SPC, labelling and package leaflet veterinary medicinal products

When a marketing authorisation is granted, a Summary of Product Characteristics (SPC), a label and a package leaflet will be established. The SPC, the label and the package leaflet must meet various requirements. These requirements have been translated into standard templates.

The requirements for the SPC are different to those for the label and the package leaflet. In the case of the requirements for the label an additional distinction is made between the various packaging forms. The outer packaging is the packaging in which the primary packaging is placed. The primary packaging is the packaging which comes into direct contact with the veterinary medicinal product. The package leaflet is the information sheet for the user that accompanies the veterinary medicinal product in conjunction with the primary packaging in the outer packaging.

The requirements with regard to the SPC, the label and the package leaflet relate to, among other things, the advertising of a veterinary medicinal product. For example it is not permitted, pursuant to European agreements about SPC, label and package leaflet texts, to refer on the packaging or package leaflet of a veterinary medicinal product to a website - or an email address which links to a website - of the holder of a market authorisation of a veterinary medicinal product. An exception to this can only be made if the Veterinary Medicinal Products Unit demonstrates the usefulness and necessity of doing so for the proper use of the veterinary medicinal product in accordance with the product information.

QRD-template and SPC-template

The following templates are used by the VMPU when establishing and approving product texts (SPC, label and package leaflet) during the national phase of an application, amendment or granting of a marketing authorisation via the centralised, MRP, DCP and national procedure.

The above-mentioned templates were drawn up by the EMA's Working Group on Quality Review of Documents (QRD) and harmonised between the European Member States. This QRD group consists of members from the Veterinary Coordination Group for Mutual Recognition (MRP) and Decentralised Procedures (DCP), or in other words the CMDv and the Committee for Medicinal Products for Veterinary Use (CVMP).

QRD templates in English and Dutch can be found on the websites of the EMA and CMDv.