Adaptation of formal requirements for marking/highlighting changes in manuscripts of medicinal product information (information for healthcare professionals and patient information)
Swissmedic has been processing medicinal product information texts (manuscripts of information for healthcare professionals and patient information) entirely electronically using Word’s “Track Changes” function since 13 April 2015.
To ensure efficient working, it is essential that applicants also mark or highlight changes using Word’s “Track Changes” function.
Consequently, other types of marking or highlighting in manuscripts of information for healthcare professionals and patient information (e.g. coloured type, struck through text, or coloured background highlighting) will not be accepted as of 1 January 2017 and will result in the issuing of a formal complaint.
Points A.126.96.36.199 “Marking of changes” and A.188.8.131.52 “Composition of the medicinal product information for medicinal products with known active pharmaceutical ingredients (without innovation) and biosimilars” of Section 2.5.3 “Medicinal product information” in the guidance document Formal requirements have been adapted accordingly.
The new requirements for manuscript presentation apply to all new submissions made to Swissmedic as of 1 January 2017.
Pending submissions and submissions made before 1 January 2017 are not affected and will continue to be formally reviewed according to the old requirements.