Paragraph 18
Bibliographical or expert evidence of the traditional use of the medicinal product or a product corresponding to the medicinal product.
For this purpose a product (“A”) corresponds to a medicinal product (“B”) if—
(a)
product A has the same active ingredients as product B (regardless of the excipients used in either product);
(b)
product A's intended purpose is the same as or similar to product B's intended purpose;
(c)
product A has a strength and dosage equivalent to that of product B; and
(d)
product A's route of administration is the same as or similar to product B's route of administration.