S.L. 458.33 Art. 5Clarity of particulars.

(1) The particulars referred to in regulations 3, 4 and 9

shall be easily legible, clearly comprehensible and indelible.

(2) The name of the medicinal product, as referred to in regulation 3(a), must also be expressed in Braille format on the packaging. The marketing authorisation holder shall ensure that the package information leaflet is made available on request from patients’ organisations in formats appropriate for the blind and partially-sighted.