A number of clarifications have been made in the new minor version of the Guidance document Product information for human medicinal products HMV4. The requirements regarding boxed warnings are set out in a new annex. Information for healthcare professionals that is intended solely for use in hospitals can be in an official language or English. In addition, it has been clarified when warnings concerning pregnancy and lactation should also be included in the “Warnings” section.
Some wording has also been changed, e.g. paediatric population, to reflect the current Swissmedic practice and should be used consistently in future.
The new minor version 3.2 of the guidance document takes effect on 1 July 2022.
The detailed information for healthcare professionals template