XVI.App1.1. Summary of product characteristics

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XVI.Appendix 1

According to the legislation [DIR Art 8(3)(j), DIR Art 11, REG Art 6(1)] and the Guideline on Summary of Product Characteristics25 , the summary of product characteristics (SmPC) (see GVP Annex I) presents information relevant to RMM in:

  • SmPC section 4.8 ‘Undesirable Effects’: Information on adverse reactions, including information characterising the reaction which may be useful to prevent, monitor or manage its occurrence;
  • SmPC section 4.4 ‘Special Warnings and Precautions for Use’: Warnings and actions to be taken to avoid specific possible adverse reactions or to be taken if a specific reaction occurs or, if deemed necessary, actions to be taken as a precaution for potential risks;
  • SmPC section 4.6 ‘Fertility, Pregnancy and Lactation’: Information on risks of the medicinal product impacting on fertility, pregnancy and lactation, including risks for the embryo/foetus/child due to adverse effects at conception, in utero or through breastfeeding, and actions to be taken to avoid or minimise these risks;
  • SmPC sections 4.1 ‘Therapeutic Indications’, 4.2 ‘Posology and Method of Administration’, 4.3 ‘Contraindications’, 4.5 ‘Interaction with Other Medicinal Products and Other Forms of Interaction’, 4.7 ‘Effects on Ability to Drive and Use Machines’ and 4.9’ Overdose’: Safe use advice regarding indications, dosing and administration, contraindications, interactions, ability to drive and use machines, and overdose.

For medicinal products with additional RMM materials, according to the Guideline on Summary of Product Characteristics26 and supplementary Guidance on Frequently Asked Questions on SmPC Section 4.427, the SmPC section 4.4. should describe the intended actions for risk minimisation and should include a statement on the educational/safety advice materials addressed to healthcare professionals or patients which clearly and succinctly explains the purpose (e.g. “to be handed out to the patient”) and scope of the materials. Other SmPC sections may also refer to these materials if necessary.

XVI.App1.1.1. Boxed warning in bold font type

The SmPC section 4.4 may, in exceptional cases, include especially important safety information in bold type within a box (see Guideline on Summary of Product Characteristics28).