Module 6

03/10/2024

Clause 12 Prescribing Information and Other obligatory Information

• Must form integral part of promotional material and be legible, includes:

• Summary of key elements of SmPC i.e. not used verbatim

• Legal classification

• Cost

• Can be via QR code (new in 2024 update)

• In electronic media, available in prominent, single click link

• Always include adverse event reporting mechanism

• Black triangle for products under additional monitoring

• Placed at first mention of name

The Organisation for Professionals in Regulatory Affairs

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Clause 13 Abbreviated Advertisements

• Only allowed in professional publications (not via internet)

• Only small size, limited content

• Exempt from prescribing information

• Still require AE statement and black triangle (if additional monitoring)

The Organisation for Professionals in Regulatory Affairs

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