required only for radioactive material used for in vivo use of patients)
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2
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Certificate issued by the competent authority / responsible organization of the country of origin of quality of the radioactive material / radiation source imported. (This is required for the material imported for diagnosis & therapy).
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3
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Approval issued by the competent authority that the products / radioactive materials is suitable for diagnostic / therapeutic procedures.(This is required for the material imported for diagnosis & therapy)
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4
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Approval issued from relevant authority for exportation of the products/radioactive materials.
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5
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List of other institutes (local or foreign) that already used the above product/radioactive material.
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| 6 |
Copies of licence to import medicine and certificate of registration medicine issued by the National Medicines Regulatory Authority (NMRA), Sri Lanka (This is required only for radioactive material used for in vivo use of patients) |
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7
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Copy / ies of licence/s issued to the user / s.
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8
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A letter from each user.(If radioactive materials / radiation sources are imported for use under Department of Health, a letter from Director General of Health Services should be attached).
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| 9 |
If a sealed source is imported, letters from the user, supplier / manufacturer and the agent stating that they undertake to return back the source to manufacturer for disposal should be attached. Name of the party which is responsible to bare the expenses in connection with sending the source back to supplier should also be mentioned.
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| 10 |
A copy of the plan approved by the Council along with a letter from the Head of the Institute stating that the construction of the room is completed as per the approved plan and the source to be imported, will be installed in the approved plan. |
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11
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If the sources to be imported are already available, explain why the sources already available cannot be used for the intended purpose. (Applicable for long lived sealed & unsealed sources: ie. half-lives> 5 years).
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| 12 |
If a sealed source is imported, the sealed source certificate, package design certificate/package details & special form certificate (if applicable) issued by the country of origin, should be submitted. |
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| 13 |
Copy of the Business Registration Certificate of importer (This will not applicable to Government Institutes) |
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14
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If the radioactive material / source to be imported associated with an equipment / machine,
- Type approval certificate or similar document acceptable to the Council of the equipment containing radioactive material / source issued by the competent authority of the country of manufacture.
- Operation & technical manual of the machine / equipment issued by the competent authority / manufacturer / responsible organization of the country of origin.
- Details on safety features provided to the equipment / machine to optimize radiation safety of personnel. (Both patients & workers for if equipment / machine is for medical use).
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Process Steps
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Step 1
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Applicant should submit a duly filled application form together with aforesaid required documentation and forward it addressed to the Director General of Sri Lanka Atomic Energy Regulatory Council.
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Step 2
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Atomic Energy Regulatory Council reviews application and if it’s not complete informs applicant .
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Step 3
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Decision taken by Sri Lanka Atomic Energy Regulatory Council on the application is conveyed to the applicant within 15 working days on receipt of all requested information to assess the application.
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| Category | Import |
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The following form/s are used in this procedure
This procedure applies to the following measures
| Name | Measure Type | Agency | Description | Comments | Legal Document | Validity To | Measure Class |
| Requirement for registration of Importer of Radioactive Materials / Sources or Equipment containing Radioactive Materials / Sources | Registration Requirement | | Safe Handling, Import, Export of any and all radioactive materials are done through the Sri Lanka Atomc Energy Regulatory Council. | It has become necessary to permit the beneficial and peaceful applications of nuclear science and technology in health, industry, environment and agriculture, for national development within Sri Lanka. It has become necessary to provide for adequate protection of individuals, society and the environment now and in the future, against the potentially harmful effects of ionizing radiation and for the safety and security of radiation sources, by the establishment and maintenance of a regulatory control system, including the adoption of standards, licensing system, inspection and enforcement to govern all practices involving ionizing radiation.The Sri Lanka Atomc Energy Regulatory Council was estabished for this purpose. | Sri Lanka Atomic Energy Act No. 40 of 2014 | 31-12-9999 | Good |
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