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21 November 2016 EMA/QRD/752627/2016
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QRD guidance on the use of approved pictograms on the packaging of veterinary medicinal products authorised via the centralised (CP), mutual recognition (MRP) and decentralised procedures (DCP)
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Draft
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Draft agreed by Quality review of documents (QRD) Adopted by CVMP and CMDv for release for consultation Start of public consultation End of consultation (deadline for comments)
October 2016 November 2016 25 November 2016 25 February 2017
8 Comments should be provided using this template.The completed comments form should be sent to
[email protected] 9 Keywords
Pictograms, target species
30 Churchill Place ● Canary Wharf ● London E14 5EU ● United Kingdom Telephone +44 (0)20 3660 6000 Facsimile +44 (0)20 3660 5555 Send a question via our website www.ema.europa.eu/contact
An agency of the European Union
© European Medicines Agency, 2016. Reproduction is authorised provided the source is acknowledged.
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QRD guidance on the use of approved pictograms on the packaging of veterinary medicinal products authorised via the centralised (CP), mutual recognition (MRP) and decentralised procedures (DCP)
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Table of contents
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1. Introduction ............................................................................................ 3
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2. Definitions ............................................................................................... 3
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3. General characteristics of pictograms ..................................................... 3
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4. Requirements for pictograms taken from Annex 1 .................................. 4
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4.1. Using pictograms from Annex 1 to substitute text on the packaging ........................... 4
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4.1.1. Further considerations specific to pictograms of target species ................................ 4
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4.2. Using pictograms from Annex 1 to accompany text on the packaging.......................... 4
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4.3. Replacing existing pictograms by agreed pictograms from Annex 1 for approved products .................................................................................................................... 4
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5. Mechanism to introduce pictograms from Annex 1 .................................. 4
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6. Maintenance of pictograms in Annex 1 .................................................... 5
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Annex 1 – Approved pictograms .................................................................. 6
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Section 1 ................................................................................................................... 6
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Section 2 ................................................................................................................... 8
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QRD guidance on the use of approved pictograms on the packaging of veterinary medicinal products authorised via the centralised (CP), mutual recognition (MRP) and decentralised procedures (DCP) EMA/752627/2016
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1. Introduction
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The safe and correct use of veterinary medicines depends on users being able to accurately read and
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understand the information on the packaging. Therefore, the main purposes of the labelling are the
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unambiguous identification, traceability and correct use of the veterinary medicinal product. Marketing
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Authorisation Holders (MAH) must make best use of the available space on the packaging to ensure
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that all the information is clear and legible, taking into consideration the typical environments or
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situations in which the product will be used. The use of pictograms in general is optional. Pictograms
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can be useful as long as the meaning and size of the graphic are clear. The need for a harmonised,
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approved ‘catalogue’ of pictograms was identified:
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to improve predictability of approval by regulators when the use of pictograms is proposed;
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to embed and thereby improve the meaning of these harmonised pictograms for users of
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veterinary medicines.
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This guidance has been developed together with industry stakeholders. The use of pictograms from
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Annex 1 as defined in this guidance will apply to the national authorisation procedures, including MRP
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and DCP, as well as to the centralised procedure (EMA). The aim of the guidance is to outline the
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approval requirements and process for two situations where either:
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pictograms from section 1 of Annex 1 are proposed to substitute text on small, immediate packaging/blisters or;
pictograms from Annex 1 are proposed to accompany text on the labelling/package leaflet.
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2. Definitions
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Within this guidance, pictograms are defined as standard approved symbols that unambiguously
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convey a piece of information or an instruction. These pictograms are distinctive to any other
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images/graphic representations defining a Marketing Authorisation Holder e.g. logo, brand-specific
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images.
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3. General characteristics of pictograms
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As a general requirement, pictograms should be clearly distinguishable from the background i.e. good
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contrast. Pictograms taken from Annex 1 should specifically be printed in black and white, as shown.
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The use of a highly glossy or metallic reflective colour is not recommended as it may affect clarity.
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No visual effects such as shading should be used in the pictogram.
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The size of the pictograms should be proportionate to the size of the printed surface/label. Pictograms
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may not be less than 5 mm, which may be waived in exceptional circumstances for very small packs;
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the approval of pictograms smaller than 5 mm will be a matter of assessment on a case-by-case basis.
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The location of the pictograms should not negatively affect the readability of the mandatory
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information on the packaging (e.g. if the pictogram is too close to text it can impact on readability).
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Pictograms should exclude any element of a promotional nature.
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4. Requirements for pictograms taken from Annex 1
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4.1. Using pictograms from Annex 1 to substitute text on the packaging
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If pictograms are used to substitute text on the packaging, it is considered compulsory to use those
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provided in section 1 of Annex 1, i.e. the use of proprietary pictograms not in this ‘catalogue’ would
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not be approved in the case of substitution of text.
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The pictograms from section 1 of Annex 1 of this guidance can only be used to substitute text on
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small immediate packaging units (as defined in the QRD product information template) and blisters.
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Pictograms in section 2 1 of Annex 1 may not be used to substitute text, i.e. they may only be used in
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addition to (alongside) the required text.
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4.1.1. Further considerations specific to pictograms of target species
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In particular for target species, pictograms cannot be used to replace text such as the age, sex or size
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of the animal, therefore pictograms will always represent the species and not the sub-species.
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Images/graphic representations that are not part of a brand-specific design, which could be interpreted
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as target species on the outer packaging should be consistent with the approved pictograms used on
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the immediate packaging as listed in section 1 of Annex 1, as well as consistent with the content of
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the product information, in order to avoid confusion to the user.
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4.2. Using pictograms from Annex 1 to accompany text on the packaging
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As a general principle, the pictograms in Annex 1 may be included on the labelling/package leaflet in
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addition to (alongside) the corresponding text that they are representing.
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4.3. Replacing existing pictograms by agreed pictograms from Annex 1 for approved products
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To ensure harmonisation and to establish a common understanding of pictograms by the user, it would
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be preferable that any existing pictogram currently authorised as a substitution for text is replaced by
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an approved pictogram from section 1 of Annex 1. Where existing pictograms are currently used
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alongside the text that they represent, it is equally encouraged to replace them with an approved
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pictogram from Annex 1 using the mechanisms described in section 5.
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5. Mechanism to introduce pictograms from Annex 1
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For new marketing authorisation applications, any proposed use of pictograms from Annex 1 should be
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indicated in the product information within the initial submission or as soon as possible during the
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ongoing procedure. For authorised products, requests to make use of pictograms from Annex 1 can be
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made during another procedure affecting the product information i.e. when the product information is
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‘open’ for review in the context of another procedure. Alternatively, a stand-alone variation application
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may be introduced using classification C.II.6.b 2 (Type IB).
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Section 2 is currently empty at the time of publication
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Variation classification guideline 2013/C 223/01: link
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In order to indicate its intended use to assessors, any pictogram should be inserted within the product
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information, as follows:
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If substitution of text by a pictogram from section 1 of Annex 1 is proposed (N.B. substitution
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only currently possible for small immediate packaging units/blisters), insert the pictogram
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within the respective section of Annex IIIA (Labelling) in the product information (QRD)
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template without the accompanying text. Furthermore each pictogram from section 1 of
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Annex 1 used as a substitution to text on small immediate packaging units/blisters should also
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appear in the relevant section of the package leaflet, both in Annex IIIB of the product
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information (QRD) template (and on the printed leaflet), close to the text it substitutes on the
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small immediate packaging unit/blister, to reinforce and clarify the meaning of the pictogram.
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If a pictogram is intended for use in addition to the text, insert the pictogram with the accompanying text within the respective section(s) of the product information (QRD) template.
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6. Maintenance of pictograms in Annex 1
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Requests for new pictograms (currently limited to the category of target species at the time of
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publication), should be endorsed within industry associations where possible and then submitted to
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both the CMDv and QRD secretariats for regulatory approval:
[email protected] and
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[email protected]. The newly-requested pictogram must be approved by these regulatory bodies
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before its use in any submission under the terms of this guidance.
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Annex 1 – Approved pictograms
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Section 1 Target species Species
Pictogram
Location of image to download
Pig Link
Cattle Link
Sheep Link
Chicken Link
Rabbit Link
Horse Link
Goat Link
Dog Link
QRD guidance on the use of approved pictograms on the packaging of veterinary medicinal products authorised via the centralised (CP), mutual recognition (MRP) and decentralised procedures (DCP) EMA/752627/2016
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Species
Pictogram
Location of image to download
Cat Link
Turkey Link
Goose Link
Duck Link Fish Link
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Section 2
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This section is currently empty at the time of publication.
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