Certificates and Permits
Overview Authorizations and approvals issued by AERA
AERA through the Authorization and Compliance Division issues licenses, permits and other regulatory approvals to ensure that activities involving radioactive materials are conducted safely and related facilities are operated in compliance with requirements of the Atomic Energy Act and applicable regulations under the Act. The issued license certificates and permits have different validity periods and issuance conditions based on purpose related and safety and security objectives The issuance of licensing certificates and permits ensures that AERA is committed to providing a transparent, efficient and risk-informed authorization process that supports the peaceful use of technologies involving radiation sources in Malawi. All authorizations are issued based on established regulatory requirements to protect people and the environment from hazardous radiation exposures
Certificate Types Available Regulatory Authorizations
Cross-Border Import and Export Licence AERA issues licenses to authorize the importation into or exportation from Malawi of radioactive materials, equipment containing radioactive sources and radiation generating equipment. License is issued following a regulatory assessment to verify compliance with applicable standards including safety and security requirements. This ensures that all cross-border movements of the items conform to requirements for protection of people and the environment
Safe Operations Possession and Use Licence Possession and use of radioactive materials or equipment containing radioactive sources must only be under AERA issued licences. AERA also licenses the use of all high-energy radiation-generating equipment with low-energy radiation-generating equipment requiring to be registered as a form of regulatory authorization. All authorizations ensure safe, secure and compliant use of radiation sources and equipment through issuance of appropriate conditions for managing associated radiological risks
Resource Extraction Mining and Processing Licence A mining and processing licence authorizes mining, processing and other related activities involving radioactive minerals such as uranium. Rare earth minerals mining operations with significant radiological aspects due to presence of naturally occurring radioactive materials must also complete relevant AERA licensing processes. Licensing ensures that appropriate radiation protection, environment management and waste management requirements are implemented throughout the lifecycle of operations
Safe Transport Radioactive Material Transport Licence A transport licence authorizes the transport of radioactive materials within, into, through or out of Malawi. The licence is issued to ensure that the packaging, handling, storage in transit and movement of radioactive materials comply with regulatory requirements for radiation safety and security of radioactive materials including applicable international transport standards. This ensures transport activities consider protection of transport workers, the public, and the environment
Cancer Treatment Radiotherapy Facility Licence Operation of radiotherapy facilities requires licensing by AERA. The licensing process includes all stages of establishment of facilities from approval of proposed site, facility design, approval of construction plans and activities, and final authorization to operate. Licence issuance follows verification that facility establishment and operation comply with requirements for radiation safety and security of radioactive sources to protect patients, workers, the public and the environment
Safety Clearance Radiological Clearance Certificate Certification of absence of radiological contamination confirms that imported food products, vehicles and other specified materials have been assessed and comply with established radiological contamination limits. The certificate provides assurance that the items do not present an unacceptable radiological risk and may be imported, distributed or used in accordance with applicable regulatory requirements. The certification is implemented in collaboration with relevant government agencies
Facility Closure Decommissioning Authorization A decommissioning authorization from AERA is required before the permanent shutdown, commencing dismantling of a facility or practices involving radioactive materials or radiation sources. The authorization ensures that decommissioning is planned and implemented in accordance with approved procedures. This enables implementation of appropriate measures for radiation protection, radioactive waste management, environmental protection and the safe release of the site from regulatory control
Process Process for issuance of certification
1. Submission of notification Applicants intending to undertake activities involving radiation sources or radioactive materials must first notify AERA. This enables the Authority to determine applicable regulatory requirements and guide applicants through the appropriate certification process 2. Completing Applications Following notification, AERA issues the appropriate application forms and guidance documents. Applicants must provide complete information on the proposed facility, equipment, personnel, safety arrangements, and operational activities to demonstrate readiness for regulatory review and authorization 3. Technical Review and Safety Evaluation AERA reviews each application and supporting safety documents to verify that radiation protection measures, security arrangements, operational procedures and emergency plans comply with the Atomic Energy Act and international radiation safety standards 4. Pre-Authorization Inspection and Verification AERA may conduct on-site assessments before issuance of certification to verify submitted information. Inspectors assess facilities, equipment, safety systems, and operational readiness to confirm that all regulatory requirements have been accurately represented and can be effectively implemented 5. Issuance of Certification and attached Conditions Where all requirements are met, AERA issues the relevant certification with applicable conditions. Certificate holders must comply with these conditions throughout the certification period to ensure continued safety, security, regulatory compliance and environmental protection 6. Regulatory Decision and Feedback If an application does not meet regulatory requirements, AERA may refuse certification. Applicants are informed of the reasons and may be required to address deficiencies, provide additional information or implement corrective measures before reapplying
Certification Exemptions Exempted Radiation Sources and Practices
Exemption Levels Practices and sources below prescribed exemption levels AERA may exempt specified radiation sources or practices from certification if they comply with the exemption criteria and levels established by the Authority. These are based on radionuclide activity or activity concentration and are intended only for practices presenting negligible radiological risk
Approved Sealed Sources Approved apparatus containing sealed radioactive sources AERA may exempt specified apparatus containing radioactive material if certain conditions are met. This can be when it is a type approved by the Authority, the radioactive material is in the form of a sealed radioactive source that under normal operating conditions specified dose and rate does not exceed levels specified by the Authority
Excluded Activities Exposures and activities not requiring regulation Certain activities and exposures lie outside the scope of regulatory control. These include cosmic radiation, unmodified concentrations of naturally occurring radionuclides in raw materials and other radiation sources determined by the Authority to be essentially not amenable to regulatory control. Activities involving exposures excluded from regulatory control through regulations and sources of non-ionizing radiation are also exempted
What Next? Maintaining Compliance After Certification
1. Compliance verification inspections AERA conducts planned or unannounced inspections to verify continued compliance with the conditions of the certificate and applicable regulatory requirements 2. Monitoring and Surveillance AERA monitors certified activities through reviews, environmental monitoring, audits, checking of performance indicators or other oversight measures to ensure ongoing radiation safety and security of radioactive sources 3. Record Maintenance and Regulatory Review Maintain up-to-date records of certified activities and periodic review of certification information is done to support regulatory planning, inspections and decision-making
Frequently Asked Questions Common questions on certification
The section provides quick answers to common enquiries about certifications, permits and other regulatory authorizations issued by AERA. This is intended to help to provide clarity on regulatory requirements and the certification process The information helps provide general guidance. Where additional clarification is required, AERA may be contacted for advice relevant to particular circumstances • What is a certificate or permit issued by AERA A certificate or permit is an official authorization issued by AERA confirming that an individual, organization, product, material or activity complies with the Atomic Energy Act and applicable regulations. It may be required before a regulated activity can commence or continue • How do I know if I need a certification or permit A certificate or permit may be required for activities involving radiation sources, radioactive materials, radiation equipment, transport, import or export, or radiation-related services. Contact AERA for guidance before commencing any regulated activity • How do I apply for a certification or a permit It is recommended to contact AERA so that the appropriate forms to be completed together with the required supporting documentation are explained with the applicable fees • How long does it take to process an application for certification or issuance of a permit Processing times depend on the type of certificate or permit, the complexity of the application and the completeness of submitted information. Submit all required documents and respond promptly to requests for additional information to avoid delays • Can a certification or permit be amended, renewed or transferred Yes. Depending on the type of certification or permit, holders may apply for renewal before expiry or request amendments where there are significant changes. Certifications and permits are not transferable to another person or organization without prior written approval from AERA • What happens if I undertake a regulated activity without the required certification or permit Conducting a regulated activity without the required authorization violates the Atomic Energy Act. AERA may issue compliance notices, suspend activities, impose administrative sanctions or initiate legal proceedings, depending on the nature of the non-compliance