The guidance document Product information for human medicinal products HMV4 provides applicants with clear information on the requirements that must be fulfilled so that product information texts can be processed as quickly and efficiently as possible.
Swissmedic has updated the content of the guidance document, e.g. relating to vulnerable populations or boxed warnings, on the basis of the experience gained, in particular with the new requirements under the revised Therapeutic Products Act.
Other changes have been made in line with international practice, e.g. in the section on pregnancy/breastfeeding.
Some linguistic and content-related clarifications have also been made. These reflect the current Swissmedic practice and are therefore not new requirements. Certain requirements have also been formulated which have previously been handled in different ways in practice, and are to be applied consistently in future.
Please see the guidance document for details.
The guidance document comes into force on 1 June 2020 and applies to all new applications with immediate effect.
For ongoing new applications, the requirements of the revised guidance document must be followed as long as the LoQ milestone has not yet been reached as of 1 June 2020.
For medicinal products that have already been authorised, the revised guidance document must be observed for future applications for variations of product information texts in the relevant sections. These do not have to be fully revised and neither is this expected. Therefore, no applications should be sent to Swissmedic based solely on the updates to the guidance document.