STEP II: risk assessment
The second phase of the evaluation process focused on factors that could affect safe use of the various products during routine use by patients.
The process was divided into two separate but related elements:
- Critical information (labelling, packaging, storage conditions, blisters and patient information leaflets)
- Added value (calendar packs, European Article Number (EAN) barcode, pack size, tablet/capsule colouring and marking and label instruction space)
A pro forma developed by the Northern Ireland Regional Medical Governance Team was used to score the information received for the elements identified in this step. Product lines were only accepted if they met the criteria set out in the critical information step.
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