Action required: The EMA invites comments for the new product information template by 14/May/2021.

The EMA just released a new product information template for public consultation. Besides smaller adjustments, the template mainly addresses changes required in line with the New Veterinary Regulations (NVR) that is coming into effect January 2022. Although no firm date for implementation has been provided for the new template, the EMA will inform Marketing Authorisation Holders (MAHs) when to start using the new template after the NVR comes into force.

What does the new template contain?

The new template contains the following:

• a new structure of the SPC and package leaflet; MAHs have to adjust their own templates accordingly to stay compliant;
• Simplification of outer and immediate labelling by providing information only in the package leaflet;
• a consolidated section on ‘minimum particulars to appear on small immediate packaging units’;
• a new section on any restrictions on the use of antimicrobial and antiparasitic veterinary medicines;
• standard text for marketing authorisations 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.

The EMA also simplified the SPC and package leaflet sections on frequency and seriousness of adverse events.

Changes to be considered by Marketing Authorisation Holders (MAHs)

The main purpose of the new template is to be compliant with the NVR and hence it is now based on “Article 35 of Regulation (EU) 2019/6” instead of “Article 14 of Directive 2001/82/EC”.

Another update MAHs will notice is the link to EMA’s SPOR, or better to the Referentials of SPOR. Here MAHs can already benefit from solutions such as Samarind RMS, providing an interface to SPOR and therefore minimising list management and eliminate data entry mistakes. The EMA changed template references accordingly from “Target species: according to the target species CTL on the EUTCT website” to “Target species: according to the target species list under “Referentials” on the SPOR website.

MAHs that are more focused on regional markets will also notice the addition of the national procedure.

More subtle changes are for specific field formats such as the expiry date, changing from “EXP {month/year}” now to “Expiry dates should be expressed with the month given as 2 digits and the year as 4 digits. e.g.02/2007”. Another example is the manufacturing batch number, which previously was given as “<Batch> <Lot> <BN> {number}”, now defined in a new format as “Lot {number}”.

In summary

Although some changes are more subtle with only minor impact on the actual content of the veterinary product information template, MAHs still need to address any alterations to stay compliant. This of course brings further demands on MAHs in the veterinary space. With the deadline of the NVR looming in January 2022, and a deadline for comments on the veterinary product information template coming up imminently, MAHs do not have much time to get involved. However, SPOR Referentials should help to simplify reference data management significantly.

Published by Olaf Schoepke

Passionate about sharing ideas with regulatory professionals in the human and veterinary medicinal product space.

%d bloggers like this: