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WHOPAR Guidance for Applicants
(2004; 140 pages)

Guidance note to Applicants (Manufacturers) on the compilation of the WHO Public Assessment Report version 1.0 - December 2004 Appendix 1 - Characteristics of WHOPAR Parts Appendix 2 - Documentation to submit together with the initial submission Appendix 3 - Guidance on Package Leaflet, Summary of Product Characteristics and Labelling ANNEX I - Summary of product characteristics - Word Templates ANNEX III - Labelling and package leaflet - Word Templates ANNEX I - Summary of product characteristics - annotated ANNEX III - Labelling and package leaflet APPENDIX I - Statements for use in Section 4.6 "Pregnancy and lactation" of SPC APPENDIX II - MedDRA terminology to be used in Section 4.8 "Undesirable effects" of SPC APPENDIX III - Standards for required storage standards APPENDIX IV - Terms for batch number & expiry date to be used on outer and/or inner labelling Convention to be followed for EMEA-QRD templates Compilation of QRD decisions on the use of terms Compilation of QRD decisions on stylistic matters in product information Tables of non-standard abbreviations Appendix 4 - Format of the Summary of Product Safety and Efficacy