CRED SMPC 2024

17/09/2024

SmPC appendices

Appendix I : Statements for use in Section 4.6 “Pregnancy and lactation” of SmPC

Appendix II: MedDRA terminology to be used in section 4.8

Appendix III: Storage conditions

Appendix IV: Terms/abbreviations for “batch number” and “expiry date” to be used on the labelling of human medicinal products Appendix V: List of details of the national reporting systems to communicate adverse reactions (side effects) for use in section 4.8 “Undesirable effects” of SmPC and section 4 “Possible side effects” of package leaflet

The Organisation for Professionals in Regulatory Affairs

51

QRD and other EMA reference documents

QRD convention to be followed for the EMA-QRD templates

Compilation of QRD decisions on stylistic matters in product information

Compilation of QRD decisions on the use of terms

QRD recommendations on the expression of strength in the name of centrally authorised human medicinal products (as stated in section 1 of SPC, and in the name section of labelling and PL)

Tables of non-standard abbreviations

Annex to the European Commission guideline on ‘Excipients in the labelling and package leaflet of medicinal products for human use’ QRD general principles regarding the SmPC information for a generic/hybrid/biosimilar product

The Organisation for Professionals in Regulatory Affairs

52