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
 

ANNEX I - Summary of product characteristics - Word Templates

[Version 6.1, 07/2004]

1. NAME OF THE MEDICINAL PRODUCT

{(Invented) name of product <strength> <pharmaceutical form>}

2. QUALITATIVE AND QUANTITATIVE COMPOSITION

For excipients, see section 6.1.

3. PHARMACEUTICAL FORM

4. CLINICAL PARTICULARS

4.1 Therapeutic indications

<This medicinal product is for diagnostic use only.>

4.2 Posology and method of administration

4.3 Contraindications

<Hypersensitivity to the active substance(s) or to any of the excipients <or {residues}>.>

4.4 Special warnings and special precautions for use

4.5 Interaction with other medicinal products and other forms of interaction

4.6 Pregnancy and lactation

[For Pregnancy and Lactation statements see Appendix I.]

4.7 Effects on ability to drive and use machines

<{Invented name} has <no or negligible influence> <minor or moderate influence> <major influence> on the ability to drive and use machines.> [describe effects where applicable]

<No studies on the effects on the ability to drive and use machines have been performed.>

<Not relevant.>

4.8 Undesirable effects

[MedDRA frequency convention and system organ class database, see Appendix II]

4.9 Overdose

<No case of overdose has been reported.>

5. PHARMACOLOGICAL PROPERTIES

5.1 Pharmacodynamic properties

Pharmacotherapeutic group: {group}, ATC code: {code}

5.2 Pharmacokinetic properties

5.3 Preclinical safety data

<Preclinical data reveal no special hazard for humans based on conventional studies of safety pharmacology, repeated dose toxicity, genotoxicity, carcinogenic potential, toxicity to reproduction.>

<Preclinical effects were observed only at exposures considered sufficiently in excess of the maximum human exposure indicating little relevance to clinical use.>

<Adverse reactions not observed in clinical studies, but seen in animals at exposure levels similar to clinical exposure levels and with possible relevance to clinical use were as follows.>

6. PHARMACEUTICAL PARTICULARS

6.1 List of excipients

6.2 Incompatibilities

<Not applicable.>

<In the absence of compatibility studies, this medicinal product must not be mixed with other medicinal products.>

<This medicinal product must not be mixed with other medicinal products except those mentioned in section 6.6.>

6.3 Shelf life

<...> <6 months> <...> <1 year> <18 months> <2 years> <30 months> <3 years> <...>

6.4 Special precautions for storage

[For Storage condition statements see Appendix III]

6.5 Nature and contents of container

<Not all pack sizes may be marketed.>

6.6 Instructions for use and handling <and disposal>

<No special requirements.>

<Any unused product or waste material should be disposed of in accordance with local requirements.>

7. MARKETING AUTHORISATION HOLDER

{Name and address}

8. MARKETING AUTHORISATION NUMBER(S)

9. DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION

10. DATE OF REVISION OF THE TEXT

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