Spring Intro 2023

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

15

15

Labelling requirements (1/3)

1. Name of medicinal product i.e. licensed product name (section 1 of SmPC) immediately followed by common name(s) of up to three active substances

2. Statement of active content (per dosage unit)

3. List of excipients (if applicable)

4. Pharmaceutical form and contents of pack

5. Method and route of administration

6. Special warning to “store out of the sight and reach of children”

16

16

8