RER/9/096 Regional Planning Meeting “Strengthening National Infrastructures for the Control of Radiation Sources” (TSA-1), (Phase II) Country: Republic of Macedonia March 2009 IAEA, Vienna

Legislation Regulations and Guidance occupational protection, public protection, medical exposure, radioactive waste, and the transport of radioactive materials. Brief update  2008 drafting regulations envisaged by the Amendments of the Law on ionizing radiation protection and safety (135/07) in order of complete harmonization with the International Safety Standards  Report from TAIEX mission for reviewing draft regulation (November 2008): Generally compliance with international standards Weak points: Lack of new regulation - currently into force are old regulations, not totally financial independence – budget is a subprogram of the Ministry of Health’s program Strong points: Drafted new regulations – to be adopted by the end of 2009

Radiation Safety Directorate Duties of RSD: Issuing and revoking licenses, National registry of ionizing sources, inspections and enforcements, issuing regulations and guidance, cooperation with national and international authorities, ensuring proper training of radiation workers, establishing appropriate mechanism to inform the public, undertaking measures in a case of radiological emergency etc. Strong points: Independent regulatory body, Advisory Body – Radiation Safety Commission; Weak points: Not totally financial independence – the RSD’s budget is a subprogram of the Ministry of Health’s program in state budget Funding: National (state budget) DIRECTOR Sector for General and Legal Affairs Unit for Legal Affairs and International Cooperation Unit for Financial Affairs and IT Sector for licensing, Monitoring, Emergency and Inspection Unit for Licensing, Monitoring and Emergency Unit for Inspection Unit for human Resources management Unit for Internal audit

Radiation Safety Directorate: Staffing and Training Human resources of the RSD  Director and 14 employees Education, skills, training and training needs  5 physicists, 1 mechanical engineer, 1 lawyer, 1 IT engineer, 1 roentgen technologist, 3 agriculture engineers, 1 economist, 1 junior referent for technical support  Participating of the regulatory staff in training courses, workshops, conferences, technical meetings organized by the IAEA, US, gaining skills in different areas of radiation protection and safety  Needs of additional trainings

Notification - Authorization – Licensing - Inspections Main activities  October 2008: electronic system application and issuing licenses for import, export and transit of radioactive sources (EXIM)  RSD issues licences for import of X-ray units Strong points:  Procedure of issuing licenses regulated (based) by general rules - Law on administrative procedure Weak points  Lack of regulation for specific requirements for the procedure of issuing licenses – prepared draft version of a such regulation  Lack of guidance for authorization and inspection for different practices Reasons for weaknesses of the system of authorization-licensing & inspection  Not enough regulatory staff, need for preparing many documents and relatively short time of the Directorate’s establishment Enforcement – effectiveness – problems – constraints  Inspection responsibility to order remediation of certain non-compliances with the Law  Penalty provisions envisaged in the Law (48/02 and 135/07)

Management System Recent developments concerning: Information management Web site of the Directorate, communication with media Quality management  In the RB - RSD, there is: Unit for Internal Audit (according to the Regulation On the Internal Organization) with following duties:  to assess whether the functioning of the RSD is in accordance with the Laws, Regulations and Internal Acts;  to check economically, effectiveness and efficacy of the functions of the RSD;  to follow conducting of undertook measures by the Unit’s heads according the audit’s reports and etc.

A SWOT Matrix Strengths Independent RB – the RSD; Advisory Body – Radiation Safety Commission; RSD - Member of the National Coordination Centre on Border Management Weaknesses Insufficient budget; Radioactive waste management; Lack of internal procedures; Chronic exposure, remediation, and decommissioning. Lack of guidance and codes of practice. Proposed Actions IAEA Expert mission for reviewing draft regulations; Adoption of the prepared regulations; Training of border police officers for combat illicit trafficking; Training of radiation protection officers Needs Drafting new regulations, issuing guidance, codes of practice and internal procedures, trainings of regulatory staff, preparing Strategy of training of radiation workers, management with radioactive waste and establishment National central storage of radioactive waste, strengthening the combat of illicit trafficking Opportunities Improvement of National infrastructure by participating in IAEA, EU and other regional projects. Threats