CHARACTER SPACING: To avoid separation in the text and between figures and units use:
- Non-breaking space (Ctrl + Shift + space): e.g. 10 mg
- Non-breaking hyphen (Ctrl + Shift + hyphen): e.g. 100
-200
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.
TITLE PAGES: Centred, line 24 (BOLD, CAPITAL LETTERS).
Keep title page as per template, e.g. “A. LABELLING”
HEADINGS: 1. HEADINGS (BOLD, CAPITAL LETTERS)
(2 single lines before and 1 single line after)
SUBHEADINGS: 1.1 Subheadings (bold, normal letters)
(SmPC only) (1 single line before and 1 single line after)
SUBHEADINGS: Subheadings (no numbering, bold, normal letters)
(package leaflet only) (1 single line before and 1 single line after)
ADDITIONAL
SUBHEADINGS: In the SmPC, do not use bold or additional numbering, instead use
underline or italics or both and be consistent throughout the document,
e.g.:
Additional subheading
Additional subheading
Additional subheading
Additional subheading
HEADINGS
NUMBERING: Must respect the current template. No additional numbering should be
created. Do not use automatic numbering insertion.
BOXED HEADINGS:
1. HEADING
Boxed headings in Annex 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.
Boxed headings should be created by using “outside borders” and not by
inserting a table.
Boxed headings should always be kept, even when not applicable
.
SCIENTIFIC SYMBOLS: Insert from the symbol window (normal text), e.g. μ, α, ½, ≤, ±, etc. Do
not use AutoCorrect to automatically insert symbols that are included in
the built-in list to ensure that the symbols are always readable.
TABLES: Font: in case the table is too big to fit in the page, a slightly smaller font
size may be accepted on a case by case basis, as long as readability is
maintained.
Borders: single line style, colour automatic, width 1/2 pt.
Do not use background or shading.
CROSS-REFERENCE: When cross-referring in the SmPC, do not mention the section heading
but only the section number and be consistent throughout the text.
Examples: … (see section 5.1)
… (see sections 5.1 and 5.3)
QRD convention to be followed for the EMA-QRD templates
EMA/62470/2007 Page 2/3