Regulation 125A List of approved countries for traditional use of a herbal medicinal productF1

(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.

Annotations

Textual amendments

F1: Reg. 125A inserted (31.12.2020) by The Human Medicines (Amendment etc.) (EU Exit) Regulations 2019 (S.I. 2019/775), regs. 1, 111; 2020 c. 1, Sch. 5 para. 1(1)

Notes on Interpretation and application of Part

Textual amendments

F1: Pt. 7 cross-heading substituted (31.12.2020) by The Human Medicines (Amendment etc.) (EU Exit) Regulations 2019 (S.I. 2019/775), regs. 1, 108; 2020 c. 1, Sch. 5 para. 1(1)