Veterinary product information (QRD) templates

The European Medicines Agency's (EMA) provides templates 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 marketing authorisations that have not yet undergone the variation requiring assessment of classification G.I.18 to align with QRD v.9
• Template v.9.1 for initial marketing authorisation applications validated on or after 10 March 2025
• Combined label-leaflet v.9.1 template for initial marketing authorisation applications validated on or after 10 March 2025 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.9.1)

Product information template v.9.1 supports the requirements of the Veterinary Medicinal Products Regulation (Regulation (EU) 2019/6), which applies from 28 January 2022, as well as the requirements of the Regulation for veterinary medicinal products for oral administration (Regulation (EU) 2024/1159), the Regulation adopting a list of abbreviations and pictograms (Regulation (EU) 2024/875) and the Regulation adopting uniform rules on the size of small immediate packaging (Regulation (EU) 2024/878).

Template v.9.1 contains:

• new standard statements and guidance text in accordance with the product information requirements for products for oral administration (e.g. SPC sections 3.8 on interactions and 3.9 on administration routes and dosage);
• new guidance text in the labelling and the package leaflet regarding the approved pictograms and abbreviations to be used on the packaging and on the size of small immediate packaging;
• expanded guidance text in several sections to improve clarity for applicants and regulators (e.g. contraindications, special precautions for use, adverse events, date of last revision, contact details), which are applicable at the time of aligning the product information with QRD template v.9.1 according to the QRD implementation plan mentioned below. NB the change to the principle for the date of last revision is applicable from this point on to any version of the QRD template;
• expanded standard statements for marketing authorisations granted for limited markets and in exceptional circumstances (to align with the guidance to applicants);
• a new standard statement regarding pharmacovigilance requirements in Annex II for centrally authorised veterinary medicinal products containing new active substances;
• a revised list of CVMP and CMDv guidance.

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

For more details on how to align the product information with QRD template v.9.1, applicants and marketing authorisation holders are advised to consult the QRD implementation plan.

The template is available in all EU languages.

QRD veterinary product-information annotated template (English) version 9.1

QRD veterinary product-information annotated template (English) version 9.1 highlighted

QRD veterinary product-information highlighted template version 9.1

QRD veterinary product-information template version 9.1

QRD veterinary v.9.1 – Implementation plan

Reference Number: EMA/472382/2024

Previous template (v.8.2)

Marketing authorisation holders can continue to use template v.8.2 for presenting the product information in post-authorisation applications for veterinary medicinal products which have been authorised before 28 January 2022 and whose product information has not been updated to QRD v.9 yet.

A transition period was introduced by Regulation (EU) 2022/839.

QRD veterinary product-information template version 8.2

Reference Number: Version 8.2

QRD veterinary product-information annotated template (English) version 8.2

QRD veterinary annex A template

Marketing authorisation holders should update and implement their product information, in accordance with QRD template v.9.1 respectively by 29 January 2027, taking into account the implementation plan included above.

They should do so by submitting a variation requiring assessment of classification G.I.18, in line with the CMDv / EMA guidance listed below:

Guidance on the details of the classification of variations requiring assessment according to Article 62 of Regulation (EU) 2019/6 for veterinary medicinal products and on the documentation to be submitted pursuant to those variations

AdoptedReference Number: EMA/CMDv/7381/2021 Rev.4 Corr.

QRD combined label-leaflet template (v.9.1)

QRD veterinary combined label-leaflet template v.9.1

QRD veterinary combined label-leaflet annotated template (English) v.9.1

Appendices

QRD veterinary Appendix I - Adverse event (PhV) MSs reporting details

Reference Number: EMA/217477/2022, version 4