Compilation of quality review of documents (QRD) on stylistic matters in product information

29 February 2024

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Provider: 
European Medicines AgencyEuropean Medicines Agency
URL: 
https://www.ema.europa.eu/en/documents/regulatory-procedural-guideline/compilation-quality-review-documents-qrd-stylistic-matters-product-information_en.pdfhttps://www.ema.europa.eu/en/documents/regulatory-procedural-guideline/compilation-quality-review-documents-qrd-stylistic-matters-product-information_en.pdf
Retrieved on: 
Sunday, March 10, 2024
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Capsule, HPRA, EXP, NAAM, Pi, CS, ATMP, Table, Unicode, Health education, Potassium iodide, Syringe, VIAL, Inn, Potassium, NRG, Powder, Translation, Blister, Patient, Guideline, Abbreviation, SIDC, WHO, COPD, ISO, Compilation, Diabetes, DA, Prohibition, Times New Roman, Excipient, Narcotic, FAQ, Approximation error, Sodium chloride, PI, Cmax, Microsoft Word, NOT, Veterinary medicine, European Medicines Agency, Council, PFU, QRD, Helicobacter pylori, Tablet, Microsoft, Total, Medication package insert, European, DIE, Language, Single Supervisory Mechanism, Plaque, Vaccine, MAH, Safety, Printing, International standard, Sodium, Osteoporosis, Reproduction, Name, Marketing authorisation, Marketing, Caregiver, Imperial, NCA, Food, EDQM, Confusion, Risk, Cell, Medicine, Disease, Public, Medical device
Geotags: 
SV, EUROPEAN UNION, DE, HU, ES, NO, SK, EE, FI, LT, EC, NL, SL, CZ, BE, DK, ET, CY, PL, LOT, PH, RO, FR, SI, PT, NETHERLANDS, BG, FRANCE, EU, MT, BELGIUM, LV, SLOVAKIA
Summary
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

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