Specify the precise present and proposed wording or specification with reference to the MCA CTD number(s), where applicable For SmPC, container labelling and patient information leaflet changes, underline or highlight the changed words presented in the table below or provide as a separate Annex. PRESENT PROPOSED CTD Section
Specify the precise present and proposed wording or specification with reference to the MCA CTD number(s), where applicable For SmPC, container labelling and patient information leaflet changes, underline or highlight the changed words presented in the table below or provide as a separate Annex. PRESENT PROPOSED CTD Section