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29 February 2024

Key Points:

29 February 2024
EMA/25090/2002 rev.23*
Human Medicines Division
Compilation of QRD decisions on stylistic matters in product information
Issues
Abbreviations

Connected problems
Subscript and superscript

QRD Suggestions
Acronyms must be written in their standard form; e.g.
Cmax, Cmax
Abbreviations and
Not always understood,

Non-standard abbreviations and acronyms should be avoided, and the term should be written out in full.
The same applies when stating the pharmaceutical form in section 3 of the SmPC and section 4 of the labelling;
i.e.
critical steps prior to administration of the product should also be included (section 5 of Annex IIIA).
Compilation of QRD decisions on stylistic matters in product information
EMA/25090/2002
Page 2/23

Issues

Connected problems

QRD Suggestions

emphasise in the labelling
the special handling prior
to administration of the
product.
Consistency
Inconsistencies in style are

Once a particular style or house style has been selected, it must be used consistently throughout the text.
Tradename 150 mg solution for injection in pre-filled syringe
Tradename 150 mg solution for injection in pre-filled pen
information annexes?
Compilation of QRD decisions on stylistic matters in product information
EMA/25090/2002
Page 3/23

Issues
Desiccant

Connected problems

QRD Suggestions

For medicinal products

The foil of blister packs containing a desiccant must be clearly labelled to show which blister pocket contains

packaged with a desiccant

the desiccant.
For bottles containing a desiccant, a similar statement should also be considered provided there
mistake the desiccant for a

is available space.
It can only be included in brackets in section 3 of the
where can this be

SmPC and section 4 of the labelling.
Direct speech should only
be used in section 6 of the SmPC for instructions about shelf-life, storage, handling and disposal.
The term ?drug? though can be used in the product information annexes when it is part of a standard set of
terms (e.g.
Compilation of QRD decisions on stylistic matters in product information
EMA/25090/2002
Page 5/23

Issues
Foreign terms

Connected problems

QRD Suggestions

Foreign terms, particularly

Foreign terms must be written in italics; e.g.
Patients can be referred to as ?he? or
physician is often referred

as ?she? when the medicinal product is exclusively for use by males or females.
if the product in question might be
measurements are

used by elderly patients), in brackets after the metric measures in the English text.
Compilation of QRD decisions on stylistic matters in product information
EMA/25090/2002
Page 6/23

Issues

Connected problems

QRD Suggestions

product name is composed
of MAH+INN?
Compilation of QRD decisions on stylistic matters in product information
EMA/25090/2002
Page 7/23

Issues

Connected problems

QRD Suggestions
MT: English
BG: Bulgarian
NL: Dutch
CZ: Czech or English at applicant?s discretion.
Compilation of QRD decisions on stylistic matters in product information
EMA/25090/2002
Page 14/23

Issues

Connected problems

QRD Suggestions
considered, e.g.
Compilation of QRD decisions on stylistic matters in product information
EMA/25090/2002
Page 16/23

Issues
Symbols: Non-Unicode

Connected problems

QRD Suggestions

The use of non-Unicode

Only Unicode symbols must be used in submitted product information annexes.
Compilation of QRD decisions on stylistic matters in product information
EMA/25090/2002
Page 20/23

Issues

Connected problems

Units: SI base units -

International Standard

litre

base units have been
introduced in the European
Union with Council
Directive 80/181/EEC of
20.12.79 (O.J.
Compilation of QRD decisions on stylistic matters in product information
EMA/25090/2002
Page 23/23