CRED SMPC 2024

Pharmacovigilance provisions

Patient information leaflets for medicines subject to additional monitoring (list referenced in Article 23 of Regulation (EC) No 726/2004):

• The black symbol and statement should only appear immediately after the declaration of the name of the medicine.

“▼ This medicine is subject to additional monitoring. This will allow quick identification of new safety information. You can help by reporting any side effects you may get. See the end of section 4 for how to report side effects”

• The black symbol shall be a black inverted equilateral triangle: the symbol shall be proportional to the font size of the subsequent standardised text and in any case each side of the triangle shall have a minimum length of 5 mm.

11

11

Technical (HCP) leaflets

• Must comply with the requirements of the relevant legislation

• Usually the approved SmPC (entire) or

• Relevant parts of the SmPC as tear off portion of PIL (treated as extra-statutory information) e.g., dilution and administration details

12

12

6