Changes to the Guidance document Product information for human medicinal products

Swissmedic specifies the requirements for the presentation of undesirable effects and interactions and adds information on environmental and disposal aspects.

Swissmedic has thoroughly revised the Undesirable effects section. In particular, the procedure for pooling the safety data has been clarified. The guidance document now also specifies a tabular format for listing the frequencies of undesirable effects.

The level of detail concerning the requirements has been reduced in the Interactions section. The focus is now on clinically relevant information. Only the ratios of the pharmacokinetic parameters are now required for in vivo studies; negative in vivo or in vitro data should only be described briefly. Tabular formats are now envisaged only for complex situations. Relevant in silico data can now also be used to describe the interaction potential. Moreover, drug interactions, if applicable, are also to be listed as contraindications in the Information for healthcare professionals.

The general requirements for preparing the Information for healthcare professionals have now been combined in an introductory section, in which Swissmedic also maintains its long-standing practice whereby different pharmaceutical forms may be presented in a collective text only if this combined presentation does not give rise to any safety concerns (such as possible use errors).

To protect the environment, a reference to ecotoxicological investigations for medicinal products with corresponding potential has now been included in the Preclinical data section. In addition, the guidance document now provides instructions on proper disposal in the Other information section. These can optionally be included in the Information for healthcare professionals. In the Patient information, the recently added Disposal instructions have been expanded and adapted accordingly.

For oncologicals with genotoxic potential, a reference has been added stating that the Swiss requirements are based on the guidance document published by the FDA on the assessment of the risk of reproductive toxicity.

The Clinical efficacy section has been supplemented by information on immunogenicity, particularly on the effects of anti-drug antibodies on the efficacy of the medicinal product.

Various editorial changes have also been made as part of the update.

The revised Guidance document Product information for human medicinal products applies to newly created product information texts with effect from 1 March 2026. For new applications that are already in progress, the applicants can voluntarily take the revised guidance document into account. This must be explicitly stated in the cover letter and may, in individual cases, prolong the procedure. For medicinal products that are already authorised, in justified cases it will be decided, within the context of variation applications, whether a revision of the product information in the relevant sections is appropriate. Applications do not need to be submitted to Swissmedic solely as a result of updates to the guidance document.