Product information: Reference documents and guidelines

This page lists the reference documents and guidelines on the quality of product information for centrally authorised veterinary medicines, including style, terminology, use of abbreviations and the translations of standard terms into European Union (EU) languages.

Reference documents

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Member states contact points for review of national translations of Quick Response (QR) codes of veterinary medicinal products authorised via the centralised, mutual recognition, decentralised procedures and national procedures (PDF/162.89 KB)

First published: 09/02/2018
Last updated: 05/01/2023
EMA/785529/2017 Rev.1
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Quick Response (QR) codes in the labelling and/or package leaflet of veterinary medicinal products authorised via the centralised (CP), mutual recognition (MRP), decentralised procedures (DCP) and national procedures (PDF/162.54 KB)

First published: 09/02/2018
Last updated: 15/03/2018
EMA/364980/2017
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Request form for the provision of information via Quick Response (QR) codes in the labelling and/or package leaflet of veterinary medicinal products authorised via the centralised (CP), mutual recognition (MRP), decentra... (DOCX/124.85 KB)

First published: 09/02/2018
Last updated: 09/02/2018
EMA/818103/2017
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List of official languages per country (PDF/124.9 KB)

First published: 04/04/2012
Last updated: 31/12/2020
EMA/315185/2010 Rev.3
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Abbreviation of names of days on calendarised blisters (PDF/194.95 KB)

First published: 04/04/2012
Last updated: 31/12/2020
EMA/188814/2012
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Tables of non-standard abbreviations to be used in the summary of product characteristics (PDF/268.34 KB)

First published: 01/04/2009
Last updated: 08/12/2021
EMA/27236/2003 Rev. 14
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Compilation of quality review of documents (QRD) on stylistic matters in product information (PDF/410.74 KB)

First published: 01/02/2008
Last updated: 09/06/2022
EMA/25090/2002 Rev. 22
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Compilation of Quality Review of Documents decisions on the use of terms (PDF/152.97 KB)

First published: 01/12/2005
Last updated: 28/03/2011
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Names of the European Union / European Economic Area countries (PDF/286.77 KB)

First published: 23/07/2008
Last updated: 08/12/2021
EMA/123695/2004 Rev.13
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Quality Review of Documents (QRD) convention to be followed for the European Medicines Agency QRD templates (PDF/92.33 KB)

Adopted

First published: 01/06/2007
Last updated: 15/04/2011
Legal effective date: 01/06/2007
EMA/62470/2007
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Quality review of documents (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) (PDF/287.7 KB)

Adopted

First published: 25/11/2016
Last updated: 31/05/2021
EMA/776723/2017 Rev.2

Committee for Medicinal Products for Veterinary Use (CVMP) scientific guidelines

Guidance on national-specific labelling/package leaflet information
Office for Official Publication of the European Communities
EudraLex website
- Volume 4: Good manufacturing practice (GMP) guidelines.
- Volume 5: Pharmaceutical legislation: Medicinal products for veterinary use
- Volume 6A: Procedure for marketing authorisation
- Volume 6B: Presentation and content of the dossier
- Volume 6C: Regulatory guidelines
- Volume 7A: General, efficacy, environmental risk assessment
- Volume 7B: Immunologicals, quality
- Volume 8: Maximum residue limit (MRL) guidelines
- Volume 9: Pharmacovigilance guidelines

Product information: Reference documents and guidelines

Table of contents

Reference documents

Member states contact points for review of national translations of Quick Response (QR) codes of veterinary medicinal products authorised via the centralised, mutual recognition, decentralised procedures and national procedures (PDF/162.89 KB)

Quick Response (QR) codes in the labelling and/or package leaflet of veterinary medicinal products authorised via the centralised (CP), mutual recognition (MRP), decentralised procedures (DCP) and national procedures (PDF/162.54 KB)

Request form for the provision of information via Quick Response (QR) codes in the labelling and/or package leaflet of veterinary medicinal products authorised via the centralised (CP), mutual recognition (MRP), decentra... (DOCX/124.85 KB)

List of official languages per country (PDF/124.9 KB)

Abbreviation of names of days on calendarised blisters (PDF/194.95 KB)

Tables of non-standard abbreviations to be used in the summary of product characteristics (PDF/268.34 KB)

Compilation of quality review of documents (QRD) on stylistic matters in product information (PDF/410.74 KB)

Compilation of Quality Review of Documents decisions on the use of terms (PDF/152.97 KB)

Names of the European Union / European Economic Area countries (PDF/286.77 KB)

Quality Review of Documents (QRD) convention to be followed for the European Medicines Agency QRD templates (PDF/92.33 KB)

Quality review of documents (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) (PDF/287.7 KB)

Committee for Medicinal Products for Veterinary Use (CVMP) scientific guidelines

Guideline on the summary of product characteristics (SPC) for veterinary medicinal products containing antimicrobial substances - Revision 1 (PDF/311.71 KB)

Question and answer on the information contained within section 5.1 of the summary of product characteristics on pharmacodynamic properties for pharmaceutical products (PDF/71.45 KB)

Questions and answers on mentioning solvents in the product information of veterinary medicinal products authorised via the centralised procedure (PDF/111.16 KB)

Questions and answers on describing adverse events in the product information (summary of product characteristics (SPC) and package leaflet (PL)) (PDF/176.36 KB)

Concept paper on revision of the current guideline on the summary of product characteristics for antimicrobial products (PDF/118.27 KB)

Concept paper for the revision of the guideline on the summary of product characteristics for anthelmintics (PDF/146.37 KB)

Concept paper on the need for revision of the position paper on indications for veterinary vaccines (PDF/71.27 KB)

Revised position paper on indications for veterinary vaccines (PDF/108.98 KB)

Concept paper on concurrent administration of immunological veterinary medicinal products in view of determining day X to be 14 days and consequent revision of the summary-of-product-characteristics guideline for immunol... (PDF/38.08 KB)

Guideline on the summary of product characteristics for anthelmintics - First version (PDF/96.56 KB)

Concept paper on the need to elaborate summary-of-product-characteristics guidance to minimise the development of anthelmintic resistance (PDF/44.65 KB)

Question and answer on the CVMP guideline on the summary of product characteristics for antimicrobial products (PDF/92.41 KB)

Reflection paper on the use of fluoroquinolones in food-producing animals - precautions for use in the summary of product characteristics regarding prudent-use guidance (PDF/50.6 KB)

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