# The Human Medicines (Amendment etc.) (EU Exit) Regulations 2019, Regulation 111: Insertion of regulation 125A (list of approved countries for herbal medicinal products)


After regulation 125 insert—
“List of approved countries for traditional use of a herbal medicinal product
125A. (1) The licensing authority may publish a list of countries for the purposes of regulation 125(5)(b) (condition D).
(2) In establishing the list under paragraph (1), the licensing authority may only include a country in that list if it is satisfied that—
(a) continuous use evidence in respect of that country can be sufficiently validated by the licensing authority; and
(b) the country has a level of pharmacovigilance that is equivalent to that in the United Kingdom to ensure that any safety issues in respect of the herbal medicinal product have been properly identified.
(3) The licensing authority must—
(a) review any list it publishes under paragraph (1) to determine if a country still satisfies the criteria for inclusion in the list specified in paragraph (2), and if it is not so satisfied, remove that country from the list; and
(b) undertake such a review at least every three years beginning with the date on which the country is included in that list.”.

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Source: https://www.legislation.gov.uk/ukdsi/2019/9780111179185/regulation/111 (the official version)
Page: https://openlegislation.uk/draft-human-medicines-amendment-etc-eu-exit-regulations-2019/regulation-111
Contains public sector information licensed under the Open Government Licence v3.0. Source: legislation.gov.uk, The National Archives.