overdose and special situation in clinical trial protocol

During the development of a clinical trial protocol, when should [COLOR=#000000][FONT=ui-sans-serif]overdose[/FONT][/COLOR] and [COLOR=#000000][FONT=ui-sans-serif]special situation[/FONT][/COLOR] be included in the [COLOR=#000000][FONT=ui-sans-serif]safety reporting[/FONT][/COLOR] section?[COLOR=#000000][FONT=ui-sans-serif][/FONT][/COLOR]
Are the overdose and special situation reporting requirements applicable only to [COLOR=#000000][FONT=ui-sans-serif]marketed products which is a investigational medicinal product[/FONT][/COLOR], or are they also required for [COLOR=#000000][FONT=ui-sans-serif]investigational medicinal products never marketed[/FONT][/COLOR]?[COLOR=#000000][FONT=ui-sans-serif][/FONT][/COLOR]
For unmarketed investigational [COLOR=#000000][FONT=ui-sans-serif]medicinal[/FONT][/COLOR][COLOR=#000000][FONT=ui-sans-serif] [/FONT][/COLOR]products, is it acceptable [COLOR=#000000][FONT=ui-sans-serif]not[/FONT][/COLOR] to include the reporting requirements for them in the protocol?