WHOPAR Guidance for Applicants
(2004; 140 pages)
Índice de contenido
Ver el documentoGuidance note to Applicants (Manufacturers) on the compilation of the WHO Public Assessment Report version 1.0 - December 2004
Ver el documentoAppendix 1 - Characteristics of WHOPAR Parts
Ver el documentoAppendix 2 - Documentation to submit together with the initial submission
Cerrar esta carpetaAppendix 3 - Guidance on Package Leaflet, Summary of Product Characteristics and Labelling
Ver el documentoANNEX I - Summary of product characteristics - Word Templates
Ver el documentoANNEX III - Labelling and package leaflet - Word Templates
Ver el documentoANNEX I - Summary of product characteristics - annotated
Ver el documentoANNEX III - Labelling and package leaflet
Ver el documentoAPPENDIX I - Statements for use in Section 4.6 "Pregnancy and lactation" of SPC
Ver el documentoAPPENDIX II - MedDRA terminology to be used in Section 4.8 "Undesirable effects" of SPC
Ver el documentoAPPENDIX III - Standards for required storage standards
Ver el documentoAPPENDIX IV - Terms for batch number & expiry date to be used on outer and/or inner labelling
Ver el documentoConvention to be followed for EMEA-QRD templates
Ver el documentoCompilation of QRD decisions on the use of terms
Ver el documentoCompilation of QRD decisions on stylistic matters in product information
Ver el documentoTables of non-standard abbreviations
Ver el documentoAppendix 4 - Format of the Summary of Product Safety and Efficacy
 

Compilation of QRD decisions on stylistic matters in product information

European Medicines

Version 8.0 - November 2004

Issues

Connected problems

QRD Suggestions

Abbreviations and acronyms

Not always understood, particularly in package leaflet. Different languages have different approaches, so the acronyms are in the language of the translation or are derived from the English; e.g. ECT, COPD

Non-standard abbreviations and acronyms should be avoided and the term written out in full. In cases where this is not possible the acronym should be at least written out and introduced in brackets at its first occurrence. See also most frequently used non-standard abbreviations published on this Website.

Abbreviations

Subscript and Superscript are sometimes not used correctly in acronyms; e.g. Cmax, Cmax

Acronyms must be written in their standard form; e.g. Cmax

Antiretrovirals: reference and translations

Different practices between Member States on whether it is acceptable to have the English full term followed by the English abbreviation (e.g. protease inhibitors (PIs) etc..) or whether the full term and/or the abbreviation should be translated

EL, FR, HU, LT, IS, SL: full term and the abbreviation in national language CS, DE, ES, ET, FI, IT, LV, MT, NL, NO, PL, PT, SK, SE: full term in national language. English abbreviation is acceptable

Conditional

The translation of "should" causes problems in Romance languages where its literal translations actually mean "it would be preferable" or "it is recommended".

Romance languages should make use of the form that best conveys the meaning equivalent to "must" where instructions to the patient or to the doctor are given.
However, in order to offer a more precise indication on the mandatory nature of the advice it is advisable that the word "should" is avoided wherever possible in the English original itself.
E.g. "Pregnant women should not breast-feed" could be phrased as "Pregnant women must not breast-feed" "X should be taken with food" could be phrased as
"X is to be taken with food".

Consistency

Inconsistencies of style are often found in product information; e.g. punctuation, symbols, spacing, redaction style etc.

Once a particular style or house style has been selected it must be used consistently throughout the text.

Food and drink

Applicants sometimes choose examples of food to be taken with a medicinal product without considering whether such food is available in all Member-States (e.g.: apple sauce, cranberry juice).

For general food the applicant should choose examples of food to take with a medicine based on their availability and cultural acceptability in all MS.
Special meals should be described in a generic way. In the PL, if necessary, the following wording may be added: "Your doctor or pharmacist will advise you on what meal to take."

Foreign terms

Foreign and particularly Latin terms appear frequently in product literature

Foreign terms must be written in Italics; e.g. in vivo, in vitro, Helicobacter pylori.
In Greek documents foreign terms appear in their original spelling, i.e. Roman characters.

Gender

The patient or the physician is often referred to as "he".

"He/she" should be used if no other neutral gender locution is possible. Patients can be referred to as "he" or as "she" when the medicinal product is exclusively for use by males or females.

Version 8.0 - November 2004 1/5

©EMEA 2004 Reproduction and/or distribution of this doc. is authorised for non commercial purposes only provided the EMEA is acknowledged

Issues

Connected problems

QRD Suggestions

Health information

Can general information on health or disease be included in the package leaflet in certain justified cases?

Council Directive 92/27/EEC art. 7.3 states that "the package leaflet may include..." "...other information compatible with the SPC which is useful for health education, to the exclusion of any element of a promotional nature."
Information on the disease should normally be limited to a patient-friendly description of the sections "indications" and "pharmacotherapeutic group" of the SPC, under their respective headings.
Any additional concise information on the disease (e.g. symptoms and signs of the disease, general precautions and appropriate treatment or other measures to take) should only be included at the end of the package leaflet, for health education purposes. This information would usually relate to complex or chronic illnesses (e.g. diabetes, osteoporosis). Its inclusion has to be justified by the applicant, and will be assessed on a case-by-case basis.
If references to patient organisations are included in the package leaflet, such organisations must be mentioned for all EU Member States (equal access to information for patients).

Imperial measures

Surfaces or other measurements are sometimes expressed in imperial measures in the PL. Example: one sachet contains enough cream to cover an area of 20 cm2 (approx. 3 square inches).

Imperial measures, e.g. inches, can be included, where appropriate (e.g. if the product in question might be used by elderly patients), in brackets after the metric measures in the English text. These imperial measures must not appear in the translations in other languages.

Package leaflet: combined printed package leaflets.

Are combined printed package leaflets acceptable?
Are there any safety issues: i.e. are they clear for the patient?

Combined printed PLs can only be acceptable if all the following 3 conditions are met:
• posology in the SPC/PL foresees 2 dosages (e.g. a high induction dose followed by lower maintenance dose);
• PLs are completely identical, except for the few strength-specific details;
• a combined PL does not cause confusion for the patient or user The applicant must submit their request for a combined PL in advance, together with a justification/rationale. A decision will be taken on a case-by-case basis.

Number separators

Different languages use different number separators (a coma or a dot) to distinguish between thousands and decimals. Style of number must correspond to language used.

For decimals:
EN: dot, e.g. 12.50 ml
All other languages: coma, e.g. 12,50 ml
For thousand:
EN: 1,000.00 DA, DE, EL, ES, FR, IT, NL, PT, SL: 1.000,00
CS, FI, LV, PL, SK, SV: 1•000,00 or 1000,00
ET, HU: 1000,00
LT: 1 000,00
(•= non-breaking space)

Issues

Connected problems

QRD Suggestions

Trade name

Excessive use of trade name and unnecessary repetition in SPC and package leaflet/insert.

Avoid unnecessary repetition in all product information (SPC, label and package leaflet/insert). INN or pronouns should be used whenever possible in the SPC. In the package leaflet/insert the trade name or a pronoun should be used.

Trade name

Format of the trade name and use throughout text.
Is it admissible to register names with capital letters included within the trade name?
If the registered trade name is written in uppercase, must it be written as such throughout the text of the product information and in the EPAR?
What style can be used (maximum font size, bold, underlined, colour etc.)?

The trade name of a medicinal product must appear in the format it is registered, e.g. in capitals. However, in the product information, it should be written in the same font and font size as surrounding text (i.e. Times New Roman, size 11) and must not be highlighted in any way.
In such cases the applicant must provide proof of the style in which the trade name is registered.

Trade marks/ brand names of materials/devices/special meals

Use of trademarks and brand names of medicinal products, materials or devices in product information.

The common name or a generic description of the material, device or special meal should be used. When it is important for the correct use that only one specific device etc. (with a specific trademark) is used, then that specific trademark should be mentioned, together with a patient friendly general description in the PL, if necessary.

Strength: sodium chloride solution

"0.9% w/v sodium chloride solution", "9 mg/ml sodium chloride solution" or "sodium chloride 9 mg/ml (0.9%) solution".
Practices differ in the Member States.

Reference in SPC, package leaflets: "sodium chloride 9 mg/ml (0.9%) solution for injection"
Label for the vial of solvent: "sodium chloride 9 mg/ml <solution for> injection"

Strength: expression of strength in the name of medicinal product in the form of powders for reconstitution prior to parenteral administration

Can the strength in the name of medicinal product in the form of powders for reconstitution be expressed as the total quantity or as the concentration of the active substance

- For single-dose presentations, either with or without solvent, the strength should be expressed as total quantity of the active substance.

- For multi-dose presentations, the expression of strength should continue to be decided on a case by case basis until the QRD groups adopts a general rule.

Units: general format

• Space between figure and unit is missing; e.g. 100ml
• Spaces occurring within numbers or between figures and mathematical symbols might break and lead to confusion.

Preferred style is figure and unit or symbols separated by a non-breaking space; e.g.
100 ml; >•10; etc.
(•= non-breaking space)

Units: degrees

Degrees are expressed in different styles;
e.g. 10°C, 10 °C, 10° C

No space between the º symbol and the indicator of scale used; e.g.
10°C, 10°C
(•= non-breaking space)

Units: SI base units

International Standard base units have been introduced in the European Union with Council Directive 80/181/EEC of 20.12.79. (O.J. L 39 of 15.2.80). However this directive allows litre to be written either "l" or "L".

"Litre" must always be written as "l", i.e. l, ml, dl, etc.

Issues

Connected problems

QRD Suggestions

Units: microgram (µg)

Microgram in name of the medicinal product and in text
To be spelt out as "micrograms" in name of the product and in the text of package leaflet? Can it appear as µg in the text of the SPC?
However in blisters or small immediate packs there might not be enough space for the full name.

Issue addressed in the European Commission's Readability Guideline concerning the labelling and PL:
"3.3... micrograms should always be spelled out in full rather than abbreviated, for safety reasons. However, in certain instances where this poses a practical problem which cannot be solved by using a smaller point size (< 7 points Didot) then abbreviated forms may be used, if they are justified and there are no safety concerns".
In the SPC, it is acceptable to use the abbreviated form ("µg") throughout the text of the document. Except for the name of the medicinal product in section 1 of the SPC, where it should be spelled out in full to ensure consistency with the name on the label and the package leaflet.
The accepted abbreviation is "µg", although there may be some Member-States where this abbreviation is not used.

Issues

Connected problems

QRD Suggestions

"Unit dose" pack sizes

The term "unit dose" is intended to differentiate a perforated blister, which is presented to facilitate single tablet administration, from the standard tablet blister presentation.

On the outer carton, the pack size must be stated in section 4 as e.g. "28 x 1 tablets". In the SPC and Package leaflet the pack size must be stated as e.g. "28 x 1 tablets in <material*> perforated unit dose blisters". Please find below the term "perforated unit dose blisters" translated in all official languages plus Icelandic and Norwegian.
CS: perforovaný blistr jednodávkový
DA: perforeret enkeltdosisblister
DE: perforiertes Blister zur Abgabe von Einzeldosen
EN: perforated unit dose blisters
ES: blister precortado unidosis
ET: üheannuseline perforeeritud blisterpakend
FI: yksittäispakattu läpipainopakkaus
FR: plaquette thermoformée pour délivrance à l'unité
EL: διάτρητο blister, µονάδων δόσης
HU: adagonként perforált bliszter
IT: blister divisibile per dose unitaria
IS: rifgataðar stakskammtaþynnur
LT: perforuoti vienadoziai blisteriai
LV: perforeti blisteri ar vienu devu konturligzda
NL: geperforeerde eenheidsblisterverpakking
NO: perforert endoseblister
PL: blister perforowany podzielny na dawki pojedyncze
PT: blisters destacáveis para dose unitária
SK: blister s perforáciou, umoòujúci oddelenie jednotlivej dávky
SL: perforiranem pretisnem omotu za enkratni odmerek
SV: perforerad endosblister
*e.g. "Aluminium/PVC"

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