Information specific to the pharmacological group to which the medicinal product for which the RMP is being developed belongs may be reflected in sections CVII.1 – CVII.5.2 of Part II of the RMP.
If properties characteristic of the pharmacological group of the medicinal product were not detected during the preclinical, clinical pre-registration and post-registration study of the medicinal product, they may be reflected in section CVII.5.2 of part II of the SmPC.
