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

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

Reference Number: EMA/785529/2017 Rev.1

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

Reference Number: EMA/364980/2017_rev. 2

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...

Reference Number: EMA/818103/2017, rev. 1

List of official languages per country

Reference Number: EMA/315185/2010 Rev.4

Abbreviation of names of days on calendarised blisters

Reference Number: EMA/188814/2012 Rev.2

Tables of non-standard abbreviations to be used in the summary of product characteristics

Reference Number: EMA/27236/2003 Rev. 15

Compilation of quality review of documents (QRD) on stylistic matters in product information

Reference Number: EMA/25090/2002 Rev. 23

Compilation of Quality Review of Documents decisions on the use of terms

Names of the European Union / European Economic Area countries

Reference Number: EMA/123695/2004 Rev.14

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

Adopted Reference Number: EMA/62470/2007 Legal effective date: 01/06/2007

QRD guidance on the use of adopted abbreviations and pictograms on the packaging of veterinary medicinal products authorised via the centralised (CP), mutual recognition (MRP), decentralised (DCP), subsequent recognition (SRP) and national procedures

Adopted Reference Number: EMA/776723/2017 Rev.3

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

Adopted Reference Number: EMA/CVMP/383441/2005-Rev.1 Corr1 Legal effective date: 28/01/2022 Summary:

This guideline replaces the current CVMP guideline on the SPC for antimicrobial products (EMEA/CVMP/SAGAM/383441/2005) and the Question 2 of the question & answer document (EMA/CVMP/414812/2011-Rev.2).

Question and answer on the information contained within section 5.1 of the summary of product characteristics on pharmacodynamic properties for pharmaceutical products

Reference Number: EMA/CVMP/757903/2016 Summary:

This question and answer was developed to aid the writing or update of section 5.1 of the summary of product characteristics (SPC).

Questions and answers on mentioning solvents in the product information of veterinary medicinal products authorised via the centralised procedure

Adopted Consultation dates: 18/12/2015 to 31/03/2016 Reference Number: EMA/CVMP/550607/2015 Summary:

This general guidance, in the form of a question and answer document, is intended to clarify how the product information (Summary of Product Characteristics (SPC), labelling and package leaflet) should be prepared for products which require solvents for their administration.

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

Reference Number: EMA/CVMP/150343/2016-Rev.4

Concept paper on revision of the current guideline on the summary of product characteristics for antimicrobial products

Draft: consultation closed Consultation dates: 25/07/2016 to 31/10/2016 Reference Number: EMA/CVMP/AWP/161553/2016 Summary:

The current guideline on the summary of product characteristics (SPC) for antimicrobial products was developed during 2001-2002 by the EWP and came into effect on 11 June 2003. The guideline was revised by SAGAM (now AWP) during 2006 and 2007 and the revised guideline came into effect on 1 May 2008 (EMEA/CVMP/SAGAM/383441/2005)(1). Since then there have been further significant developments in principles of antimicrobial therapy and antimicrobial resistance and various initiatives have been taken by CVMP.

Concept paper for the revision of the guideline on the summary of product characteristics for anthelmintics

Draft: consultation closed Consultation dates: 15/12/2017 to 31/03/2018 Reference Number: EMA/CVMP/EWP/158889/2017 Summary:

The current guideline on the Summary of Product Characteristics (SPC) for anthelmintics (EMEA/CVMP/EWP/170208/2005) recommends standard warnings aimed at delaying the development of anthelmintic resistance. The scope of the guideline is currently limited to products for sheep, goats, cattle and horses, and proposes standard text for sections 4.4 and 4.9 of the SPC. The scope of the guideline should be extended to host species other than ruminants and horses, e.g. to pigs and companion animals. In those additional species, resistance emergence is reported in some helminths in given geographical areas.

Concept paper on the need for revision of the position paper on indications for veterinary vaccines

Draft: consultation closed Consultation dates: 13/10/2011 to 31/12/2011 Reference Number: EMA/CVMP/IWP/785621/2011 Summary:

The proposed guideline will replace the CVMP revised position paper on indications for veterinary vaccines (EMEA/CVMP/042/97-Rev.1-FINAL)

Revised position paper on indications for veterinary vaccines

Adopted Reference Number: EMEA/CVMP/042/97-Rev.1-FINAL

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...

Reference Number: EMEA/CVMP/123846/2006-CONSULTATION

Guideline on the summary of product characteristics for antiparasitic veterinary medicinal products - Revision 1

Adopted Reference Number: EMA/CVMP/EWP/170208/2005 Rev.1 Corr1 Legal effective date: 01/07/2022

Concept paper on the need to elaborate summary-of-product-characteristics guidance to minimise the development of anthelmintic resistance

Reference Number: EMEA/CVMP/638/04-FINAL

Question and answer on the CVMP guideline on the summary of product characteristics for antimicrobial products

Reference Number: EMA/CVMP/414812/2011 Rev.2

Reflection paper on the use of fluoroquinolones in food-producing animals - precautions for use in the summary of product characteristics regarding prudent-use guidance

Reference Number: EMEA/CVMP/416168/2006-FINAL

• 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