The Medicines (Leaflets) Regulations 1977

Approval of contents of leaflets

5.—(1) The holder of a product licence which relates to a proprietary medicinal product shall send or deliver to the licensing authority a copy of the particulars to be included in any leaflet as aforesaid not less than 42 days (or such shorter period as the authority may allow) before the first supply of the leaflet.

(2) Where the holder of a product licence has delivered a copy of the particulars to be included in such a leaflet to the licensing authority in accordance with paragraph (1) of this regulation and he has been informed in writing by the licensing authority, not later than 21 days after receipt of such particulars by the authority, that a leaflet containing such particulars ought not to be so supplied, or ought to be supplied only in a modified form, the holder of the licence shall not supply, or cause another person to supply, any such leaflet containing such particulars or, as the case may be, such particulars other than in a modified form, unless the consent of the licensing authority has been given in writing.

(3) Any person who contravenes this regulation shall be guilty of an offence and shall be liable—

(a) on summary conviction, to a fine not exceeding £400;

(b) on conviction on indictment, to a fine or to imprisonment for a term not exceeding two years or to both.