Product Literature Standard (PLS) for veterinary medicines

Introduction

The Product Literature Standard (PLS) should be taken into account when creating mock-ups for assessment.

Taking note of the following will greatly enhance your chances of getting your mock-ups right first time:

• Follow the approved QRD text (if available) or the approved SPC (if no QRD) and information in this document
• If you wish to deviate from the above, contact the relevant authority before submitting mock-ups
• Deviating from the above will only be permitted in very exceptional circumstances – it is up to you to agree the wording during the assessment phase of the application procedure and / or before the mock-up review process
• Minor deviations are permitted to correct grammatical errorserrors.
• If you are asked to make changes, please make them and do not make any other changes without agreeing it with the relevant authority firstfirst.

Joint labelling with Ireland

Joint labelling could be achieved between GB and IE, NI and IE or all 3 - GB, IE and NI. You can apply either at the end of a new MA procedure or retrospectively for existing MAs, whether authorised by EU or national procedures.

To obtain joint labelling, the SPC/QRD must be identical in both the UK and IE. This can be achieved by applying for a harmonisation variation in both countries. To maintain joint labelling the SPC/QRD must remain harmonised.

Please also see further guidance on acceptable additional information permissible on the labelling and package leaflet of veterinary medicines jointly labelled for the UK and Irish market (PDF, 212 KB, 8 pages).

See Joint labelling for veterinary medicines for use in the UK and Ireland.

Definitions

Type	Details to appear
Immediate Packaging	The label on the container or any other form of packaging that is in direct contact with the veterinary medicine. The immediate packaging does not include capsules which are administered as part of the product.
Outer Carton/PackagingCarton	The packaging into which the immediate packaging is placed.
Label	Information on the immediate or outer packaging.
Package Leaflet	The leaflet that contains information for the user which accompanies the product.
Product Literature	Consists of labelling for the immediate packaging, outer packaging and package leaflet.
Summary of Product Characteristics (SPC)	Contains information on the product as agreed during the course of the assessment.
Mock-up	A flat artwork design in full colour, presented so that it provides a full-size replica of both the immediate, outer packaging and package leaflet so that the three dimensional presentation of the label text is clear.

Templates

You must provide draft QRD text using the appropriate template. For initial nationalGB or NI-national only Marketing Authorisations (MAs) validated on or after 2928 AprilJanuary 2024,2022, you must use the  revised national productSPC/QRD information template (MS Word Document, 85.751.7 KB). An annotated version of this template (PDF, 444391 KB, 3632 pages) is available which provides supporting guidance on the information requirements listed.

For national MAs granted or validated before 2928 AprilJanuary 2024,2022, you may continue to use priorthe versions of this template, available here:

• For MAs validated before 28 January 2022, the original national product information template (MS Word Document, 58.9 KB)
• For MAs validated after 28 January 2022 but before 29 April 2024, the v.1 (MS Word Document, 56.458.9 KB) or v.2 (MS Word Document, 52.9 KB) national product information template. V.1 was updated on 13 June 2023 to simplify requirements for the outer and immediate labelling
• For national MAs, you should update and implement the product information in line with the v.3 template by 1 April 2029.

.

For mutually recognised MAs whereyou NImust isuse Concernedthe Membertemplate Stateprovided (CMS),in guidance on QRD templates is available from the EMABest website.Practice Guides.

See Summary of Product Characteristics and product literature for veterinary medicines for more information on the application process relating to mock-ups in the UK.

Before you create mock-ups

The amount of space you have available on packaging should be considered from the outset and throughout the assessment process. The amount of text included on the QRD must reflect the size of the label.

If you are concerned about fitting the agreed text onto your packaging you must discuss this with the relevant assessor during the assessment phase before the QRD text is agreed.

Designing mock-ups

The following should be taken into consideration during the design of mock-ups.

Font type and size:

• font type should be easy to read and not overly stylised, which can be difficult to read
• choose a font that clearly distinguishes between similar characters such as i, l and 1
• capitals should be avoided but can be used to emphasise words
• Italics should be used for Latin terms when citing correct nomenclature and microorganisms
• font size should be as large as possible and must be clearly legible to the user. Font size should be measured against Times New Roman. If you can’t use the recommended font sizes list below, please include a justification for this when submitting mock-ups

Type of Packaging	Recommended Font Size	Minimum Font Size
Small Immediate Pack Sizes	7 pt	4.75 pt*
Immediate Packaging	7 pt	6 pt
Outer packaging	7 pt	7 pt
Package Leaflet	9 pt	8 pt

*only in exceptional circumstances and on a case-by-case basis.

Colour

• colours should have a good contrast between the text and the background
• legibility of information should not be compromised by the colours chosen. Preferably, dark text should be printed on a light background, but the reverse may also be applied in certain circumstances, such as to highlight a particular warning

Design and Layout

• legibility of information should not be compromised by design. ConsiderConsider, whether the layout, font size and legibility has been fully optimised
• where possible line spaces should be kept clear which enhances clarity
• column text formatting is acceptable but the margin between columns should be large enough to separate the text clearly
• if space is limited a vertical line may be used to separate text. Related information should be kept together so that information flows from one column to the next

Headings

• bold type and different colour headings can help information stand out and users navigate the text
• spacing above and below the headings should be consistent throughout the packaging
• avoid using multiple headings as using more than two levels may cause confusion
• use of QRD headings on the immediate and outer packaging is not obligatory, but you must include headings that clearly convey meaning, such as ‘withdrawal period’

Use of Images and Symbols

• you can include clear diagrams and images in addition to wording, provided they are not misleading or cause confusion
• symbols and images can be useful provided the meaning is clear and that the size of the image is legible

SharedLabelling labelling with other countriesrequirements

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Multilingual Labels

Multilingual labels refersand topackaging themust usehave ofEnglish twotranslation orand moreeach languagesdifferent forlanguage atshould leasthave onea componentclear ofseparation. theAll packaginginformation material.provided in each language should be kept together. The inclusion of multiple language text must ensure that:

• requirements of the VMD are respected
• legibility of the English text is not compromised
• information given is identical in all languages. The VMD will only assess the English text on the label

ExceptionMulticountry Labels for Marketing Authorisations Granted under the Centralised Procedure Labels

For veterinary medicines authorised under the Centralised Procedure in the EU and where aan labelidentical isGB sharedmarketing withauthorisation/application GB,has been issued or received, the VMD will allownot youenforce Veterinary Medicines Regulations 2013 (VMR) Schedule 1 Part 7, paragraph 50 (1) as it has affect in GB in regards to omitinclusion  theof all product information on the package leaflet when this cannot be presented on the immediate or outer packaging. Specifically, the VMD will not enforce a requirement for inclusion of the name and address of the GB marketing authorisation holder/distributor (if different to the EU marketing authorisation holder information)information), and the GB Vm number on the accompanying package leaflet,leaflet.

Instead, subjectif the name and address of the GB marketing authorisation holder/distributor (if different to thisthe EU marketing authorisation holder information), and the GB Vm number are not included on the package leaflet, information appearingspecific to GB are to appear in athe national‘Blue specificBox’ box onon the outer packaging (or immediate packaging if no outer packaging).

The country abbreviations GB or UK(GB) and UK(NI) are acceptable for use on all packaging and leaflets. The abbreviation ‘XI’ for Northern Ireland should not be used.

Labelling

For requirements

example:

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Dual eachLabelling

Mock-ups blisterare pocket,assessed therefore,nationally randomwith displaysno ofcommunication informationbetween shouldother appearNational frequently.Competent ItAuthorities.

All isnational acceptablerequirements towill applybe the batch number and expiry date at the end of the blister.applicable.

NationalThe specificMAH information should be includedaware in the country specific box on shared labels. This should include any information that is specific to that country only. Any information thatin appliesall tolanguages bothmay countriesnot shouldremain beconsistent includedif invariations theare main text outside this box.submitted.

Strength and total content

Sometimes packaging may need to include both quantity per unit volume and total quantity per total volume. Different strengths of the same product should be expressed in the same format.

Unless space is limited, micrograms should be spelt out in full. Trailing zeros should not be used, for example 2.5 mg not 2.50 mg.

Company websites

You can’t refer to company websites. You can include an email address and/or telephone number.

Anthelmintics

In the UK, we have a voluntary labelling scheme for the inclusion of chemical group symbols on sheep anthelmintics. You can also use the scheme for other species.

Through the use of approved symbols, users can easily identify the chemical group which helps efforts to delay the development of anthelmintic resistance. The symbol should in a prominent position on the outer carton, immediate label and package leaflet.

A minimum diameter of 10 mm is suggested for the symbol on the outer carton, which can be scaled up for larger presentations.

No symbol is required for narrow spectrum anthelmintics such as closantel.

QR Codes

A QR code or 2D barcode may be added providing legibility of the required text is not compromised and only accesses:

• information intended for internal manufacturing processing, stock control or anti-counterfeit measures that cannot be accessed by the public
• public information which conforms to the VMD (or HPRA for joint labels) approved product information (Summary of Product Characteristics, label or package leaflet for that product). Links to company websites are considered promotional and cannot be included.

To add a QR code to existing packaging you will need to submit a G.I.15.zType VariationIB Requiringvariation. Assessment. The variation must include a detailed account of information to which this code links and any significant changes to this information would require the submission of a further variation.

Once a QR code has been approved the MAH is responsible for ensuring that the information included in the QR code is in line with the approved SPC.

Product ranges

There should be a separate SPC and product literature for each strength and pharmaceutical form of a veterinary medicine.

You may be able to combine package leaflets for products that are different strengths and/or different pharmaceutical forms. If a combined package leaflet is required, this should be raised during the assessment phase when the QRD text is being agreed and before the mock-up review process.

A combined package leaflet will only be agreed if the contents are identical for each product and the combination does not cause confusion for the user.

Mock-ups requirements

This section describes the specific details that must appear on each of the different packaging types.

If you cannot fit all the required information on the relevant packaging, and an outer carton is used, you should include the statement “Keep the container in the outer carton” on all product literature.

If space is available, you may be asked to include extra information especially in the case of Provisional and Limited Marketing Authorisations.

You can also download a check-list table (PDF, 178 KB, 4 pages) of the following requirements.

Names and addresses of MAH, site of batch release and distributors

Details to appear	Packaging type
Name only or company logo	OuterBlisters Packaging,or Immediate PackagingStrips
Name and address	Package Leaflet, Outer Packaging, Immediate Packaging, Label if no leaflet
Batch release site if different to the MAH	Package Leaflet, Label if no leaflet

Where several company names and addresses appear, the role of each should be clear. If space is limited the addresses can be shortened; however, it must include the name of the country if outside the UK (or Ireland for joint labels).

A local representative may also be includedincluded, on the package leaflet and label if no leaflet, but this is not a legal requirement.

You may include the details of a named distributor on your labels instead of, or as well as the MAH details.

Product name followed by its strength and pharmaceutical form

This information must match the SPC/QRD and appear on each packaging type. The whole product name should appear together. Only the invented name is required on small immediate packaging.

Copyright or trademark symbols are allowed.

Name and quantity of the active substance and the name of any excipient

Details to appear	Packaging typetype:
NameIf and quantity of the active substance and excipients if shown in Section 2 of the SPC	Package Leaflet, Outer Packaging, Immediate Packaging, Label if no leaflet
Name and quantity of the active substance and quantity	Small Immediate Packaging, Outer Packaging
QuantityName of the active substance	SmallBlisters Immediateor PackagingStrips

Indications, dosage and adverse reactions

Details to appear	Packaging type
Pharmaceutical form (Not required if it forms part of product name)	Package Leaflet, Outer Packaging, Label if no leaflet
Indications: Non-prescription product	Package Leaflet, Outer Packaging, Immediate Packaging, Label if no leaflet
Indications: Prescription products	Package Leaflet, Label if no leaflet
Contraindications	Package Leaflet, Label if no leaflet
Adverse eventsReactions: Include the statement “If you notice any serious effects or other effects not mentioned in the package leaflet, please inform your veterinary surgeon.”	Package Leaflet, Label if no leaflet
Target Species: For small immediate packaging itor isblister stronglystrips recommendedthe totarget includespecies amay pictogramappear either as part of the targetproduct speciesname, separately, or replaced by a clear pictogram. Further guidance on the use of pictograms has been produced by CMDv	Package Leaflet, Outer Packaging, Immediate Packaging, Label if no leaflet
DosageDosage: If there is a package leaflet	Package Leaflet,Leaflet
Dosage: If there is no package leaflet	Outer Packaging, Immediate Packaging, Label if no leaflet

Route of administration, dates and warnings

The method or route of administration should be written as per the SPC. Standard abbreviations are acceptable on small immediate packaging or on the outer packaging provided that full terminology is used on the package leaflet. Non-standard routes should be written out in full.

Details to appear	Packaging / Leaflet type
Route of administration	Outer Packaging, Immediate Packaging, Package Leaflet, Label if no leaflet
Advice on correct administration	Package Leaflet, Label if no leaflet
Withdrawal period: For food producing species the withdrawal period, as per the agreed QRD should be shown even if it is zero hours/days	Package Leaflet, Outer Packaging, Immediate Packaging, Small Immediate Packaging, Label if no leaflet
Special storage instructions	Package Leaflet, Outer Packaging, Immediate Packaging, Label if no leaflet
Special warnings: Warnings as per the following sections of the SPC – 3.4,4.4, 3.5,4.5, 3.7,4.7, 3.8,4.8, 3.10,4.10 3.11 and 5.16.2	Package Leaflet, Outer Packaging, Immediate Packaging, Label if no leaflet
Disposal advice: As written in Section 5.56.6 of the SPC unless otherwise agreed in the QRD. If agreed during assessment, additional national disposal and environmental warnings may also need to be included on the packaging	Package Leaflet, Outer Packaging, Label if no leaflet
TheDate statement:package ‘Findleaflet morewas productlast informationapproved: byEU searchingApplications for– theLast ‘Productday Informationof Database’assessment onphase. www.gov.uk.’National ThisApplications statement– isDate onlyof requiredissue. whereGB-national referenceapplications tocompleted thein Unionparallel Productwith Databasean isNI-MRP/DCP alsoapplication included.- date the EU procedure concluded	Package Leaflet, Label if no leaflet
Other information: Further information required in the MA	Package Leaflet, Label if no leaflet
Batch Number, preceded by the word “Lot”Number	Outer Packaging, Immediate Packaging, Small Immediate Packaging, Blisters or Strips, Label if no leaflet
Expiry Date: The expiry date should be written clearly to avoid confusion. Dates may be printed, embossed or engraved into the packaging. If this is overprinted onto the final printed mock-up this should be clarified to the competent authority	Outer Packaging, Immediate Packaging, Small Immediate Packaging, Blisters or Strips, Label if no leaflet
The in-use shelf life (if appropriate) should be listed on multidose containers ≥ 50 ml.	Outer Packaging, Immediate Packaging, Small Immediate Packaging, Label if no leaflet

Intended use

Details	A suitable space to appear	Packagingrecord /the Leafletdiscard type
date (if relevant). The wordsfollowing ‘Forstatement animalshould treatmentbe only’	Outerincluded: Packaging,“When Labelthe ifcontainer nois leaflet
Thebroached/opened wordsfor “Keepthe outfirst oftime, using the sightin-use andshelf reachlife ofwhich children”is specified on this package leaflet, the date on which any product remaining in the container should be discarded should be determined. This discard date should be written in the space provided on the label.”	Outer Packaging, Package Leaflet, Label if no leaflet

Intended use

The words “Read‘For theanimal packagetreatment leafletonly’ beforeshould use” Outerappear Packaging,on Immediateeach Packaging packaging type.

Marketing Authorisation details

Details to appear	Packaging / Leaflet type
PackageContent sizeby weight, by volume or by number of doses	Package Leaflet, Outer Packaging, Immediate Packaging, Small immediate packaging, Label if no leaflet
ClassificationThe ofdistribution category should appear in a box. Prescription products should include the following statement: “To be supplied only on veterinary medicine,prescription”. includingFor Joint labels, UK only: Whilst it is not mandatory, we strongly encourage you to also include this on the distributionsmall category.immediate Thepackaging. For Joint labels, IE only: It is mandatory to include the distribution category shouldon appearthe insmall aimmediate box.packaging.	Package Leaflet, Outer Packaging Immediate Packaging, Small immediate packaging (IE only), Label if no leaflet
The words ‘Keep out of the sight and reach of children’	Package Leaflet, Outer Packaging, Label if no leaflet
The marketing authorisation (MA) number. TheWhilst packageit leafletis andnot labelmandatory, ifwe nostrongly leafletencourage shouldyou to also containinclude athis liston ofthe authorisedsmall packimmediate sizes.packaging.	Package Leaflet, Outer Packaging, Immediate Packaging, Label if no leaflet

For sharedJoint labels, where possible and when space allows, country specific information should appear in a box like this on mock-ups:

In Ireland the package leaflet should also state the method of sale and supply in full.

Diluent label

The minimum amount of information which should appear on a diluent label:

• Name of diluent: The ‘trade’ name with a brief description or a more descriptivedescribing way of naming (Solvent /diluent for type of vaccine it can be used with or properties of the diluent)
• TargetContent speciesby weight, by volume or by number of doses
• Route(s) of administration: The statement ‘Read the package leaflet before use’
• Storage conditions: For example: Store below 25ºC
• Batch Number
• Expiry Date
• NameThe orwords company“For logoanimal oftreatment only”
• Vm/VPA number: For joint labels
  • UK only: Whilst it is not mandatory, we strongly encourage you to include this on the Marketingdiluent Authorisationlabel.
  • IE Holderonly: It is a mandatory requirement to include the MA number on the immediate packaging. While it is not mandatory to include this information on the small immediate packaging, we strongly encourage you to do so

Veterinary Homeopathic Registrations

TheIn labelsaddition ofto athe registeredrequirements above Veterinary Homeopathic productRegistered mustproducts haveshould thealso following:include:

• Clear mention of the words “homeopathic remedy without approved therapeutic indications for veterinary use”
• Scientific names of the stock(s) followed by degree of dilution using symbols of pharmacopoeia. If product is composed or more than one stock, the packaging may need to mention an invented name in addition to the scientific names of the stocks
• Name orand companyaddress nameof andregistration holder and, if appropriate, the permanentmanufacturer. addressThe ormanufacturer registereddoes placenot ofneed businessto ofbe theincluded registrationon holdersmall andcontainers, ofup theto manufacturer50 ml
• Method and, if necessary, route of administration. The route of administration should be included on small containers, up to 50 ml.
• Expiry date
• Pharmaceutical form
• Contents of thesale packpresentation
• Special storage precautions
• Withdrawal period,period where applicable, or a statement if the product is contraindicated for animals intended for human consumption
• Target species
• A special warning for the product, if necessary
• Manufacturers batch number
• UK only: a registered product will have registration number preceded by the symbol Vh on the labels
• IE only: A registered product will have a registered number in the following format: HoVR 01/001

Controlled Drugs

Products containing controlled drugs listed in Schedule 2 or 3 of the Misuse of Drugs Regulations 2001 must be clearly identified with “CD” either in a triangle (preferably) or in a box with the relevant schedule below.

The CD symbol should be included on labels (where space permits), outer packaging and on the package leaflet. This does not need to be included on blister packs or small immediate labels.

Exceptional Marketing Authorisations (MAs)

Exceptional MAs are subject to normal labelling requirements, but are also required to include the following information on the packaging:

• A clear statement that the product does not have a full Marketing Authorisation and to highlight areas of ‘weakness’. For example: “This is a Limited Marketing Authorisation. A full set of supporting safety and efficacy data is not available for the product”
• The statement “All suspected adverse reactions and any suspected lack of efficacy should be reported to [company pharmacovigilance phone number and address]”
• The statement “Further information on this product and its supporting data can be found on Product Information Database”

Parallel Import Marketing Authorisations (MAPI)

MAPIs are subject to normal labelling requirements but must also include the following information on the packaging. A photograph of the over-labelled product may be requested to ensure that any foreign text which does not comply with the UK requirements is not visible.

• MAPI holder name and address: ‘Manufactured by (name of original MAH)’, ‘Procured from within the EU and repackaged by the licence holder’ (Name and address of MAPI holder’
• Adverse reactions: The MAPI holder must provide a UK telephone number for reporting adverse events.
• Batch Number: The original manufacturers batch number should be included
• Expiry Date: The original manufacturers expiry date should be included

It is the importer’s responsibility to give notice to the original MAH or trademark owner before the repackaged product is put on sale, and, on demand, supply the original MAH with a specimen of the repackaged product. The VMD do not assess or provide comment on the presence or absence of the respective company logos.

Dedicated Dispensing Containers

If submitted to the VMD with the authorised packaging, they are considered to form part of the authorised packaging and will be subject to the same level of mock-up assessment.

Mock-ups assessment

Mock-ups supplied in support of an application to the VMD must be in accordance with the Product Literature Standard and presented as a flat artwork design in full colour. We will assess all mock-ups submitted in support of a national GB and/or NI application. This includes assessment of mock-ups for GB national applications submitted in parallel to an EU centralised procedure.

Mock-ups are assessed against the agreed QRD text and SPC, the Product Literature Standard and any other information provided by or discussed with you.

Mock-ups submitted should not deviate from the agreed QRD text and/or SPC. However, in exceptional cases, you may be allowed to deviate but you must contact us to discuss this before submitting your mock-ups. Not doing so will delay the approval of your mock-ups and subsequent issue of the application.

The following are not assessed and should not be submitted with applications:

• shipping packs
• datasheets, including Material Safety Data Sheets (MSDSs)
• packaging for wholesalers that do not include any labels
• display packaging
• promotional material
• dispensing envelopes are not required. However, if submitted to the VMD with the authorised packaging, they are considered to form part of the authorised packaging and will be subject to assessment

No mock-ups

If you do not want to submit mock-ups (for certain pack sizes), or mock-ups are not submitted within the deadlines set, your application will be issued with a condition that mock-ups will need to be submitted for assessment under cover of a national G.I.15zG.I.15 variation requiring assessment (VRA), prior to marketing.

Mock-up changes that require a variation

Any changes not already covered by a specific variation classification that may affect the legibility of the mock-up must be approved by way of a national G.I.15zG.I.15 variation requiring assessment (VRA), for example:

• new corporate design of packaging
• new container type / size
• changes to the layout of the package
• introduction of multilingual packs for an already approved authorised product
• introduction of mock-ups for an authorised pack size

You should only submit the mock-ups for the packaging/labelling that is affected.

Notifications

Minor mock-up changes that do not affect the font size, layout or legibility do not require a variation, for example a change to the barcode, logo (assuming same size), change of IE national specific text.

If you are in doubt about whether a variation is needed, please contact notification@vmd.gov.uk or vetinfo@hpra.ie.

WeIf willthe thenVMD confirmagrees ifthat thisno variation is acceptablerequired, orwe ifwill aconfirm variationthis iswith requiredyou and make a note of the changes in our records. This does not mean the VMD has assessed or approved the described change(s) only that they can be made without the need for a variation. You are not required to submit revised mock-ups to the VMD but they can help to clarify the change.

Assessment timescales

Mock-ups will be assessed within 20 days of receipt of correct versions.

If only minor amendments to existing approved mock-ups are needed we will annotate your existing approved mock-ups, otherwise new mock-ups will be requested. You will be notified of this within 4 days of the procedure ending.

If the mock-ups contain errors, or are not suitable, you will receive a comments document listing any proposed changes. You should update the mock-ups to incorporate the proposed changes and return revised versions as soon as possible.

You will only receive 1 comments document. If the revised mock-ups are still incorrect a condition will be applied to the authorisation to introduce corrected mock-ups under the cover of a suitable national variation prior to marketing.

See Joint labelling for veterinary medicines for use in the UK and Ireland for specific guidance.