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
 

Convention to be followed for EMEA-QRD templates

The European Agency for the Evaluation of Medicinal Products

EMEA/QRD/10/01
Version 6.0 - April 2003

This convention must be followed exactly in order to ensure absolute consistency between templates, to avoid discrepancies between language versions and formatting problem when compiling and merging documents.

SOFTWARE:

We recommend the use of WORD 9.0 (Office 2000) or later versions

FONT:

Font: Times New Roman
Size: 11
Font style: Regular
Character spacing: normal

LANGUAGE:

Use the relevant language settings, i.e. European standard spelling and grammar when editing the text, e.g. English (UK); French (France); Portuguese (Portugal); Spanish (Spain-Modern sort); etc.

SCIENTIFIC SYMBOLS:

Insert from the symbol window (normal text), e.g. µ, ¦Á, ½, ¡Ü, ±, etc.

MARGINS:

From top of page: 2.0 cm
From bottom of page: 2.0 cm
From left of page: 2.5 cm
From right of page: 2.5 cm
Gutter: 0 cm
Header: 1.3
Footer: 1.3 cm

TEXT ALIGNMENT:

Left alignment, except for title pages where the text is centred.

LINE SPACING:

Single-line spacing. (0 pt before and after paragraph)

CHARACTER SPACING:

Normal. Between figures and units use non-breaking space (Ctrl + Shift + space): e.g. 10 mg; use also non-breaking hyphen to avoid separation (Ctrl + Shift + -).

INDENTS:

1.0 cm from the left-hand margin for the first indent.

BULLET POINTS:

Left alignment. Text indentation: 1.0 cm from the left-hand margin

PAGE LAYOUT:

Section breaks must be avoided where possible. Do not use line breaks.

TITLE PAGES:

Centred; horizontal position: line 24 (BOLD, CAPITAL LETTERS) Keep title page as per template, e.g. "A. LABELLING"

HEADINGS:

1. HEADINGS (BOLD, CAPITAL LETTERS) (2 lines before and 1 line after the heading)

SUBHEADINGS:

1.1 Subheadings(bold, normal letters) (SPC only) (1 line before and 1 line after the heading)

SUBHEADINGS:

Subheadings (no numbering, bold, normal letters) (Package leaflet only) (1 line before and 1 line after the heading)

Public

7 Westferry Circus, Canary Wharf, London, E14 4HB, UK
Tel. (44-20) 74 18 84 00 Fax (44-20) 74 18 86 70
E-mail: mail@emea.eu.int http://www.emea.eu.int

ADDITIONAL SUBHEADINGS:

Do not use bold or additional numbering in the SPC, instead use underline or Italics or both and be consistent throughout the text, e.g.:

 

Additional subheading:

 

Additional subheading

 

Additional subheading

 

Additional subheading

NUMBERING: (of headings)

Must respect the current template
No additional numbering should be created

BOXED HEADING:

1. HEADING

Boxed headings in Annexes III A (labelling) provide a structure to facilitate the work of applicants, assessors and reviewers etc.; they must remain in the annexes during the whole evaluation procedure. However, they must NOT appear in the final printed packaging materials (e.g. actual carton, container label) or on the mock-ups and specimens.

BRACKETING CONVENTION:

{text} Information to be filled in, normal text;
<text> Text to be selected or deleted as appropriate;

[Green Italic text] Guidance and explanatory notes in annotated English template version (PDF) only.

[Shaded text]

Shaded text can be used by applicant to highlight certain text parts which will not be printed in the actual SPC or label; Its use should be limited.

Example in SPC:

Applicants may present, during evaluation, a combined SPC for different strengths, clearly indicating with a grey-shaded text the strength or presentation to which alternative text elements refer.

Example in SPC:

5.1 Pharmacodynamic properties

Pharmacotherapeutic group: {group}, ATC code: {code} [proposed: under application]

Example in labelling:

7. OTHER SPECIAL WARNING(S), IF NECESSARY

[None] [alternatively leave blank]

Cross-reference:

When cross-referring in the SPC do not mention the section heading but only the section number and be consistent throughout the text
• Example: ……(see section 5.1)

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