Regulation 9 and 10 of the Medicines and Related Substances Act, 1965 (Act 101 of 1965) requires that each package of a medicine shall have a Package Insert (PI) and Patient Information Leaflet (PIL) and prescribes the information that must be contained therein.
Regulation 10 also requires that a person dispensing or administering a medicine must ensure that a PIL is made available at the point of such dispensing or administration.
Professional Information for Medicines for Human Use
9(1) Subject to sub regulation (4),professional information shall be made available -
For each medicine –
In hard copy either separately or as an integral part of the package; or electronically