QRD Appendix III to the Quality Review of Documents templates for human medicinal products
QRD Appendix V - Adverse-drug-reaction reporting details
QRD Appendix II - Medical Dictionary for Regulatory Activities terminology to be used in section 4.8 'undesirable effects' of the summary of product characteristics (Cover page)
QRD Appendix II - Medical Dictionary for Regulatory Activities terminology to be used in section 4.8 'undesirable effects' of the summary of product characteristics
Names of the European Union / European Economic Area countries
Tables of non-standard abbreviations to be used in the summary of product characteristics
List of official languages per country
QRD Appendix III to the Quality Review of Documents templates for human medicinal products (Cover page)
EMEA-003318-PIP01-22
EMEA-001484-PIP01-13-M01