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

[N.B.: boxed headings in Annex IIIA are provided to help applicants when completing the template; they should remain in the opinion/decision. However, they are not to appear in the final printed packaging materials (mock-ups/specimens).

A separate text for outer and inner packaging labelling should be completed per strength and per pharmaceutical form. Different pack-sizes of the same strength can be presented in one document. Upon adoption by CHMP of a combined labelling text, the text does not need to be separated after adoption of the opinion.

A separate package leaflet should be provided per strength and per pharmaceutical form. During the evaluation process however, applicants may present package leaflets for different strengths in one document, clearly indicating the strength or presentation to which alternative text elements refer. Where applicants consider to also market a combined package leaflet, a detailed justification for such a combined package leaflet will have to be included after the PL text and included in the application at submission or at the latest at Day 121. The justification should take into account the QRD guidance as published in the "Compilation of QRD decisions on stylistic matters". Upon CHMP agreement (on a case-by-case basis) with a combined package leaflet text, the text does not need to be separated after adoption.

However, in all other cases, a separate package leaflet per strength and per pharmaceutical form, containing all pack-sizes related to the strength and pharmaceutical form concerned will have to be provided by the applicant as follows:

- English language version: immediately after adoption of the opinion
- All other language versions: at the latest 40 days after adoption of the opinion (i.e. at the latest after incorporation of Member States comments)


Text which will not appear in the final printed material is to be presented as shaded text]

A. LABELLING

[NOTE: these are all mandatory items listed in Title V of Directive 2001/83/EC, as amended. The data should be presented according to the template below, irrespectively of their sequence on the actual labelling and their position and possible repetition on the individual sides/flaps of the packaging (e.g. top flap, front, back etc.). Blue-boxes and their contents should not be included.

Where the same text for outer and inner packaging is used, this should be clearly indicated in {nature/type}. Text which is identical for different presentations should be provided only once e.g. text of inner vial label where such vial is part of different pack-sizes.]

[Boxed headings are provided to help applicants when completing the template; they should remain in the opinion/decision annexes. However, they are not to appear in the final printed packaging materials (mock-ups/specimens).]

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>} [as it appears in the SPC under section 1]
{Active substance(s)}

[The reference to the active substance should correspond to the strength expressed in the name.

E.g.

Name 60 mg capsules
toremifene

(since 60 mg corresponds to toremifene, even if the active substance is actually present as toremifene citrate)


Name 60 mg tablets
diltiazem hydrochloride

(since 60 mg corresponds to the hydrochloride salt)]


[For mock-ups and specimens, this information may be presented on different lines of text or in different font sizes if necessary, provided that the appearance of the name is as an integrated item.

E.g.

(invented) name Z mg/ml
Solution for injection]


2. STATEMENT OF ACTIVE SUBSTANCE(S)

[Expressed qualitatively and quantitatively per dosage unit or according to the form of administration for a given volume or weight. Where the active substance is present as a salt, this should be clearly indicated. E.g. for the examples given above: "60 mg toremifene (as citrate)" or "toremifene citrate equivalent to 60 mg toremifene"; "60 mg diltiazem hydrochloride".]

3. LIST OF EXCIPIENTS

[Express qualitatively those excipients known to have a recognised action or effect and included in guideline on "Excipients in the Label and Package Leaflet of Medicinal Products for Human Use" (The rules governing medicinal products in the European Union, Volume 3B). However, if the medicinal product is a parenteral, a topical or an eye preparation or if used for inhalation, all excipients must be stated.]

4. PHARMACEUTICAL FORM AND CONTENTS

[Pharmaceutical form according to the full terms in the current version of the "Standard terms" published by the Council of Europe if not already included in the name; Contents by weight, by volume or by number of doses or number of units of administration of the medicinal product (i.e. pack size, including a reference to any ancillary items included in the pack such as needles, swabs etc…). In case of a combined labelling text covering different pack-sizes of the same strength, each pack-size should be listed on a separate line.]

5. METHOD AND ROUTE(S) OF ADMINISTRATION

[Method of administration: directions for proper use of the medicinal product, e.g. "Do not swallow", "Do not chew", "Shake well before use". If full details cannot be included on the outer packaging itself, a reference to the package leaflet should be made, e.g. "Read the package leaflet before use".]

[Route of administration according to the current version of the "Standard terms" published by the Council of Europe]

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]

[Month: 2 digits or 3 characters; year: 4 digits. Expiry date refers to the last day of the month.]

[Where applicable, shelf life after reconstitution, dilution or after first opening the container. Please refer to CHMP "Note for Guidance on Maximum Shelf Life for Sterile Products for Human Use after First Opening or Following Reconstitution" (CPMP/QWP/159/96). If however the maximum in-use shelf life for the reconstituted product varies, depending on how, or with what, it is reconstituted, then there should be a statement on the label, such as: "read the leaflet for the shelf life of the reconstituted product".]

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

[E.g. radiopharmaceuticals, cytostatics]

11. NAME AND ADDRESS OF THE MARKETING AUTHORISATION HOLDER

[Including town, postal code (if available) and country name in the language of the text (Telephone, fax numbers, email addresses or websites are not allowed).]

12. MARKETING AUTHORISATION NUMBER(S)

[Item to be completed by the Marketing Authorisation Holder once the Marketing Authorisation has been granted.] [In case of a combined labelling text covering different pack-sizes of the same strength, the respective pack-size should be included in grey shading after the corresponding EU Sub-Number and listed on a separate line. e.g.

EU/0/00/000/001 28 tabletes
EU/0/00/000/001 56 tabletes
EU/0/00/000/001 100 tabletes

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

[Only for medicinal products not subject to medical prescription only, include:

- Indication(s)

- Dosage recommendations and contraindication(s), if full details cannot be printed a reference to the package leaflet should be made, e.g. "Read the package leaflet before use"

- General warnings and overdose warnings are not routinely required, but for certain medicinal products such warnings may be added during the procedure at the request of the CHMP.]


MINIMUM PARTICULARS TO APPEAR ON BLISTERS OR STRIPS

{NATURE/TYPE}

1. NAME OF THE MEDICINAL PRODUCT

[Pharmaceutical form short terms according to the current version of the "Standard terms" published by the Council of Europe may be used in case of space limitation, if consistently used in all language versions.]

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

[Active substance - see guidance in section 1 of the outer packaging]

2. NAME OF THE MARKETING AUTHORISATION HOLDER

{Name} [Full/short name of the Marketing Authorisation Holder]

3. EXPIRY DATE

[Month: 2 digits or 3 characters; year: 4 digits. Expiry date refers to the last day of the month.] [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

[Pharmaceutical form short terms according to the current version of the "Standard terms" published by the Council of Europe may be used in case of space limitation, if consistently used in all language versions.]

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

[Where different labels apply to different constituents of the pharmaceutical form, the pharmaceutical form in the name on the specific label should only refer to the constituent concerned (e.g. separate label for powder vial and solvent ampoule)]

2. METHOD OF ADMINISTRATION

[Method of administration: directions for proper use of the medicinal product, e.g. "Do not swallow", "Do not chew", "Shake well before use". If full details cannot be included on the immediate packaging itself, a reference to the package leaflet should be made, e.g. "Read the package leaflet before use".]

3. EXPIRY DATE

[Month: 2 digits or 3 characters; year: 4 digits]

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

[Where applicable, shelf life after reconstitution, dilution or after first opening the container. Please refer to "Note for Guidance on Maximum Shelf Life for Sterile Products for Human Use after First Opening or Following Reconstitution" (CPMP/QWP/159/96).]

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

[NOTE: the following items must appear in the package leaflet as required by Title V of Directive 2001/83/EC, as amended. Information may be presented under alternative headings. For certain medicinal products not all items may be relevant, in this case the corresponding heading should not be included. The leaflet must be readable for the patient; please refer to the "Guideline on the Readability of the Label and Package Leaflet of Medicinal Products for Human Use" as published on the Website of the European Commission in the Notice To Applicants, Volume 2C.

Throughout the text "X" stands for the (invented) name of the medicinal product.]

PACKAGE LEAFLET
[Heading to be printed]

[For medicinal products available only on prescription:]

<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.>


[For medicinal products available without a prescription:]

<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


[Name of the medicinal product]

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

[The (invented) name of the medicinal product (referred to as X throughout this document) should be stated here in bold, followed by the strength and pharmaceutical form (i.e. as it appears in the SPC). This should be followed by the active substance (as stated on the label section 1), which may be written on the line below.]

[Full statement of the active substance(s) and excipient(s)] [The active substance(s) (expressed qualitatively and quantitatively) and the other ingredients (expressed qualitatively) should be identified using their names as given in the SPC and in the language of the text: e.g.]

- The active substance is… [see guidance in section 2 of outer packaging]
- The other ingredients are... [separate the excipients of the different parts of the medicinal product, e.g. tablet core/coating, capsule contents/shell; powder/solvent (e.g. water for injections)]


[Name and address of the marketing authorisation holder and of the manufacturing authorisation holder responsible for batch release, if different]

[State the name and address of the Marketing Authorisation Holder and identify as such e.g. "Marketing Authorisation Holder: ABC Ltd, etc..." (Full address: name of the country to be stated in the language of the text, no telephone, fax numbers, email addresses or websites).]

[State the name and address of the manufacturer and identify as such e.g. "Manufacturer: DEF Ltd, etc..." (Full address: name of the country to be stated in the language of the text. Telephone or fax numbers, email addresses or websites are not allowed)].

[If MAH and manufacturer are the same, a general heading "Marketing Authorisation Holder and Manufacturer" can be used.]

[In cases where more than 1 manufacturer responsible for batch release is designated, all should be listed here. However, the printed package leaflet of the medicinal product must clearly identify the manufacturer responsible for the release of the concerned batch or mention only the specific manufacturer responsible for the release of that batch.]

1. WHAT X IS AND WHAT IT IS USED FOR

[Pharmaceutical form and contents; pharmacotherapeutic group] [The pharmaceutical form and contents and the pharmacotherapeutic group or type of activity should be stated here using patient understandable language. The pharmaceutical form should be stated according to the full "Standard Terms" published by the Council of Europe and an additional patient-friendly explanation may be given if necessary. All pack sizes for this pharmaceutical form and strength should be detailed here, if appropriate indicate that not all pack sizes may be marketed. A cross-reference to other pharmaceutical forms and strengths may be included.]

[It is recommended to include a physical description e.g. shape, colour, texture, imprint.]

[Therapeutic indications]
[The therapeutic indications should be stated here, using patient understandable language. If appropriate, specify that:]

<This medicinal product is for diagnostic use only.>

2. BEFORE YOU <TAKE> <USE> X

[List of information necessary before taking the medicinal product]

[The whole section 2 must take into account the particular condition of certain categories of users, e.g. children and the elderly (specify the age range; for children see CHMP Note for Guidance on Clinical Investigation of Medicinal Products in Children (CPMP/EWP/462/95)); special patient populations, e.g. patients with renal or hepatic impairment.]

[Absolute contraindications]

Do not <take> <use> X:

-<if you are hypersensitive (allergic) to {active substance} or any of the other ingredients of X.>
[include reference to residues, if applicable]
-<if you...>


[Give information on absolute contraindications here in accordance with the SPC; this should be in patient understandable language and should be strictly limited to contraindications, including contraindications due to interactions with other medicinal products. Other precautions and special warnings should be made in the next section.]

[Appropriate precautions for use; special warnings]

Take special care with X:

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


[Information, in patient-friendly language, on relative contraindications, special warnings and appropriate precautions for use should be provided here. Include information on interactions with other medicinal products.]

[Interactions with food and drink]

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

[Use by pregnant or breast-feeding women]

Pregnancy

[Include conclusion summary of the information given in the SPC, in addition to the following optional statement]

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

Breast-feeding

[Include conclusion summary of the information given in the SPC, in addition to the following optional statement]

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

[Effects on the ability to drive or to use machines]

Driving and using machines:

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

[Excipient warnings]

Important information about some of the ingredients of X:

[If appropriate, details of those excipients knowledge of which is important for the safe and effective use of the medicinal product and included in the guideline on "Excipients in the Label and Package Leaflet of Medicinal Products for Human Use" (The rules governing medicinal products in the European Union, Volume 3B).]

[Interaction with other medicinal products]

<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

[Instructions for proper use]

[The following 4 items can be combined as one paragraph]

[Dosage]

<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.>

[Method and/or route(s) of administration]

[Method of administration: directions for a proper use of the medicinal product; e.g. "Do not swallow", "Do not chew", "Shake well before use".

Route(s) of administration according to "Standard Terms" published by the Council of Europe and an additional patient-friendly explanation may be given if necessary.]

[Frequency of administration]
[Specify if necessary the appropriate time at which the medicinal product may or must be administered.]

[Duration of treatment]
[Specify in which cases it should be limited.]

[Symptoms in case of overdose and actions to be taken]

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

[Describe how to recognise if someone has taken an overdose and what to do.]

[Actions to be taken when one or more doses have been missed]

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

[Make clear to patients what they should do after irregular use of a product; e.g.:]

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

[Indication of the risk of withdrawal effects]

Effects when treatment with X is stopped:

[Indicate any effects of interrupting or ending the treatment early, if applicable.

Indicate withdrawal effects when the treatment ends, when necessary.]

4. POSSIBLE SIDE EFFECTS

[Description of side effects (frequency according to MedDRA)] [Begin this section with:]

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>.]

[Close this section with:]

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

5. STORING X

[Storage conditions and expiry date][For Storage condition statements see Appendix III ]

Do not use after the expiry date stated on the <label> <carton> <bottle> <...>

[Where applicable, shelf life after reconstitution, dilution or after first opening the container.

Please refer to "Note for Guidance on Maximum Shelf Life for Sterile Products for Human Use after First Opening or Following Reconstitution" (CPMP/QWP/159/96).]

[Where appropriate, warning against certain visible signs of deterioration]

<Do not use X if you notice {description of the visible signs of deterioration}.>

6. FURTHER INFORMATION

- [Listing of local representatives is not a requirement, but where used they must be stated for all Member States. However, a representative may be designated for more than one country and may also be the MAH where no other local representative is indicated. In cases where the same representative is designated for more than one country, the representative's details may be listed only once below the names of the countries concerned.

- Where a local representative is located outside the country concerned and where an address is given, the country name must be included in the address of the local representative and must be given in the language(s) of the country for which the local representative is designated.

- ISO country codes* may be used to replace the full name of the country heading. ISO codes together with the respective names of EU/EEA countries can be found at the following web site: http://publications.eu.int/code/en/en-370101.htm.

- In order to save space in the printed package leaflet, local representatives may be presented sequentially rather than in a tabulated format. In case of multi-lingual leaflets, the list of local representatives can be printed only once at the end of the printed leaflet.

- The local representative may be indicated by name, telephone number and electronic e-mail address (optional) only. Postal address may be added space permitting. Website addresses or e-mails linking to websites are not allowed.

- If a representative is outside the relevant country, indicate the name of the country.

- For Belgium (Brussels) and Finland (Swedish speaking Finland) addresses may appear in two languages, respectively Dutch/French and Finnish/Swedish.

- For Greece and Cyprus, the address must appear in Greek.


Telephone numbers: international dialling code followed by the area code and telephone number, e.g. EMEA Tel: + 44-(020) 7418 8400.]

*[except for the United Kingdom, for which UK is recommended (instead of the ISO code GB]

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 {MM/YYYY}

[Date of granting of the Marketing Authorisation/approval of latest variation or transfer, e.g. the latest Commission Decision, implementation date of the Urgent Safety Restriction or date of EMEA letter/notification; Item to be completed by the Marketing Authorisation Holder at time of printing.]

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

[Include practical information on preparation and/or handling of the medicinal product for medical and healthcare professionals only in this section, WHERE RELEVANT.

If other additional scientific information is to be included in the package for the healthcare professional, this can be achieved by either:

providing the complete SPC as a separate document in the product package
adding the complete SPC as a tear-off section at the end of the printed PL.


The intention to include the complete SPC and the way in which this will be achieved must be justified by the applicant and indicated at the end of Annex III B without actually repeating the complete latest SPC text. Applicants should carefully consider whether including such scientific information in the pack is appropriate, taking into account the nature of the product. The product information must be presented in an identical way in all EU languages.]

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