MEDICINES EVALUATION BOARD
Policy document:
Package leaflet of pharmaceutical products
MEB 5
31 August 2015
CONTENTS
1. INTRODUCTION .............................................................................................................................. 3
1.1 Other documents relevant to the package leaflet ............................................................................. 3
2. LEGAL FRAMEWORK ..................................................................................................................... 5
3. READABILITY .................................................................................................................................. 5
3.1 General.............................................................................................................................................. 5
3.2 Readability test .................................................................................................................................. 6
3.3 Technical readability ......................................................................................................................... 6
4. SPECIFIC POINTS ........................................................................................................................... 6
4.1 Information for the healthcare professionals ..................................................................................... 6
4.2 Patented indications .......................................................................................................................... 7
4.3 Marketing authorisations without Dutch translations of the product information or mock-ups ......... 7
4.4. Logos and pictograms ...................................................................................................................... 7
4.4.1 Preparation for Administration (Voor Toediening Gereed Maken [VTGM]) of medicinal products
for intravenous (IV) and subcutaneous (SC) administration in the home situation ......................... 8
4.4.2 QR-code ......................................................................................................................................... 8
4.5 Parallel import and Duplex registrations ........................................................................................... 8
4.5.1 Parallel import ................................................................................................................................ 8
4.5.2 Duplex registrations ....................................................................................................................... 9
4.6 Blue Box Information for the package leaflet .................................................................................... 9
4.7 Childproof / senior-citizen friendly packaging ................................................................................... 9
4.8 Doping warning Statement ................................................................................................................ 9
4.9 EAV/EAG packaging ......................................................................................................................... 9
4.10 Impossible or difficult dosages ...................................................................................................... 10
4.11 Package leaflet for the blind and visually impaired ....................................................................... 10
4.12 Package leaflet for children ........................................................................................................... 10
APPENDIX 1: INFORMATION ON SECTIONS OF PACKAGE LEAFLET IN THE QRD TEMPLATE 12
APPENDIX 2: QR CODE ...................................................................................................................... 20
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1. Introduction
The European legislation concerning the package leaflet is discussed in Directive 2001/83/EC.
Implementation took place in the Dutch Medicines Act and the Medicines Act Regulation. Chapter 7 of
the Medicines Act and chapter 4.a of the Medicines Act Regulation deal with the labelling and the
package leaflet.
This policy document (MEB-05) clarifies the policy on the package leaflet of pharmaceutical products
in the Netherlands. This policy is based on the aforementioned European and Dutch legislation.
The practical implementation of this legislation has been given shape in Europe in the QRD template.
An English template which includes comments and a further explanation is available. Information that
can be found in the template will not be repeated in this policy document. There is also a Dutch
translation of the sections and standard sentences.
The Board tests the compulsory textual information as well as the general readability of the package
leaflet. See chapter 3 “Readability”.
1.1 Other documents relevant to the package leaflet
Via European Committee (Eudralex):
 DIRECTIVE 2001/83/EC
 Guideline on the readability of the label and package leaflet (see volume 2c)
 Guideline on the packaging information of medicinal products for human use authorised by
the Union (see volume 2c)
 Guidance concerning the Braille requirements for labelling and the package leaflet Article 56a
of Directive 2001/83/EC as amended
 Blue box information
for products authorised through the Central Procedure, see Notice to Applicants volume 2c
Guideline on the packaging information of medicinal products for human use authorised by
the Community.
Via EMA:
 Quality review of documents (QRD) (see Product Information -> Product Information
templates)
 Guideline on the excipients in the label and the package leaflet of medicinal products for
human use
 Guideline on declaration of herbal substances and herbal preparations in herbal medicinal
products /traditional herbal medicinal products
Via CMD
 Quality review of documents (QRD) (see CMDh website Templates -> QRD)
 Q&As on CMD website (see Questions & Answers – for example, Product Information /
Information on medicinal products)
 QRD guidance and checklist for the review of user testing results (see appendix to D70
Overview Template and to MRP Overview Template)
 Consultation with target patients groups: meeting the requirements of article 59(3) without the
need for a full test – Recommendations for bridging (see Procedural Guidance - Consultation
with target patients groups)
 Position paper on user testing of package leaflets (various methods of user tests. See
Procedural Guidance - Consultation with target patients groups)
 Blue box requirements for products registered through MRP/DCP, see CMDh website ‘Bluebox’ requirements
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

Article 61(3) procedure (see Procedural Guidance - Article 61(3) procedure)
CMDh Position paper on the use of QR codes to provide information about the medicinal
product (see CMDh website)
Via MEB
 MEB-08 Guideline on the excipients in the label and the package leaflet of medicinal products
for human use (Dutch translation)
 MEB-13 Nomenclature of pharmaceutical products
 List of patient-friendly terms
 Writing tips for the medicine package leaflet
 Advice about readability tests for medicine package leaflets
 MEB website: Generic medicinal product marketing authorisation application >
Generic medicinal products and usage patents
 Form “Technical declaration of readability”
 Policy document “Board policy concerning marketing authorisations without Dutch translations
of the product information and/or mock-ups”
Via Wetten.Overheid.nl
 Dutch Medicines Act (Gnw)
 Medicines Act Regulation (RGnw)
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2. Legal framework
A package leaflet is inserted in a medicinal product's packaging (section 69, subsection 2 of the
Medicines Act)
When applying for a marketing authorisation, a package leaflet must be submitted (section 3.7
Medicines Act Regulation and article 8(3)(j) of Directive 2001/83/EC).
Changes to the package leaflet proposed by the marketing authorisation holder must be submitted to
the Medicines Evaluation Board (section 50, subsection 2 of the Medicines Act).
If it becomes apparent after granting a marketing authorisation that the package leaflet does not meet
the requirements set out in, by virtue of or pursuant to Chapter 7 of the Medicines Act, marketing
authorisation may be withdrawn, suspended or amended (section 51, subsection 1, preamble and
letter f, of the Medicines Act).
The package leaflet must be set out in accordance with the summary of product characteristics
(SmPC) (section 4a.2, subsection 1, of the Medicines Act Regulation and article 59(1) of Directive
2001/83/EC). A consequence of this is that a new, amended package leaflet text must be submitted
simultaneously with any textual changes to the SmPC.
The text of the package leaflet must be worded in Dutch (article 4a.3, subsection 1, of the Medicines
Act Regulation). Package leaflets in several languages are permitted, provided that a declaration is
made that the information provided in all languages is the same (article 63, subsection 2 of
DIRECTIVE 2001/83/EC), with the exception of the Blue Box requirements. In the case of a package
leaflet texts in several languages, the Blue Box requirements that only apply to the other countries do
not have to be translated into Dutch. Products accepted via MRP/DCP that will not be marketed in the
Netherlands may be registered without the Dutch product information. For more information, please
refer to point 4.3 and to the Policy Document “Medicines Evaluation Board policy concerning
marketing authorisations without Dutch translations of the product information and/or mock-ups”.
For products accepted via the Centralised Procedure, in some cases there is the option to submit a
request to the MEB to market the product in question without the Dutch text on the packaging and/or
the Dutch package leaflet. Please refer to the EMA website for further information about this and the
procedure that should be followed.
The Guideline on readability dictates that a package leaflet aimed specifically at that product must be
drafted for every product. The SmPC and the package leaflet must be combined or split in the same
manner.
The
general
rule
is:
The
package
leaflet
follows
the
SmPC.
All strengths/pharmaceutical forms listed in the SmPC must also be listed in the package leaflet, even
if a product is registered in the Netherlands, but will not be marketed. In this latter case, the following
standard sentence is used in section 6: “Not all strengths/pharmaceutical forms will be marketed”. If a
strength or pharmaceutical form is marketed at a later stage, this sentence in the package leaflet can
be amended or deleted.
3. Readability
3.1 General
Article 4a.3, subsection 1, of the Medicines Act Regulation specifically stipulates that the package
leaflet must be easy to read for the user and must be worded in simple language. This is explained in
greater detail in the Guideline on readability.
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3.2 Readability test
The Board evaluates the readability of the package leaflet, to ensure that the information in the SmPC
– that is relevant to the user – is included in the package leaflet in a patient-friendly manner. The
readability test (user test) is an aid for testing the readability. Methods for setting up a readability test
have been described in the “Position paper on user testing of package leaflets” on the CMD(h)
website.
The readability of the package leaflet must be tested for new applications, renewals and for important
variations for which the text has not been defined. It is possible to refer to another tested package
leaflet by means of a bridging report (see “Guidance concerning consultation with target patient
groups for the package leaflet” on the CMD(h) website).
If a text has been defined for an innovator product (for example, by means of an Article 30
procedure), then generic companies should harmonise their package leaflets accordingly. A user test
is not deemed necessary in these cases. The generic company must demonstrate that the package
leaflet meets the requirements concerning technical readability (see point 3.3).
3.3 Technical readability
The technical readability includes characteristics of the mock-up, which can influence the readability.
These include, for example, font type, font size, use of colour, paper format and paper quality. The
Guideline on Readability has set out requirements and gives advice concerning the technical
readability in order to promote readability.
The “Form Technical declaration of readability” must be submitted for registration in the Netherlands.
This form can be found on the MEB website. For a national application this form can be submitted
together with the readability test (for the initial submission or when answering the questions from the
st
1 evaluation round). For a MRP/DCP, this can be submitted during the national implementation. It is
not necessary to include a mock-up of the package leaflet.
4. Specific Points
4.1 Information for the healthcare professionals
For parenterals and other pharmaceutical products that are generally used in hospitals, the package
leaflet may contain information for the patient and information for healthcare professionals. The
details intended for the patient and for the healthcare professionals must be clearly separated from
each other. This can be achieved in the form of two separate package leaflets (patient leaflet and
information for the healthcare professionals) but also by including the information for healthcare
professionals below a perforation line at the bottom of the package leaflet.
The MEB adopts this approach in the QRD template. If information is provided for healthcare
professionals, a note to that effect must be placed at the bottom of the package leaflet by including
the following sentence:
<The following information is only intended for doctors or other healthcare professionals.>
If the entire SmPC is supplied, it will be sufficient to include the aforementioned sentence and the
SmPC itself need not be repeated when submitting the package leaflet to the MEB.
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However, if only parts of the SmPC are added (as mentioned in the QRD template), they must be
included at the bottom of the package leaflet for the patient, with a cross-reference to section 3 of the
package leaflet for the patient.
The package leaflet and information for the healthcare professionals should be included in the
secondary packaging. Extra copies (e.g. in the form of a tear-off block) may be provided.
For parenterals that are used exclusively by the patient in the home situation, it is not necessary to
include the information for the healthcare professionals.
4.2 Patented indications
It is possible that one or more indications of the innovator products have a patent resting on them (socalled usage patent). An indication with a usage patent does not have to be included in the SmPC
and package leaflet of a generic product when it is marketed.
However, the products will be registered with the complete SmPC and package leaflet (incl. the
patented indications).
The company can then remove the patented indication from the printed SmPC and package leaflet
before the product is marketed. The marketing authorisation holder must announce this by means of a
notification.
The following should then be included in the printed package leaflet:


The standard sentence: ‘<Product name> contains <compound name> as active substance,
which has also been approved for other conditions that are not listed in this package leaflet.
Please consult your doctor or pharmacist if you have further questions.’
The following reference to the MEB website (see QRD template) (‘Detailed information about this
medicine is available on the MEB website: www.geneesmiddeleninformatiebank.nl’)
For further information, please refer to the MEB website: Generic medicinal product marketing
authorisation application > Generic medicinal products and usage patents
4.3 Marketing authorisations without Dutch translations of the product information or mockups
As medicines are not always marketed immediately after registration, the Board has decided to allow
exceptions concerning the submission of the Dutch translations of the product information.
Please refer to the “Board policy concerning marketing authorisations without Dutch translations of
the product information and/or mock-ups” for further information.
4.4. Logos and pictograms
The Board is generally reticent about allowing the use of logos, images, signs and pictograms. Signs,
images or pictograms may only be used for clarification purposes and may not be used instead of the
compulsory text. The packaging and package leaflet must meet the requirements of the Medicines
Act. If the addition of logos, images, signs and pictograms is merely a repetition of the information this
does not contribute to the clarity.
In a package leaflet of a MRP/DCP, the pictograms do not form part of the MRP/DCP package leaflet
(i.e. the content part of the package leaflet). Pictograms form part of the layout of the package leaflet
and therefore fall under the Blue Box concept (i.e. it is decided per country whether the pictograms
will be accepted).
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Pictograms and images must be evaluated by the Board. Marketing authorisation holders may not
add pictograms without prior approval from the MEB. For further information, please also refer to the
policy document “Labelling of pharmaceutical products”.
4.4.1 Preparation for Administration (Voor Toediening Gereed Maken [VTGM]) of medicinal products
for intravenous (IV) and subcutaneous (SC) administration in the home situation
Instructions must be included in section 3 of the package leaflet for medicinal products that are
prepared for administration and administered in the home situation. The inclusion of selfadministration in the home situation in the approved product information indicates that the MEB has
determined a positive benefit/risk balance. Only then does it form part of the approved medicinal
product and has it been approved by the MEB.
The patient “injects himself/herself” or the patient prepares the medicinal product for administration
and administers it via a permanent venous catheter.
The ease of use or feasibility is important in this regard and will be assessed by the MEB. Samples
may be requested, in order to gain a good impression of the actions that the patient needs to perform.
The company can use a test to demonstrate that the preparation for administration can be performed
well using these instructions. The instructions are included in the package leaflet (and therefore not in
the SmPC); after all, patients only see the package leaflet. The instructions for Preparation for
Administration and for administration must be clear and complete. Many people are visually oriented,
so supporting pictures in the package leaflet can be useful.
The supplied medicinal product should preferably contain all the required materials to prepare the
medicinal product. If the package does not contain all the required materials, this should be stated
clearly in the product information, including a list of additional materials that are required (because
they are not included in the packaging).
4.4.2 QR code
It is permitted to include a QR code on the packaging and/or in the package leaflet.
Appendix 2 at the end of this document describes the conditions that companies must meet for the
use of the QR code on the packaging and/or in the package leaflet for products that have been issued
with a national marketing authorisation. This policy also applies to parallel-imported medicinal
products and for marketing authorisations awarded via derived authorisation procedures.
The same approach applies for techniques that have the same function as the QR code.
4.5 Parallel import and Duplex registrations
4.5.1 Parallel import
Parallel import is the importation and subsequent marketing in the Netherlands of a medicine
registered elsewhere in the EU or EEA, whilst this medicine has also been registered in the
Netherlands.
In package leaflets of products marketed via parallel importation, the section on composition must be
in agreement with the information on the label and/or in the package leaflet from the country of origin.
In accordance with section 48, subsection 2, of the Medicines Act, the parallel marketing authorisation
applies for the same indications, contra-indications, adverse effects, dosages, method of use and
method of administration as the product that has already been registered. Therefore, the package
leaflet must be worded in the same manner as far as the sections on indications, contra-indications,
adverse effects, dosage, method of use and method of administration are concerned.
The other sections of the package leaflet should be similar, preferable identical in words, to the
reference product.
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NB: Package leaflet texts (as well as the SmPC) form part of an administrative decision by the Board.
Art 11, conclusion of Copyright Law stipulates that there is no copyright on administrative decisions.
If information for the healthcare professionals is added to the package leaflet of the Dutch reference
product, this must be submitted with the parallel application, along with a declaration that this is based
on the last approved SmPC of the Dutch reference product.
4.5.2 Duplex registrations
A duplex registration is a registration of a product, for which the dossier is identical to that of a product
that has already been registered. The wording of the package leaflet must be identical to the package
leaflet of the product that has already been registered (with the exception of the product specific
information such as the RVG number and the marketing authorisation holder). For more information,
please refer to the policy document “Duplex Registration” (MEB-16-5.0).
4.6 Blue Box Information for the package leaflet
For products registered via MRP/DCP or via the Centralised procedure, additional information may be
required nationally in the package leaflet or on the packaging.
In the Netherlands, apart from the RVG number, there is no specific Blue Box information for the
package leaflet.
4.7 Childproof / senior-citizen friendly packaging
The MEB is of the opinion that there is no such thing as an entirely childproof package, but only of a
deterrent package. The Board therefore considers claims concerning child safety as misleading.
Therefore, the Board will not accept claims concerning child safety on the packaging. If an application
is made during an MRP/DCP procedure concerning a claim about child safety on the packaging, this
will fall under the “blue box concept” during the procedure and this claim will not be accepted on the
Dutch packaging.
for example, the claim “Difficult for children to open” is not permitted.
Furthermore, claims relating to “senior-citizen friendly packaging” are not permitted. The term “seniorcitizen” is subjective and does not provide a proper description of the target group.
4.8 Doping warning Statement
The MEB does not agree with the inclusion of a “doping warning”, in the national version of the SmPC
and package leaflet as the doping list is not static and the warnings in relation to doping could result in
a false sense of security. Consequently, the following statements or variations thereof will not be
approved for the Dutch SmPC or package leaflet:
o
o
o
o
<X> is on the doping list.
The use of <X> can result in a positive result in a doping test.
The use of <X> as a doping agent can pose a health risk.
In laboratory tests for <xxx>, <X> can result in a false-positive result for doping tests.
4.9 EAV/EAG packaging
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EAV/EAG packages (Unit Dispensing Packaging/Unit Dispensing Suitable packaging) are intended
for hospitals and nursing homes.
It is allowed to mention EAV/EAG packaging in the national text of the packaging text, if EAV/EAG
packaging contains the same packaging materials/size as the already approved packaging mentioned
in the EU SmPC and package leaflet.
An EAV/EAG package can be included in the SmPC during the national implementation of an
application procedure for marketing authorisation or during a variation if the SmPC is involved in this
variation and the materials/size are in accordance with the information about the strips/blisters
mentioned in the SmPC. A MRP-variation is not necessary for addition of this information to the
package leaflet/packaging text. A national Article 61 (3) procedure can be used.
4.10 Impossible or difficult dosages
If the product information lists a dosage that cannot be achieved with the relevant product, this must
be stated in the SmPC and in the package leaflet.
For example, for simvastatin, the dosage varies from 5 to 80 mg per day. The following sentence can
then be included in the package leaflet of the Simvastatin 80 mg:
“Not all recommended dosages are possible with this product; however, other products with a strength
lower than 80 mg are also available”.
It can also be stated in the SmPC and the package leaflet if a patient has to use large numbers of
tablets, capsules, etc. of a product in order to achieve the recommended dose, whilst a similar product
with a higher strength is available. For example, for enalapril malate, the dosage varies from 2.5 to 40
mg per day. The following sentence can then be included in the package leaflet of the Enalapril
malate 2.5 mg:
“The recommended dosages are difficult to achieve with this product. However, other products with a
strength higher than 2.5 mg are also available, which reduces the number of tablets required each
time”.
4.11 Package leaflet for the blind and visually impaired
The marketing authorisation holder must ensure that the package leaflet can also be made available
on request by patients in formats suitable for the blind and visually impaired.
In the Netherlands, the blind and visually impaired can call the National Package Leaflet Telephone.
The patient can then listen to an audio version of the package leaflet and also request the text in
another format, such as Braille or large font.
The National Package Leaflet Telephone is an initiative by the association for the blind and visually
impaired (Viziris), representatives of the pharmaceutical industry and the MEB. If necessary,
pharmacists and chemists will inform patients about the National Package Leaflet Telephone.
Please also refer to the Guideline on the readability of the labelling and package leaflet of medicinal
products for human use by the European Commission for further information about Braille on the
packaging and the package leaflet in a format suitable for the blind and visually impaired.
4.12 Package leaflet for children
A package leaflet for children is a package leaflet specifically for children, in addition to the
compulsory package leaflet, but it does form part of the compulsory package leaflet. The aim of a
package leaflet for children is to explain the use of a medicine in a way that children can understand.
The presentation of the package leaflet for children can consist of text that can be understood by the
target group, or – for example – a cartoon story.
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The MEB is hesitant about approving package leaflets for children. For the time being, package
leaflets for children will be assessed on a case-by-case basis. The following aspects are important in
this regard:
1. Safety information should not be omitted from the package leaflet for children;
2. The package leaflet for children should meet all the requirements set for a package leaflet, should
not contradict the package leaflet for the physician and pharmacist (SmPC) and should not include
any promotional elements;
3. Adaptation of language and developmental level to the target group;
4. As the package leaflet for children forms part of the package leaflet, it also forms part of the
compulsory readability test for package leaflets.
It should be emphasised that a package leaflet for children should be viewed as a supplement to the
existing product information and not as a free-standing document.
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Appendix 1: Information on sections of package leaflet in the QRD
template
This section is included as an addition to the English and Dutch QRD template. The QRD templates
can be found on the EMA website.
Clarification is provided per section in the English annotated template. The Dutch template only
contains translations of section titles, standard sentences and examples (and not the clarification).
The Dutch QRD template follows below, listing remaining points that are not (sufficiently) discussed in
the abovementioned documents. This information is provided in frames.
Package leaflet: Information for the <patient> <user>
{(Fantasy)name, strength, pharmaceutical form}
{Active substance(s)}
 Please refer to the relevant MEB policy document (MEB-13) for the guidelines concerning the
naming of a product.
1. The complete name should be listed here. In other words, the (fantasy) name, strength and
the pharmaceutical form. In addition, the active substances must be listed on the next line.
The description of the active substances should correspond to the strength
as expressed in the name.
EG 1
Product name: Clopidogrel X 75 mg
Section 2 of the SmPC: Each film-coated tablet contains 75 mg clopidogrel (as clopidogrel besilate)
Description of active substance in the package leaflet: clopidogrel (as clopidogrel besilate)
EG 2
Product name: Risedronate sodium X 35 mg weekly, film-coated tablets
Section 2 of the SmPC: Contains 40.17 mg sodium risedronate hemi-penta-hydrate per film-coated
tablet, corresponding to 35 mg sodium risedronate or 32.5 mg risedronic acid
Description of active substance in the package leaflet: sodium risedronate
2. In the case of a combined package leaflet, the various product names are listed one below the
other.
3. The advice is to use the term “this product” instead of the product name in both the titles of the
main sections and sub-sections and the text itself in connection with the readability.
 The introduction of the package leaflet distinguishes between “taking” (e.g. tablets, drink) or
“using” (e.g. parenterals). This should be followed consistently for the entire package leaflet.
<
This medicine is subject to additional monitoring. This will allow quick identification of
new safety information. You can help by reporting any side effects you may get. See the end of
section 4 for how to report side effects.>
<Read all of this leaflet carefully before you start <taking><using> this medicine because it
contains important information for you.
- Keep this leaflet. You may need it to read it again.
- If you have any further questions, ask your <doctor><,><or><pharmacist><or nurse>.
<- This medicine has been prescribed for you only. Do not pass it on to others. It may harm them,
even if their signs of illness are the same as yours.>
- If you get any side effects, talk to your <doctor> <,> <or> <pharmacist> <or nurse>. This includes
any possible side effects not listed in this leaflet. See section 4.>
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<Read all of this leaflet carefully before you start <taking> <using> this medicine because it
contains important information for you.
Always <take> <use> this medicine exactly as described in this leaflet or as your <doctor> <,> <or>
<pharmacist> <or nurse> <has> <have> told you.
Keep this leaflet. You may need to read it again.
Ask your pharmacist if you need more information or advice.
If you get any side effects, talk to your <doctor> <,> <or> <pharmacist> <or nurse>. This
includes any possible side effects not listed in this leaflet. See section 4.
You must talk to a doctor if you do not feel better or if you feel worse <after {number of}
days.>>
What is in this leaflet
1. What X is and what it is used for
2. What you need to know before you <take> <use> X
3. How to <take> <use> X
4. Possible side effects
5. How to store X
6. Contents of the pack and other information
1.
What X is and what it is used for
 This section should list the mechanism of action of the medicine and the relevant
pharmacotherapeutic group on the one hand and the indications (in patient-friendly terms) on the
other hand. A clear distinction should be made between these.
 If the company wishes to remove the patented indication from the printed package leaflet before
the product is marketed, the following information should be included in the printed package
leaflet: “<Product name> contains <compound name> as active substance, which has also been
approved for other conditions that are not listed in this package leaflet. Please consult your doctor
or pharmacist if you have further questions.”
 For traditional herbal medicines, the indication should start with: “Traditional herbal medicine used
for …… (suggested indication(s)).” and end with the sentence: “This application is based
exclusively on traditional use and not on clinical evidence”.
<You must talk to a doctor if you do not feel better or if you feel worse <after {number of} days>.>
2.
What you need to know before you <take> <use> X
Do not <take> <use> X<:>
<if you are allergic to {active substance(s)} or any of the other ingredients of this medicine
(listed in section 6).>
 If the simultaneous use with a certain group of medicinal products is contra-indicated, inclusion of
the following sentence in this section is sufficient:
This product should not be used simultaneously with certain other medicinal products. Also refer to
“<Other medicines and X>”
It is not deemed informative for the user to list the group of medicinal products or the mechanisms
of action.
For example, if section 4.3 of the SmPC states “Simultaneous use with strong CYP3A4 inhibitors”,
the abovementioned sentence can be included in the section “Do not <take> <use> X” and a list of
the relevant medicinal products can be mentioned in the section “<Other medicines and X>”
Warnings and precautions
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 It is preferable to include a motivation as to why caution is advised (in accordance with the SmPC
or general knowledge)
For example: for acetyl salicylic acid: Do not take X if you are due to undergo a procedure that
carries an increased risk of bleeding. For example, the extraction of teeth or molars, because the
bleeding will last longer”.
 In general, all warnings should be included.
Only instructions intended exclusively for the professional group (doctor) do not need to be
included. Example: “only administer with a metal needle”.
 Herbal medicines and homeopathic products contain alcohol relatively more often. If information
about this has been included in the SmPC under “Warnings and precautions”, this should also be
mentioned in the package leaflet.
Talk to your doctor <or> <,> <pharmacist> <or nurse> before <taking> <using> X
Children <and adolescents>
Other medicines and X
<Tell your <doctor> <or> <pharmacist> if you are <taking> <using>, have recently <taken> <used> or
might <take> <use> any other medicines.>
 Only the interactions that are clinically relevant should be included. A summary of research on
other pharmaceutical products for which no interaction occurs is not deemed relevant for the
package leaflet.
 If possible, active substances may be combined in order to shorten the list.
Example: “Calcium antagonists (products for heart and blood vessels, e.g. amlodipine, nifedipine)”.
X with <food> <and> <,> <drink> <and> <alcohol>
 If information has been included in the SmPC under “Warnings and precautions” or “Interactions”
(e.g. with alcohol or grapefruit juice), then include this sub-section. This information can then be
omitted from the section “Use of X in combination with other medicines”.
 If there is no information in the SmPC, then this section can be omitted.
Pregnancy <and> <,> breastfeeding <and fertility>
<If you are pregnant or breast-feeding, think you may be pregnant or are planning to have a baby, ask
your <doctor> <or> <pharmacist> for advice before taking this medicine.>
 If no information about pregnancy, lactation and/or fertility has been included in the SmPC, no
additional information needs to be included other than the standard QRD sentence.
 If there is no specific information available for pregnancy, breastfeeding or fertility, no mention of
this is required in the package leaflet and the heading can be adapted accordingly.
Driving and using machines

Think about adverse effects such as dizziness, visual disturbances, drowsiness, etc.
The adverse effects that may be listed here should logically correspond to the adverse effects
listed in the SmPC.
<X contains {name the excipient(s)}.>
3.
How to <take> <use> X
<Always <take> <use> this medicine exactly as your doctor <or pharmacist> has told you. Check with
your <doctor> <or> <pharmacist> if you are not sure.>
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<The recommended dose is...>
<Always <take> <use> this medicine exactly as described in this leaflet or as your <doctor> <,> <or>
<pharmacist> <or nurse> <has> <have> told you. Check with your <doctor> <or> <,> <pharmacist>
<or nurse> if you are not sure.>
<The recommended dose is...>
 Duration of use:
In addition to the Annotated QRD template, it should be noted here that information from the
SmPC concerning the duration of use should be listed here. Examples:
- For chronic diseases, it is recommended to indicate that the product will be used for an extended
period.
- For antibiotics, it can be important to indication the duration of the course and that the course
must be completed.
 A sentence about the duration of action must be included in this section and not in section 1
(“What is this medicine being <used><taken> for?”). Example: “The effect starts after
approximately 1 hour and persists for 6 hours”.
 If the product information lists a dosage that cannot be achieved with the relevant product, this
must be stated in the SmPC and in the package leaflet, see Chapter 4.10. The following is an
example:
“Not all recommended dosages are possible with this product; however, other products with a
strength lower than <x> mg are also available”.
“The recommended dosages are difficult to achieve with this product. However, other products
with a higher strength than <x> mg are also available, which reduces the number of tablets required
each time”.
<Use in children <and adolescents>>
<The score line is only there to help you break the tablet if you have difficulty swallowing it whole>
<The tablet can be divided into equal doses.>
<The score line is not intended for breaking the tablet.>
<If you <take> <use> more X than you should>
 If specific advice has been included in section 4.9 of the SmPC, this should also be stated here.
For example, if the SmPC lists a possible treatment as “induce vomiting”, then this instruction
should also be stated in the package leaflet. For instructions such as “induce vomiting”, it is
recommended to add a time indication: “Induction of vomiting is most effective shortly after
ingestion, no more than 1 hour after ingestion”. The instruction “DO NOT induce vomiting” is also
important for certain products and must of course be included where necessary.
(NB: If nothing is listed in section 4.9 of the SmPC about “inducing vomiting” and the marketing
authorisation holder lists “induce vomiting” as a treatment in the package leaflet, then this will not
be accepted)
 A package leaflet established at a European level sometimes states that one should contact a
specific treatment centre (for example, the nearest toxicological centre). In the translation to the
national package leaflet, this should be replaced with “de dichtstbijzijnde spoedeisende hulp”.
<If you forget to <take> <use> X>
<Do not take a double dose to make up for a forgotten <tablet> <dose> <…>.>
<If you stop <taking> <using> X>
 In the case of antibiotics, it is preferable to indicate why the patient must finish the course: “… the
symptoms can return if all the bacteria are not killed.”
 It should be stated that the user must not stop on his/her own initiative: “Always consult with your
doctor if you are considering stopping the <use><taking> of this product”.
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 If the user may not stop suddenly, this should be stated here, for example: “You may not stop
using this medicine suddenly; you could develop problems such as … Consult with your doctor
about reducing the dosage slowly”.
 This section is not necessary for some products: for example, products for single use, such as
diagnostic agents.
<If you have any further questions on the use of this medicine, ask your <doctor> <,> <or>
<pharmacist>< or nurse>.>
4.
Possible side effects
Like all medicines, this medicine can cause side effects, although not everybody gets them.
The layout of this section is important. The use of bullet points is recommended.
It is useful – where applicable – to indicate whether a side effect only occurs at the start of the
treatment and then disappears or whether the side effects only occurs after extended treatment.
The following terminology is recommended for the frequencies. Signs such as < and > are not clear
to a patient and should be replaced with more patient-friendly terms.
Very common may effect more than 1 in 10 users*
Common
may effect up to 1 in 10 users
Occasional
may effect up to 1 in 100 users
Rare
may effect up to 1 in 1000 users
Very rare
may effect up to 1 in 10.000 users
Not known
the frequency cannot be estimated from the available data
* a choice can be made between “users” and “patients” based on the product.
In general, all side effects listed in the SmPC must also be listed in the package leaflet. When listing
the side effects in the package leaflet, it is sometimes possible to list various side effects under one
term. For example, various heart rhythm abnormalities can be summarised as “cardiac arrhythmias”.
The patient-friendly description can be followed by the medical term in brackets, for example: “tight,
painful sensation on the chest (angina pectoris)”, particularly for long descriptions of the side effect.
This should not be done for short descriptions: for example, for constipation only list the term
“constipation”. Please also refer to the List of patient-friendly terms of the MEB.
If a side effect is not immediately recognisable for a patient, then the symptoms must be included,
which will make the side effect recognisable for the patient. Please also refer to the List of patientfriendly terms.
Examples of side effects that do have to be included:
- Blood count abnormalities; these cannot be recognised immediately by a patient, but can be
recognised if the symptoms are described.
- Side effects that occur very rarely but are severe, such as anaphylactic shock, must be included.
- Side effects such as sudden cardiac death and a risk of suicide must be included. It is very important
to indicate the frequency here. Listing these side effects could have a negative effect on therapy
compliance. However, it is important to include such side effects for liability reasons and in order to
provide complete information to patients.
The following formulations will be used for these side effects:
- Sudden cardiac death: “Very rare cases of sudden cardiac arrest have been reported.”
- Risk of suicide: “There have been very rare reports of patients who developed a tendency towards
suicide (e.g. for antidepressants at the start of the treatment). You are advised to contact your doctor
immediately if you think that this applies to you.”
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Examples of side effects that do not have to be included:
- Increase in laboratory values, for example liver enzyme values, without clinical symptoms (not
immediately recognisable by the patient).
- Side effects for which a causal link has not been demonstrated.
- Side effects that are not clinically or statistically relevant. Side effects that are not clinically or
statistically relevant are side effects that are listed in the SmPC as having a frequency of occurrence
that is not statistically different from the placebo and side effects that occur very rarely and are not
severe.
<Additional side effects in children <and adolescents>>
Reporting of side effects
If you get any side effects, talk to your <doctor> <or> <,> <pharmacist> <or nurse>. This includes any
possible side effects not listed in this leaflet. You can also report side effects directly via the national
reporting system listed in Appendix V*. By reporting side effects you can help provide more
information on the safety of this medicine.
5.
How to store X
Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date which is stated on the <label> <carton> <bottle> <...>
<after {abbreviation used for expiry date}.> <The expiry date refers to the last day of that month.>
<Do not use this medicine if you notice {description of the visible signs of deterioration}.>
<Do not throw away any medicines via wastewater <or household waste>. Ask your pharmacist how
to throw away medicines you no longer use. These measures will help protect the environment.>
6.
Contents of the pack and other information
What X contains
The active substance(s) is (are)…
 List the active substance AND the quantity,
 The MEB prefers the following qualitative and quantitative representation: “the active substance is
minocycline. This is present in the form of minocycline hydrochloride, corresponding to 100 mg
minocycline”.
<- The other <ingredient(s)> <(excipient(s))> is (are)…>

The excipients should only be listed qualitatively.

If E numbers are listed in the SmPC, then the E numbers should also be included in the package
leaflet.
What X looks like and contents of the pack



The packaging material does not have to be mentioned.
If not all the packaging sizes registered in the Netherlands will be marketed, the following
standard sentence should be used in section 6: “Not all strengths/pharmaceutical forms will be
marketed”
It is possible that the package leaflet established at a European level states that a blister holder
has been added to the packaging. The blister holder allows one to carry a single blister pack/strip
instead of several blisters/strips as packaged in a box. This can be indicated using – for example
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– the sentence: “The packaging contains blisters and a blister holder”. As is the case with the
packaging sizes, the package leaflet should state: “The blister holder is not marketed in all
countries.”
Marketing Authorisation Holder and Manufacturer
{Name and address}
<{tel}>
<{fax}>
<{e-mail}>
This should be the address of the marketing authorisation holder, as listed on the marketing
authorisation. The SmPCs, package leaflets and packaging that currently still list the post (box)
address of marketing authorisation holders must be amended. This can be incorporated with other
changes to the SmPC, package leaflet and packaging texts.
 Only the logo of the marketing authorisation holder may be added, not the manufacturer, importer
or licensor or another company.
 As far as the telephone number is concerned, it should be noted that this must be the
representative’s general telephone number, to enable anyone who wishes to do so to get in touch.
Listings of special telephone numbers that redirect the caller from the representative to special
“patient information programmes” or “patient support programmes” are not permitted. For the sake of
completeness, it is pointed out that it is permitted to provide an alternative address for information and
correspondence (and the accompanying representative), in addition to that of the marketing
authorisation holder. This applies not only to the package leaflet but also to the packaging. Whether
the marketing authorisation holder is located in the Netherlands or abroad is not relevant.
This additional information to that of the marketing authorisation holder may make correspondence
and the provision of information easier, especially if the marketing authorisation holder is not based in
the Netherlands.
 The name of the distributor may not be listed, as this party is not responsible for marketing the
product.
 It is not permitted to list drugstores on the trade packaging, unless this forms part of the name as
MAH or (umbrella) brand.
 The RVG number (RVH for homeopathic products) must be included in section 6:
“This product has been registered under RVG number ……”
The listing of the RVG number falls under the Blue Box concept. For more information, please refer to
the Notice to Applicants volume 2c “Guideline on the packaging information of medicinal products for
human use authorised by the Community”.
<This medicinal product is authorised in the Member States of the EEA under the following
names:>

Also mention the product name in NL here
This leaflet was last revised in <{MM/YYYY}><{month YYYY}>.

To be completed by the MEB upon approval/registration.
<[to be implemented nationally]>
<This medicine has been authorised under “exceptional circumstances”.
This means that <because of the rarity of this disease> <for scientific reasons> <for ethical reasons>
it has been impossible to get complete information on this medicine.
{name MS/Agency} will review any new information on this medicine every year and this leaflet will be
updated as necessary.>
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<Other sources of information>
The following sentence should be included:
“Further information on this medicinal product is available on the MEB website (www.cbg-meb.nl)”
Additions by patient organisations are for the national implementation. These are not permitted in the
package leaflet in the Netherlands.
--------------------------------------------------------------------------------------------------------------------- -<The following information is intended for healthcare professionals only:>

See Chapter 4 “Special points”, section 4.1” Information for the healthcare professionals”
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Appendix 2: QR code
Introduction
The QR (quick response) code is a two-dimensional barcode. The QR code can be used to present a
website URL. The URL is encoded and printed on the outer packaging of a medicinal product and/or
in the package leaflet. Using a QR reader (application), for example on a smartphone, a scan is made
of the QR code. The app translates this scan into the URL and opens the corresponding website in
the device's browser. This provides access to (digital) information about a specific medicinal product.
The policy outlined below for the QR code in the Netherlands applies to all medicinal products for
which a national marketing authorisation is or has been issued. This policy is consistent with the
policy agreed in the CMDh for products in the mutual recognition procedure (MRP) and decentralised
procedure (DCP). This policy also applies to parallel-imported medicinal products and for marketing
authorisations issued via replica marketing authorisation procedures.
This policy only applies to the use of QR codes that refer to websites with information about the
medicinal product in question. 2D barcodes which are used solely for internal production processes
and which do not contain information about the medicinal product are not covered by this policy. The
same approach will apply to technologies with the same purpose as the QR code.
Conditions for QR code use
If a QR code is printed on the packaging and/or in the package leaflet, the conditions listed in article
69 of the Medicines Act, the policy document "Labelling of pharmaceutical products" (MEB 6) and/or
the policy document "Package leaflet of pharmaceutical products" (MEB 5) must be met. Among other
things, this entails that the QR code, and thus the underlying information, may not contradict with the
approved summary of product characteristics, must be useful for the patient and may not promote the
medicinal product. The content may not contain any public advertising.
The following information may be printed below the QR code (the so-called 'positive list'):


legal product information such as the information in the SmPC, package leaflet and labelling
information relating to pharmacovigilance, such as educational material
The form in which the information is provided is not defined, as long as the conditions regarding the
information behind the QR code are met. The information from the positive list will be made available
through the QR code by the marketing authorisation holder. The marketing authorisation holder
ensures the information on the website in question is kept up-to-date.
A QR code may be displayed on the packaging and in the package leaflet, on the condition that it is
less prominently displayed than the legally required information that is mandatory on the packaging.
For small packaging, the QR code may be applied on the inside of the packaging.
In order to make patients aware that there may be differences between the most recent approved
product information and the printed package leaflet, the following sentence should be included in the
package leaflet:
“Over dit geneesmiddel is gedetailleerde en geactualiseerde informatie beschikbaar door de QR-code
te scannen met een QR-lezer een applicatie (app) voor smartphone of tablet. Dezelfde actuele
informatie over het geneesmiddel is ook beschikbaar via de volgende URL: <…> en op de website
van het College ter Beoordeling van Geneesmiddelen (www.geneesmiddeleninformatiebank.nl)”.
The complete URL referred to by the QR code is listed under the QR code, so access to the
information is also available to patients unable to scan the QR code.
Displaying the QR code does not depend on the legal status of supply, and is allowed for both
medicinal products only available on prescription and those available over the counter.
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Procedure for including a QR code
In the application for marketing authorisation, the applicant must submit a declaration confirming that
the QR code is compliant and continues to be compliant with the imposed requirements. In case of a
DCP or an MRP, the declaration must be submitted on D106 at the latest. For a national procedure,
the applicant must submit the declaration no later than the second round. Any later during the
application procedure for marketing authorisation a declaration will no longer be accepted.
With this declaration, the applicant confirms that the content of the QR code is and shall remain in
accordance with applicable regulations. If a marketing authorisation has already been issued for a
medicinal product, the addition of a QR code may be submitted via an article 61(3) notification.
Furthermore, the addition of a QR code may also be submitted together with another change to the
product information in a type IB or type II variation of the C category or during a renewal.
For parallel-imported medicinal products, the QR code from the original supplier must be taped over.
Documentation to be submitted
The following documentation must be submitted when applying for a QR code on the packaging
and/or in the package leaflet:
1. Completed QR code declaration:
- For MRP/DCP procedures: “Annex 2 - Applicant’s declaration template”
(http://www.hma.eu/90.html)
- For National procedures: “Application for the inclusion of QR code in national procedures”
(can be found on the MEB website, www.cbg-meb.nl)
2. Mock-ups of packaging and/or package leaflet (depending on where the QR code is
presented) in actual size.
3. Package leaflet: Please note that the following text must be added: "Over dit geneesmiddel is
gedetailleerde en geactualiseerde informatie beschikbaar door de QR-code te scannen met
een QR-lezer, een applicatie (app) voor smartphone of tablet. Dezelfde actuele informatie
over het geneesmiddel is ook beschikbaar via de volgende URL: <...> en op de website van
het College ter Beoordeling van Geneesmiddelen (www.geneesmiddeleninformatiebank.nl)"
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