Índice de contenido

	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

WHOPAR Guidance for Applicants