Based on the latest revision of the Therapeutic Products Act and the Therapeutic Products Ordinances, the structure of the Swiss product information for all veterinary medicines is being harmonised with that in the EU.[1] The first product information texts for veterinary medicines with the new structure have now been published. The harmonisation of texts for all authorised veterinary medicines is scheduled for completion by the end of 2024. Swissmedic had published information on this subject on 25 October 2018 and 8 November 2019. [2] In parallel with the harmonisation of medicinal product information, the dispensing categories will also be reviewed for prescription-only veterinary medicines. [3]
The following innovations will be implemented with the revision:
- Two-part medicinal product information, consisting of Information for healthcare professionals and a package leaflet in language understood by lay people. This particularly applies to medicines for pets in dispensing category B, which are administered by the animal owners themselves. The “Information for healthcare professionals” is intended for veterinarians and, in these cases, is available exclusively online in the Compendium of veterinary medicines. [4]
- The content of the package leaflet may differ from that of the “Information for healthcare professionals” as it has to be comprehensible to a lay readership. Thus the package leaflet for veterinary medicines with two-part product information contains the statement "Information for animal owners; for the 'Information for healthcare professionals’, see www.tierarzneimittel.ch".
- Certain veterinary medicinal products only require one-part product information (either only the 'Information for healthcare professionals’ or only a package leaflet easily understood by lay people), which is enclosed in the packaging of the veterinary medicine and is also available online in the Compendium of veterinary medicines.
- Full declaration: The quantities of all active substances and excipients of particular interest (particularly preservatives and antioxidants) will continue to be declared. All other excipients will also now be listed. [5]
- Structured breakdown of clinical and preclinical information.
- Additional information in separate sections on Overdose, Pregnancy, Interactions, User safety or Environmental compatibility in order to promote the safe and correct use of the veterinary medicine.
- Product information in 3 languages: German, French and Italian. If, for technical reasons, the marketing authorisation holder is unable to provide trilingual “Information for healthcare professionals” in the packaging, the Italian version should nevertheless be available in the Compendium of veterinary medicines. [6]
The aim of this revised medicinal product information is to provide veterinarians and animal owners with an improved, more targeted and EU-harmonised overview of the key aspects concerning the safe and effective use of veterinary medicines.
Swissmedic attaches particular importance to the comprehensibility by lay people of the package leaflets for pet medicines in order to help the animal owners use them correctly. This is designed to serve as an effective addition to the veterinarian's advice when using veterinary medicines.