Info

Voluntary Nationwide reporting to national centre, major hospitals operate additional ADR monitoring systems and submit them to the national centre

Mandatory Reporting by health professionals to regional centre (31 regional hospital-based centres), compiled at national centre, reporting by marketing authorisation holders to national centre

Procedure for assessment of ADR cases and other data and decision-making for nationally authorised medicinal products

Main tool of communication of safety information to healthcare professionals/ general public

Case assessment by single expert of Press releases national centre and advisory committee, routinely recommendations on regulatory action published in by advisory committee (meets 4x/year) professional journals

Case assessment and recommendations Monthly by advisory committee (meets bulletin for

2-4x/month) to medicines commission health which proposes regulatory action professionals, press releases

Case assessment by single expert of Press releases national centre, sometimes by ADR and advisory committee, recommendations publications in on regulatory action by ADR advisory scientific committee (meets 1x/month) and journals medicines licensing committee

Case assessment by single expert and Bi-monthly minor regulatory action by national drug bulletin for centre, recommendations on major health regulatory action by committee on safety professionals, and efficacy press releases

Case assessment by single expert at Press releases regional centre, signal generation and further assessment by national centre, signal evaluation on causal relationship by advisory committee (meets every second month), validation of their opinion by technical committee, recommendations on regulatory action by national commission, sometimes validated by the marketing authorisation commission

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