The Human Medicines Regulations 2012 No. 1916

PART 13 U.K. Packaging and leaflets

CHAPTER 1 U.K.

Requirements for packaging and package leaflets relating to medicinal products U.K.

Packaging requirements: information for blind and partially sighted patients U.K.

259.—(1) The name of a medicinal product must also be expressed in Braille format on the outer packaging of the product (or, if there is no outer packaging, on the immediate packaging of the product).

(2) The holder of a [F1 UK marketing authorisation, EU marketing authorisation], Article 126a authorisation or traditional herbal registration for a medicinal product must ensure that the package leaflet is made available on request in formats suitable for blind and partially-sighted persons.

(3) Nothing in this regulation applies to a registrable homoeopathic medicinal product.

Textual Amendments

F1 Words in reg. 259(2) substituted (31.12.2020) by S.I. 2019/775, reg. 202 (as amended by The Human Medicines (Amendment etc.) (EU Exit) Regulations 2020 (S.I. 2020/1488), reg. 1, Sch. 2 para. 156)