On

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 at Press releases national centre, sometimes by advisory routinely committee, recommendations on published in regulatory action by advisory committee professional

(meets at least every second month) journals ffi

Case assessment by single expert at Press releases national centre and an advisory and committee, recommendations on publications in regulatory action by pharmacovigilance scientific committee (meets 1-2 x/month) journals

Case assessment and signal generation at Drug bulletin national centre, further assessment and for health recommendations on regulatory action professionals by committee on drug usage and adverse reactions (meets 2 x/month)

Case assessment by single experts at Drug bulletin national centre, further assessment and for health recommendation on regulatory action by professionals national drug committee (meets 1 x/week) and higher health council (meets 1 x/month)

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