When a marketing authorisation is issued, a Summary of Product Characteristics (SPC), label and package leaflet are set. The SPC, the label and the package leaflet must satisfy various requirements. These are set out in standard templates.
The requirements for the SPC, label and package leaflet differ. In terms of the label requirements, a distinction is made between different forms of packaging. The outer packaging is the packaging that contains the main packaging. The main packaging is the packaging in direct contact with the veterinary medicinal product. The package leaflet is the leaflet providing information for the user. This is enclosed in the outer packaging along with the veterinary medicinal product. It is also possible that all information that needs to be in the package leaflet is stated directly on the main packaging. This is called a combined label-package insert.
The requirements for the SPC, label and package leaflet pertain to such matters as promoting a veterinary medicinal product. For instance, it is prohibited for the packaging or package leaflet for a veterinary medicinal product to feature a website – or email address indicating a website – belonging to the holder of the marketing authorisation for the veterinary medicinal product. Exceptions are only possible with express permission. To this end, you will have to demonstrate to the Veterinary Medicinal Products Unit the necessity and utility of featuring this information for proper usage of the veterinary medicinal product in line with the product information. For more information on the use of QR codes, please consult our Q&A document.
QRD template and SPC template
The Veterinary Medicinal Products Unit uses European templates when it comes to adopting and approving product texts (SPC, label and package leaflet).
These templates were drawn up by the European Medicines Agency’s Working Group on Quality Review of Documents (QRD). The templates have been harmonised across European Member States. The QRD group comprises members of the CMDv and the Committee for Medicinal Products for Veterinary Use (CVMP).
The English-language and Dutch-language QRD templates can be found on the websites of the EMA.
Dutch versions of these templates can be used during the national phase of an application, amendment or granting of a marketing authorisation via the central, MRP, DCP and national procedures.
Conversion of existing SPCs, labels and package leaflets
The QRD template v.9 is mandatory for all applications validated on or after 28 January 2022. What is more, you will need to have converted all existing SPCs, labels and package leaflets to this new version by 29 January 2027 by means of a one-off change accompanied by an assessment.
Information on conversion to QRD 9.0 can be found here: CMDv QA document on transitional arrangements.
