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.
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.
QRD template and SPC template
The Veterinary Medicinal Products Unit uses templates when it comes to adopting and approving product texts (SPC, label and package leaflet). These can be used during the national phase of an application, change to or extension of a marketing authorisation via the central, MRP, DCP and national procedure.
- Blank SPC-template – QRD 9.0 (Centralised)
- Blank SPC Template – QRD 9.0 (MRP/DCP/National)
- Blank SPC-Template – QRD 9.0 (combined labelling and package leaflet)
The templates above 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 and of the CMDv.
Conversion of existing SPCs, labels and package leaflets
The QRD template v. 9.0 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.
Please note: you will not be able to convert the SPC, labelling and package leaflet to QRD 9.0 during procedures still being dealt with in line with the old Directive 2001/82/EC. Information on conversion to QRD 9.0 can be found here: CMDv QA document on transitional arrangements.