If You Must Follow the QRD Template to Translate

New to pharmaceutical translations? Read this first.

You may have a fresh assignment on your hands and little time to get acquainted with pharma translations ins and outs. This post aims to provide you with critical information to consider before submitting a translation to your client. It is not comprehensive and if you plan to keep translating for the pharmaceutical industry, it is a good idea to read more than just this post (in fact, a lot more). But this post will certainly be enough to get you started on the right path.

One thing that you should consider before you start to translate is that the original document that you have been sent for translation -usually the English version of the product information- may not be QRD compliant. If your client expects a QRD compliant translation, as is usually the case, they should provide a QRD compliant original – or else you can charge more for having to apply formatting not present in the original. If you were provided with a QRD compliant copy and you returned a non-QRD compliant translation, do better next time. The QRD template is not terribly difficult to make sense of.

QRD compliance is expected at both central level, for medicines reviewed by EMA, and at the national level, for medicines reviewed by individual European Economic Area member states. The templates are different, so be sure to clarify which template you need to follow before you get to work. Otherwise you risk having to waste time redoing your work. Note that in the European Economic Area there are also templates in place for veterinary medicines, so again, be sure to know what is required of you before you get to work.

QRD Formatting Essentials

Please follow these conventions strictly:

BRACKETING CONVENTION USED IN THE TEMPLATES

{text}

Information to be filled in, i.e. normal text. Remove the curly brackets when you are done filling in text.

<text>

Text to be selected or deleted as appropriate. That is, either you take it *as it is provided in the template*, or if it is not contextually valid, you remove it. Remove the text if it is not pertinent, or keep relevant parts, but in either case you have to delete the angled brackets. Do not write free text, only use the one provided if necessary.

[Green text]

Guidance and explanatory notes only. To be deleted when using the templates. Your final submission should not contain any of these green notes. Do not translate them, they are FYIs, and no more.

PAGE SET-UP

PAGE LAYOUT

Section breaks must be avoided. Line breaks or page breaks should only be used if necessary.

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

FONT

Font: Times New Roman
Size: 11
Font style: Regular
Character spacing: Normal
Font colour: Black Automatic (i.e. the text throughout the annexes should be presented in black automatic font, including figures, tables, pictograms, etc.).

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.

A good rule of thumb when working in MS Word is to select all text with CTRL+A and set the proofing language of your document before you start your final spelling and grammar check. If some minor portion of the text appears – as should be – in another language you can just ignore the flagged words during the verification stage. If you start with a blank document use CTRL+A before you start typing to change the language of the text to your target language.

TEXT ALIGNMENT

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

LINE SPACING

Paragraph: single-line spacing (one line before and one line after must not be used).
Between paragraphs: one additional single-line spacing.
Between headings and text: see information on headings below.

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 – (SmPC only)

1.1 Subheadings (bold, normal letters)
 (1 single line before and 1 single line after)

SUBHEADINGS – (package leaflet only)

Subheadings (no numbering, bold, normal letters)
(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
italics: Additional subheading
underline: Additional subheading
italics and underline: Additional subheading

HEADINGS NUMBERING

Must respect the current template. No additional numbering should be created. Do not use automatic numbering insertion.

BOXED HEADINGS

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.

NOTE: 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)

SHADED TEXT

Shaded text can be used by applicants to highlight text which will not be printed in the actual SmPC, PL or label. Its use should be limited.

examples of use for shaded text QRD template pharmaceutical product information

This information, presented with some errors in relation to SmPC subheadings and font colour (automatic, not black) can also be found here. Please note that EMA may decide to deactivate/update information available at certain links.
For the most recent information on QRD templates please refer to https://www.ema.europa.eu/

Names of EU-EEA countries

Download this document in Excel format for upload to your terminology management software. If you need it in another format, please contact us.