Market Authorization Holders handling Borderline Products should comply with the following criteria for Schedule IIB Special Category
- The statement "Prescription Only" should be included on the Product Label and Patient Information Leaflet (PIL)
- The statement "Dosage as directed by the physician" should be included in the PIL
- The Patient Information Leaflet (PIL) should be revised in accordance with the applicable Summary of Product Characteristics (SmPC)
- Prescribers' information should be included in the PIL as a separate section.
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