To be able to support the new veterinary regulations coming into effect in January 2022, the EMA updated the product information template that can be accessed here . The new template includes a new section on restrictions on the use of antimicrobials and antiparasitic veterinary products in an attempt to reduce resistance.
The other thing to notice is that the new template will address the need for Marketing Authorisation Holders (MAHs) to address any environmental issues. One notable example is the need to include information on special precautions for the protection of the environment – this information will help users of the medicinal product to better defend the environment.
What are the timelines?
One of the main aspects of the new template is that it supports the requirements under Regulation (EU) 2019/6, coming into effect 28/January/2022. Therefore, template version v9.0 should be used for all initial marketing applications after 28/January/2022. For product information of medicinal products placed on the market in accordance with Regulation (EC) 726/2004, template v8.2 may be used until 29/January/2027.
Please note that QRD template v.8.2 was revised in December 2021 to specify Northern Ireland as a local representative.
What does the new template v9.0 contain?
• a new structure of the SPC labelling and package leaflet with the order of sections aligned as far as possible;
• information only to be included in the package leaflet that was formerly in the labelling, simplifying the outer and immediate labelling;
• a consolidated section on ‘minimum particulars to appear on small immediate packaging units’ which now incorporates blisters and strips;
• a new section on any restrictions on the use of antimicrobial and antiparasitic veterinary products. This includes restrictions on conditions of use that are not in accordance with the terms of the marketing authorisation (MA);
• expanded guidance text in many sections to improve clarity for applicants and regulators;
• standard text for “marketing authorisation” granted for veterinary limited markets and under exceptional circumstances;
• reference to national collection systems for disposal of waste veterinary medicines.;
• guidance on specific content for novel therapies;
• increased flexibility in some sections;
• consolidated section for all contact details.
EMA also simplified the SPC and package leaflet sections on ‘frequency and seriousness of adverse events’.
It is clear that a big effort has been made to align the QRD template with the NVR coming into effect in January 2022. Although we can expect finalisation of the combined label-leaflet QRD in the fourth quarter of 2021, companies can already align their data and processes with the new template v9.0.