# The Human Medicines Regulations 2012, Regulation 260: Package leaflets


(1) A package leaflet for a medicinal product must—
(a) be drawn up in accordance with the summary of the product characteristics; and
(b) contain all the information specified in Schedule 27 in the order specified in that Schedule.
(1A) If the medicinal product is an advanced therapy medicinal product ... (other than an exempt advanced therapy medicinal product), the package leaflet must contain the information specified in Part 3 of Schedule 27 in the order specified in that Part.
(2) A package leaflet must be included in the packaging of a medicinal product unless all the information required by Part 1 of Schedule 27 (and, where the product contains paracetamol, the information required by Part 2 of that Schedule) , or where the product is an advanced therapy medicinal product ..., the information specified in Part 3 of that Schedule, is conveyed on the outer packaging or the immediate packaging of the product.
(3) A package leaflet relating to a medicinal product must be legible, clear and easy to use, and the applicant for, or holder of, a UK marketing authorisation..., Article 126a authorisation or traditional herbal registration relating to the product must ensure that target patient groups are consulted in order to achieve this.
(4) Regulation (5) applies in a case where a package leaflet is not provided under paragraph (2) because all the information required by Schedule 27 is conveyed on the outer packaging or the immediate packaging of the product.
(5) Where this paragraph applies, any requirement of these Regulations that is expressed by reference to a package leaflet shall be taken to refer to the outer packaging or, as the case may be, the immediate packaging of the product.
(6) Nothing in this regulation or Schedule 27 applies to a registrable homoeopathic medicinal product.

---
Source: https://www.legislation.gov.uk/uksi/2012/1916/regulation/260 (the official version)
Page: https://openlegislation.uk/human-medicines-regulations-2012/regulation-260
Contains public sector information licensed under the Open Government Licence v3.0. Source: legislation.gov.uk, The National Archives.