SCHEDULES

SCHEDULE 12Material to accompany an application for a traditional herbal registration

PART 2Summary of the product characteristics

26.

Pharmaceutical particulars of the medicinal product, covering—

(a)

a list of excipients;

(b)

major incompatibilities;

(c)

shelf life after reconstitution of the medicinal product or when the immediate packaging is opened for the first time (as appropriate);

(d)

special precautions for storage;

(e)

nature and contents of the container; and

(f)

special precautions for disposal of the used medicinal product or waste materials derived from the medicinal product (as appropriate).