# The Human Medicines Regulations 2012, 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.

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Source: https://www.legislation.gov.uk/uksi/2012/1916/schedule/12/paragraph/18 (the official version)
Page: https://openlegislation.uk/human-medicines-regulations-2012/schedule-12/paragraph-18
Contains public sector information licensed under the Open Government Licence v3.0. Source: legislation.gov.uk, The National Archives.