Compilation of quality review of documents (QRD) on stylistic matters in product information
29 February 2024
- 29 February 2024
EMA/25090/2002 rev.23*
Human Medicines DivisionCompilation of QRD decisions on stylistic matters in product information
Issues
AbbreviationsConnected problems
Subscript and superscriptQRD Suggestions
Acronyms must be written in their standard form; e.g. - Cmax, Cmax
Abbreviations andNot 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/25090/2002Page 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 peninformation annexes?
- Compilation of QRD decisions on stylistic matters in product information
EMA/25090/2002Page 3/23
Issues
DesiccantConnected 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/25090/2002Page 5/23
Issues
Foreign termsConnected 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/25090/2002Page 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/25090/2002Page 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/25090/2002Page 14/23
Issues
Connected problems
QRD Suggestions
considered, e.g. - Compilation of QRD decisions on stylistic matters in product information
EMA/25090/2002Page 16/23
Issues
Symbols: Non-UnicodeConnected 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/25090/2002Page 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/25090/2002Page 23/23