Product-information templates

This page lists the templates for product information for use by applicants and marketing-authorisation holders of veterinary medicines. The European Medicines Agency'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 such requirements.

Veterinary product information templates

The QRD group, the Coordination Group for Mutual Recognition and Decentralised Procedures - Veterinary (CMDv) and the Committee for Medicinal Products for Veterinary Use (CVMP) revised the veterinary product information templates in February 2017. This revision builds on 4 years of experience with the previous version 8.

The QRD group also implemented editorial improvements in the translations.

EMA published an implementation plan for the centralised procedure and the CMDv published an implementation plan for the decentrealised, the mutual recognition and national procedures on their respective websites.

The revised templates are available on both the EMA and CMDv websites.

Maltese fonts

Maltese fonts are built in to Windows XP SP3 and higher.

Centralised procedures

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