Veterinary product information templates | European Medicines Agency (2024)

The European Medicines Agency's (EMA) providestemplates for product information for use by applicants and marketing authorisation holders of veterinary medicines. EMA's Working Group on Quality Review of Documents (QRD) develops, reviews and updates these templates.

The information contained in these documents is non-exhaustive. Companies should refer to all relevant European Union legislation and guidelines when drawing up applications. It is the company's responsibility to ensure that the product information complies with all applicable requirements.

Applicants should use:

Template v.8.2 for applications (initial and post-authorisation) validated before 28 January 2022;
Template v.9 for initial marketing authorisation applications validated on or after 28 January 2022.
Combined label-leaflet v.9.0 for when there is no package leaflet and all information is then required to appear on the outer packaging (Art. 14(4) of Regulation (EU) 2019/6

Current template (v.9)

Product information template v.9 supports the requirements of the VeterinaryMedicinal ProductsRegulation(Regulation (EU) 2019/6), which applies from 28 January 2022.

Template v.9contains:

a new structure of the SPC,labelling and package leaflet with the order of sections in the package leaflet and in the SPC aligned as far as possible;
information only to be included in the package leaflet that was formerly in the labelling, to simplify the outer and immediate labellingand emphasise the importance of reading the package leaflet;
a consolidated section on ‘minimum particulars to appear on small immediate packaging units' which now incorporates blisters and strips. This does not contain any mandatory information requiring translation;
a new sectionon any restrictions on the use of antimicrobial and antiparasitic veterinary medicines, to promote prudent use of antimicrobials andlimit the risk of development of antimicrobial resistance. This includes restrictions onconditions of use that arenot in accordance with the terms of the marketing authorisation, i.e. restrictions on conditions for the so-called ‘cascade’ use of certain veterinary medicines;
expanded guidance text in many sections to improve clarity for applicants and regulators (e.g. environmental propertiesversus special precautions for the environmentand section on date of revision);
standard text for marketing authorisations granted for veterinary limited markets and under exceptional circ*mstances;
reference to national collection systems for disposal of waste veterinary medicines. This aims tohelp with correctdisposalof unused or waste veterinary medicines, to reflectlegal requirements under Regulation (EU) 2019/6;
guidance on specific content for novel therapies;
increased flexibility in some sections, e.g. possibility to express expiry date as dd/mm/yyyy for certain novel therapy and biological veterinary medicinal products;
consolidated section for all contact details.

EMA also simplified the SPC and package leaflet sectionson 'frequency and seriousness of adverse events', based on advice from the CVMP'sPharmacovigilance Working Party.

EMA'sWorking Group on Quality Review of Documents (QRD), the CVMP and the Coordination group for mutual recognition and decentralised procedures for veterinary medicinal products (CMDv)agreed the final template following a public consultation.

The template is available in all EU languages. EMA also made some editorial changes and corrections in the English version as well as all EU languages in November 2022.

QRD veterinary product-information annotated template (English) version 9.0

Reference Number: Version 9.0 Corr.2

English (EN) (563.34 KB - PDF)

First published: 16/07/2021Last updated: 14/11/2022

View

QRD veterinary product-information annotated template (English) version 9.0 highlighted

Reference Number: Version 9.0 Corr.

English (EN) (504.72 KB - PDF)

First published: 16/07/2021Last updated: 14/11/2022

View

QRD veterinary product-information highlighted template version 9.0

Reference Number: Version 9.0 corr.

English (EN) (277.35 KB - PDF)

First published: 14/11/2022

View

Other languages (25)

български (BG) (303.3 KB - PDF)

First published: 14/11/2022

View

español (ES) (282.05 KB - PDF)

First published: 14/11/2022

View

čeština (CS) (285.12 KB - PDF)

First published: 14/11/2022

View

dansk (DA) (276.34 KB - PDF)

First published: 14/11/2022

View

Deutsch (DE) (283.79 KB - PDF)

First published: 14/11/2022

View

eesti keel (ET) (271.31 KB - PDF)

First published: 14/11/2022

View

ελληνικά (EL) (308.5 KB - PDF)

First published: 14/11/2022

View

français (FR) (286.93 KB - PDF)

First published: 14/11/2022

View

hrvatski (HR) (285.03 KB - PDF)

First published: 14/11/2022

View

íslenska (IS) (265.32 KB - PDF)

First published: 14/11/2022

View

Gaeilge (GA) (284.24 KB - PDF)

First published: 14/11/2022

View

italiano (IT) (280.19 KB - PDF)

First published: 14/11/2022

View

latviešu valoda (LV) (276.32 KB - PDF)

First published: 14/11/2022

View

lietuvių kalba (LT) (287.02 KB - PDF)

First published: 14/11/2022

View

magyar (HU) (285.92 KB - PDF)

First published: 14/11/2022

View

Malti (MT) (347.26 KB - PDF)

First published: 14/11/2022

View

Nederlands (NL) (277.78 KB - PDF)

First published: 14/11/2022

View

norsk (NO) (276.47 KB - PDF)

First published: 14/11/2022

View

polski (PL) (292.18 KB - PDF)

First published: 14/11/2022

View

português (PT) (279.42 KB - PDF)

First published: 14/11/2022

View

română (RO) (279.75 KB - PDF)

First published: 14/11/2022

View

slovenčina (SK) (288.46 KB - PDF)

First published: 14/11/2022

View

slovenščina (SL) (280.72 KB - PDF)

First published: 14/11/2022

View

Suomi (FI) (272.34 KB - PDF)

First published: 14/11/2022

View

svenska (SV) (273.45 KB - PDF)

First published: 14/11/2022

View

QRD veterinary product-information template version 9.0

Reference Number: Version 9.0 Corr.

English (EN) (60.2 KB - DOCX)

First published: 16/07/2021Last updated: 14/11/2022

View

Other languages (25)

български (BG) (57.29 KB - DOCX)

First published: 16/07/2021Last updated: 14/11/2022

View

español (ES) (62.97 KB - DOCX)

First published: 16/07/2021Last updated: 14/11/2022

View

čeština (CS) (60.04 KB - DOCX)

First published: 16/07/2021Last updated: 14/11/2022

Previous template (v.8.2)

Applicants can continue to use template v.8.2 for presenting the product information in marketing authorisation applications and post-authorisation applications that were validated before 28 January 2022.

Atransition period was introducedbyRegulation (EU) 2022/839.

QRD template v.8.2 was revised in December 2021 to specify Northern Ireland in the list of local representatives at the end of the package leaflet.

QRD veterinary product-information template version 8.2

Reference Number: Version 8.2

English (EN) (176 KB - DOC)