WHOPAR Guidance for Applicants
(2004; 140 pages)
Table of Contents
View the documentGuidance note to Applicants (Manufacturers) on the compilation of the WHO Public Assessment Report version 1.0 - December 2004
View the documentAppendix 1 - Characteristics of WHOPAR Parts
View the documentAppendix 2 - Documentation to submit together with the initial submission
Close this folderAppendix 3 - Guidance on Package Leaflet, Summary of Product Characteristics and Labelling
View the documentANNEX I - Summary of product characteristics - Word Templates
View the documentANNEX III - Labelling and package leaflet - Word Templates
View the documentANNEX I - Summary of product characteristics - annotated
View the documentANNEX III - Labelling and package leaflet
View the documentAPPENDIX I - Statements for use in Section 4.6 "Pregnancy and lactation" of SPC
View the documentAPPENDIX II - MedDRA terminology to be used in Section 4.8 "Undesirable effects" of SPC
View the documentAPPENDIX III - Standards for required storage standards
View the documentAPPENDIX IV - Terms for batch number & expiry date to be used on outer and/or inner labelling
View the documentConvention to be followed for EMEA-QRD templates
View the documentCompilation of QRD decisions on the use of terms
View the documentCompilation of QRD decisions on stylistic matters in product information
View the documentTables of non-standard abbreviations
View the documentAppendix 4 - Format of the Summary of Product Safety and Efficacy
 

Appendix 3 - Guidance on Package Leaflet, Summary of Product Characteristics and Labelling

Guidance documents on the Package Leaflet, Summary of Product Characteristics and Labelling are listed below and attached for immediate reference. The documents are essentially as published by the EMEA. Since these documents are subject to regular updates interested parties are advised to consult the EMEA Quality Review of Documents (QRD) web pages as appropriate21, 22.

21www.emea.eu.int/htms/human/qrd/qrdintro.htm
22www.emea.eu.int/htms/human/qrd/qrdtemplate.htm

 

Guidance documents to consult include: Templates:

1.

Annex I

Summary of Product Characteristics (template)

File 01…23

 

Annex III

A. Labelling (template)

 
   

B. Package Leaflet (template)
This is a Word version, which is directly usable as a template to start developing the documents.

 

2.

Annex I, III

Same as 1 above, annotated.

File 02…

3.

Appendix I

Statements for use in Section 4.6 "Pregnancy and lactation" of Summary of Product Characteristics

File 03…

4.

Appendix II

MedDRA terminology to be used in Section 4.8 "Undesirable effects" of the Summary of Product Characteristics

File 04…

5.

Appendix III

New standards for required storage statements

File 05…

6.

Appendix IV

Terms for Batch number and Expiry date

File 06…

 

23 File references refer to guidance files in the subdirectory 'Ref docs App 3 - QRD'


QRD support documents:

1.

Convention to be followed for EMEA-QRD templates

File 10…

2.

Compilation of QRD decisions on the use of terms

File 11…

3.

Compilation of QRD decisions on stylistic matters in product information.

File 12…

4.

Tables of non-standard abbreviations

File 13…

to previous section
to next section
 
 
The WHO Essential Medicines and Health Products Information Portal was designed and is maintained by Human Info NGO. Last updated: December 1, 2019