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
 

ANNEX III - Labelling and package leaflet - Word Templates

A. LABELLING

PARTICULARS TO APPEAR ON THE OUTER PACKAGING OR, WHERE THERE IS NO OUTER PACKAGING, ON THE IMMEDIATE PACKAGING

{NATURE/TYPE}

1. NAME OF THE MEDICINAL PRODUCT

{(Invented) name <strength> <pharmaceutical form>}
{Active substance}

2. STATEMENT OF ACTIVE SUBSTANCE(S)

3. LIST OF EXCIPIENTS

4. PHARMACEUTICAL FORM AND CONTENTS

5. METHOD AND ROUTE(S) OF ADMINISTRATION

6. SPECIAL WARNING THAT THE MEDICINAL PRODUCT MUST BE STORED OUT OF THE REACH AND SIGHT OF CHILDREN

Keep out of the reach and sight of children.

7. OTHER SPECIAL WARNING(S), IF NECESSARY

8. EXPIRY DATE

[For terms on Batch number and Expiry date see Appendix IV]

9. SPECIAL STORAGE CONDITIONS

[For Storage condition statements see Appendix III]

10. SPECIAL PRECAUTIONS FOR DISPOSAL OF UNUSED MEDICINAL PRODUCTS OR WASTE MATERIALS DERIVED FROM SUCH MEDICINAL PRODUCTS, IF APPROPRIATE

11. NAME AND ADDRESS OF THE MARKETING AUTHORISATION HOLDER

12. MARKETING AUTHORISATION NUMBER(S)

EU/0/00/000/000

13. MANUFACTURER'S BATCH NUMBER

[For terms on Batch number and Expiry date see Appendix IV]

14. GENERAL CLASSIFICATION FOR SUPPLY

<Medicinal product subject to medical prescription.>
<Medicinal product not subject to medical prescription.>

15. INSTRUCTIONS ON USE

MINIMUM PARTICULARS TO APPEAR ON BLISTERS OR STRIPS

1. NAME OF THE MEDICINAL PRODUCT

{(Invented) name, strength and pharmaceutical form}
{Active substance}

2. NAME OF THE MARKETING AUTHORISATION HOLDER

{Name}

3. EXPIRY DATE

[For terms on Batch number and Expiry date see Appendix IV]

4. BATCH NUMBER

[For terms on Batch number and Expiry date see Appendix IV]

MINIMUM PARTICULARS TO APPEAR ON SMALL IMMEDIATE PACKAGING UNITS {NATURE/TYPE}

1. NAME OF THE MEDICINAL PRODUCT AND ROUTE(S) OF ADMINISTRATION

{(Invented) name, strength and pharmaceutical form}
{Route of administration}

2. METHOD OF ADMINISTRATION

3. EXPIRY DATE

[For terms on Batch number and Expiry date see Appendix IV]

4. BATCH NUMBER

[For terms on Batch number and Expiry date see Appendix IV]

5. CONTENTS BY WEIGHT, BY VOLUME OR BY UNIT

B. PACKAGE LEAFLET

PACKAGE LEAFLET

<Read all of this leaflet carefully before you start <taking> <using> this medicine.

- Keep this leaflet. You may need to read it again.
- If you have further questions, please ask your doctor or your pharmacist.
- This medicine has been prescribed for you personally and you should not pass it on to others. It may harm them, even if their symptoms are the same as yours.>


<Read all of this leaflet carefully because it contains important information for you.

This medicine is available without prescription. Nevertheless you still need to use X carefully to get the best results from it.

- Keep this leaflet. You may need to read it again.
- Ask your pharmacist if you need more information or advice.
- You must see a doctor if your symptoms worsen or do not improve <after {number of} days.>


In this leaflet:

1. What X is and what it is used for
2. Before you <take> <use> X
3. How to <take> <use> X
4. Possible side effects
5 Storing X
6. Further information

{(Invented) name strength and pharmaceutical form}
{Active substance}

- The active substance is…
- The other ingredients are...


{Marketing Authorisation Holder}
<{Manufacturer}>

1. WHAT X IS AND WHAT IT IS USED FOR

<This medicinal product is for diagnostic use only.>

2. BEFORE YOU <TAKE> <USE> X

Do not <take> <use> X:

- <if you are hypersensitive (allergic) to {active substance} or any of the other ingredients of X.>
- <if you...>


Take special care with X:

- <if you...>
- <when...>


<Taking> <Using> X with food and drink:

Pregnancy

<Ask your doctor or pharmacist for advice before taking any medicine.>


Breast-feeding

<Ask your doctor or pharmacist for advice before taking any medicine.>


Driving and using machines:

<Do not <drive because...>
<Do not operate any tools or machines.>


Important information about some of the ingredients of X:

<Taking> <Using> other medicines:

<Please inform your doctor or pharmacist if you are taking or have recently taken any other medicines, even those not prescribed.>

3. HOW TO <TAKE> <USE> X

<Always <take> <use> X exactly as your doctor has instructed you. You should check with your doctor or pharmacist if you are unsure.> <The usual dose is...>

<If you have the impression that the effect of X is too strong or too weak, talk to your doctor or pharmacist.>

If you <take> <use> more X than you should:

If you forget to <take> <use> X:

<Do not take a double dose to make up for forgotten individual doses.>

Effects when treatment with X is stopped:

4. POSSIBLE SIDE EFFECTS

Like all medicines, X can have side effects.

[Describe, if necessary, the actions to be taken. If the patient needs to seek help urgently use the term <immediately>; for less urgent conditions use the phrase <as soon as possible>.]

If you notice any side effects not mentioned in this leaflet, please inform your doctor or pharmacist.

5. STORING X

[For Storage condition statements see Appendix III]

6. FURTHER INFORMATION

For any information about this medicinal product, please contact the local representative of the Marketing Authorisation Holder.

België/Belgique/Belgien
{Nom/Naam/Name}
<{Adresse/Adres/Anschrift }
B-0000 {Localité/Stad/Stadt}>
Tél/Tel: + {N° de téléphone/Telefoonnummer/ Telefonnummer}
<{e-mail}>

Luxembourg/Luxemburg
{Nom}
<{Adresse}
L-0000 {Localité/Stadt}>
Tél/Tel: + {N° de téléphone/Telefonnummer}
<{e-mail}>

Česká republika
{Název}
<{Adresa}
CZ {město}>
Tel: +{telefonní íslo}
<{e-mail}>

Magyarország
{Név}
<{Cím}
H-0000 {Város}>
Tel.:{Telefonszám}
<{e-mail}>

Danmark
{Navn}
<{Adresse}
DK-0000 {by}>
Tlf: + {Telefonnummer}
<{e-mail}>

Malta
{Isem}
<{Indirizz}
MT-0000 {Belt/Rahal}>
Tel: + {Numru tat-telefon}
<{e-mail}>

Deutschland
{Name}
<{Anschrift}
D-00000 {Stadt}>
Tel: + {Telefonnummer}
<{e-mail}>

Nederland
{Naam}
<{Adres}
NL-0000 XX {stad}>
Tel: + {Telefoonnummer}
<{e-mail}>

Eesti
(Nimi)
<(Aadress)
EE - (Postiindeks) (Linn)>
Tel: +(Telefoninumber)
<{e-mail}>

Norge
{Navn}
<{Adresse}
N-0000 {poststed}>
Tlf: + {Telefonnummer}
<{e-mail}>

Ελλάδα
{Όνοµα}
<{Διεύθυνση}
GR-000 00 {πόλη}>
Τηλ: + {Αριθµός τηλεφώνου}
<{e-mail}>

Österreich
{Name}
<{Anschrift}
A-00000 {Stadt}>
Tel: + {Telefonnummer}
<{e-mail}>

España
{Nombre}
<{Dirección}
E-00000 {Ciudad}>
Tel: + {Teléfono}
<{e-mail}>

Polska
{Nazwa/Nazwisko:}
<{Adres:}
PL - 00 000{Miasto:}>
Tel.: + {Numer telefonu:}
<{e-mail}>

France
{Nom}
<{Adresse}
F-00000 {Localité}>
Tél: + {Numéro de téléphone}
<{e-mail}>

Portugal
{Nome}
{Morada}
P-0000-000 {Cidade}
Tel: + {Número de telefone}
{e-mail}

Ireland
{Name}
<{Address}
IRL - {Town} {Code for Dublin}>
Tel: + {Telephone number}
<{e-mail}>

Slovenija
{Ime}
<{Naslov}
SI-0000 {Mesto}>
Tel: + {telefonska številka}
<{e-mail}>

Ísland
{Nafn}
<{Heimilisfang}
IS-000 {Borg/Bær}>
Tel: + {Símanúmer}
<{e-mail}>

Slovenská republika
{Meno}
<{Adresa}
SK-000 00 {Mesto}>
Tel: + {Telefónne číslo}
<{e-mail}>

Italia
{Nome}
<{Indirizzo}
I-00000 {Località}>
Tel: + {Numero di telefono}>
<{e-mail}>

Suomi/Finland
{Nimi/Namn}
<{Osoite/Adress}
FIN-00000
{Postitoimipaikka/Stad}>
Puh/Tel: + {Puhelinnumero/Telefonnummer}
<{e-mail}>

Κύπρος
{Όνοµα}
<{Διεύθυνση}
CY-000 00 {πόλη}>
Τηλ: + {Αριθµός τηλεφώνου}
<{e-mail}>

Sverige
{Namn}
<{Adress}
S-000 00 {Stad}>
Tel: + {Telefonnummer}
<{e-mail}>

Latvija
{Nosaukums}
<{Adrese}
{Pilsēta}, LV{Pasta indekss }>
Tel: + {Telefona numurs}
<{e-mail}>

United Kingdom
{Name}
<{Address}
{Town}
{Postal code} - UK>
Tel: + {Telephone number}
<{e-mail}>

Lietuva
{pavadinimas}
<{adresas}
LT {pašto indeksas} {miestas}>
Tel. +370{telefono numeris}
<{e-mail}>

 

This leaflet was last approved on {date}

The following information is intended for medical or healthcare professionals only:>

[Version 6.1, 07/2004]

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