In line with the European Regulation on Veterinary Medicinal Products (EU) 2019/6 marketing authorisation holders (MAHs) are required to update the product information (PI) of existing veterinary medicinal products before 29 January 2027.

The update is implemented by way of a G.I.18 VRA. This involves a one-off alignment of the PI with version 9 of the Quality Review of Documents (QRD) templates.
The timing of submission should ensure that the variation is finalised and implemented before 29 January 2027.

The document ‘Guidance on the submission of G.I.18 Variations Requiring Assessment’ should be read alongside the ‘QRD veterinary product-information annotated template (English) version 9’ and the CVMP/CMDv guidance document ‘Questions and answers on describing adverse events in the product information (summary of product characteristics (SPC) and package leaflet (PL))’ (EMA/CVMP/150343/2016).

MAHs should carefully review the principles within the document in order to ensure that the process of submitting and obtaining approval of a G.I.18 VRA is as efficient and as smooth as possible.

For national implementation, guidance on national-specific labelling/package leaflet information is available on the CMDv website.
However, MAHs are explicitly reminded that additional advice on national requirements for Germany (DE-BVL) is available on the BVL website (Advice on the use of the product information templates for veterinary medicines) and that this is to be followed respectively for the national PI.

Further Information:

CMDv:
Guidance on the submission of G.I.18 variations requiring assessment

Guidance on national-specific labelling/package leaflet information

EMA:
QRD veterinary product-information annotated template

Questions and answers on describing adverse events in the product information (summary of product characteristics (SPC) and package leaflet (PL)) (EMA/CVMP/150343/2016)

BVL:
Advice on the use of the product information templates for veterinary medicines - national requirements DE-BVL

Year of issue 2024
Date 13.06.2024

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