WHOPAR Guidance for Applicants
(2004; 140 pages)
Table of Contents
View the documentGuidance note to Applicants (Manufacturers) on the compilation of the WHO Public Assessment Report version 1.0 - December 2004
View the documentAppendix 1 - Characteristics of WHOPAR Parts
View the documentAppendix 2 - Documentation to submit together with the initial submission
Close this folderAppendix 3 - Guidance on Package Leaflet, Summary of Product Characteristics and Labelling
View the documentANNEX I - Summary of product characteristics - Word Templates
View the documentANNEX III - Labelling and package leaflet - Word Templates
View the documentANNEX I - Summary of product characteristics - annotated
View the documentANNEX III - Labelling and package leaflet
View the documentAPPENDIX I - Statements for use in Section 4.6 "Pregnancy and lactation" of SPC
View the documentAPPENDIX II - MedDRA terminology to be used in Section 4.8 "Undesirable effects" of SPC
View the documentAPPENDIX III - Standards for required storage standards
View the documentAPPENDIX IV - Terms for batch number & expiry date to be used on outer and/or inner labelling
View the documentConvention to be followed for EMEA-QRD templates
View the documentCompilation of QRD decisions on the use of terms
View the documentCompilation of QRD decisions on stylistic matters in product information
View the documentTables of non-standard abbreviations
View the documentAppendix 4 - Format of the Summary of Product Safety and Efficacy
 

Compilation of QRD decisions on the use of terms

Term

approved

preferred

acceptable in PL

not to be used

Comments

Go to

acetylsalicylic acid

X

     

According to the case, refer to ASA in package leaflets (e.g. for interactions) as follows: "acetylsalicylic acid <a substance present in many medicines used to relieve pain and lower fever> or <a substance present in many medicines used to prevent blood clotting>". Alternatively, as appropriate, use: " acetylsalicylic acid, a substance present in many medicines used to relieve pain and lower fever, as well as to prevent blood clotting "

For the translations of the ASA statements in the EU official languages, plus Icelandic and Norwegian, please click

active ingredient

     

X

 

active substance

active substance

X

         

adolescents

X

     

age 12 years to 17 years (Note for guidance on clinical investigation of medicinal products in children,

 

adverse effects

     

X

 

undesirable effects, adverse events, adverse reactions

adverse reactions

X

     

is to be used where there is a causal relationship with the use the medicinal product

undesirable effects, adverse events, adverse reactions

adverse events

X

     

is to be used where it occurs during the use of the medicinal product but its causal relationship is not yet established. Note that adverse events without at least a suspected causal relationship should not be listed in the SPC.

undesirable effects, adverse events, adverse reactions

aspirin

     

X

 

acetylsalicylic acid

breast-feeding

 

X

       

children

X

     

age 2 years to 11 years (Note for guidance on clinical investigation of medicinal products in children,

 

children, young

     

X

see Note for guidance on clinical investigation of medicinal products in children, CPMP/EWP/462/97.

children, infants and toddlers (depending on age)

clinical studies

X

     

correct term, if chosen must be used consistently throughout text without alternating with "clinical trials".

 

clinical trials

X

     

correct term, if chosen must be used consistently throughout text without alternating with "clinical studies".

 

dextrose

     

X

Not in Ph. Eur.

glucose

dosage

X

     

to be used in package leaflets instead of "posology".

posology

drug

     

X

 

active substance; medicinal product

drug substance

     

X

 

active substance; medicinal product

excipients

X

     

to be used in SPC. In PL: "other ingredients" is accepted.

other ingredients

expiration

     

X

 

expiry, expiry date

expiry

X

         

expiry date

X

         

formulation

     

X

 

medicinal product

glucose

X

     

Ph. Eur.

 

health experts

     

X

Reference to "health experts" generally means "best medical practice". It is advised to use the wording "It is recommended

 

HIV

     

X

 

HIV negative

HIV associated

X

     

should not be hyphenised, as a hyphen at the end of a line can be mistaken for a negative sign.

 

HIV infected

X

       

HIV positive

HIV negative

X

         

HIV positive

X

         

HIV+

     

X

 

HIV infected/HIV positive

HIV-infected

     

X

the hyphen at the end of a line can be mistaken for a negative

HIV infected

inactive ingredient

     

X

 

"excipients" in SPC, "other ingredients" in PL

inactive substance

     

X

 

"excipients" in SPC, "other ingredients" in PL

infants and toddlers

X

     

age 28 days to 23 months (Note for guidance on clinical investigation of medicinal products in children,

 

intramuscular route

     

X

 

intramuscular use

intramuscular use

X

     

"Standard Terms" published by the Council of Europe.

 

intravenous

X

         

intravenous route

     

X

 

intravenous use

intravenous use

X

     

"Standard Terms" published by the Council of Europe.

 

lactating mothers

     

X

 

nursing mothers

medication

     

X

 

medicinal product

medicinal product

X

         

medicine

   

X

   

medicinal product

nursing mothers

   

X

     

other ingredients

   

X

 

to be used in package leaflet. In SPC use "excipients".

excipients

overdose

X

         

overdosage

     

X

 

overdose

pack size

X

         

posology

X

     

to be used in SPC. In package use "dosage".

 

presentation

     

X

ambiguous can mean "pack size" or "pharmaceutical form"

pack size

pre-term new-born infants

X

     

<36 weeks of gestation (Note for guidance on clinical investigation of medicinal products in children,

 

rash

 

X

   

Is sometimes left in EN in translations. Preferred terms in all languages must be established.

 

Radio-active medicinal product

     

X

 

Radiopharmaceuticals

Radiopharmaceuticals

 

X

       

saline

     

X

 

sodium chloride solution

side effects

   

X

 

for use in PL or labelling only.

undesirable effects, adverse reactions

sodium chloride solution

X

     

specify concentration, e.g. "sodium chloride 9 mg/ml (0.9%) solution for injection"

 

subcutaneous use

X

     

"Standard Terms" published by the Council of Europe.

 

new-born infants

X

     

age 0-27 days (Note for guidance on clinical investigation of medicinal products in children, CPMP/EWP/462/97)

 

Keys

approved

preferred

acceptable in PL

not to be used

Definitions

Approved

X

     

Terms used in legislation and templates, or originating from other official sources

Preferred

 

X

   

Terms which cannot be traced to a specific source, but which the group understands to constitute "good practice" and prefers to any other of the same meaning

Acceptable in PL

   

X

 

Terms considered to be correctly used in Package Leaflet (which requires "patient-friendly" terms). Such terms are accompanied by a "Go to" reference to the approved term

Not to be used

     

X

Terms which the group deems unsuitable for use because misleading, unclear, obsolete or for other reasons. The "Go to" reference always leads to the approved term.

PIQ/QRD Secretariat

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

 

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