New publication website for veterinary medicinal product information and new practice

As part of the migration of published medicinal product information from www.tierarzneimittel.ch to the new publication website www.swissmedicinfo-pro.ch, marketing authorisation holders will have to make the necessary changes to their veterinary medicinal product information (see list below) independently.

It has also emerged that the inclusion of the manufacturer responsible for batch release in the package leaflet does not provide any additional benefit. Swissmedic has therefore decided that this information will no longer be included in the package leaflet. Section heading 1 of the template for the package leaflet has been amended accordingly. Marketing authorisation holders will have to make the necessary changes to the package leaflet independently.

The following changes to the veterinary medicinal product information should be made independently (i.e. without submitting an application) at the next available opportunity:

Package leaflet: Changes in section 1, in the heading, and in section 14:

• Section 1: Deletion of the manufacturer responsible for batch release

Deadline: This change should be implemented at the next reprint, but at the latest when changes are made to the manufacturer or manufacturers responsible for batch release.

• Title: Reference to the Information for healthcare professionals. With effect from 27.08.2025 the Information for healthcare professionals for all authorised veterinary medicinal products will be published on the new publication website.

• Section 14: Reference to further information. Further information will be published on the Swissmedic website and, with effect from 27.08.2025, on the new publication website.

Deadline: These changes must be made within 5 years of the migration from www.tierarzneimittel.ch to the new publication website. After this deadline, the old link to www.tierarzneimittel.ch will no longer work.

Information for healthcare professionals and package leaflet: Obsolete section headings should be adapted to the current Swissmedic templates:

• To ensure that the medicinal product information (Information for healthcare professionals and/or package leaflet) can be uploaded to the new publication website, the marketing authorisation holders will have to adapt the section headings to the current templates independently.

As a rule, the current Swissmedic templates should always be used and the corresponding requirements observed (e.g. the fact that headings and their numbering may not be changed).

The marketing authorisation holders are responsible for ensuring that the above-mentioned changes are implemented correctly and on time. A corresponding application must be submitted for all other changes to the veterinary medicinal product information.