The Medicines for Human Use (Marketing Authorisations Etc.) Regulations 1994

Exemptions

8.  Nothing in this Schedule shall require the labelling of—

(a) any package in the form of a transparent wrapping or cover to a container and package of a relevant medicinal product or any package the whole or part of which is transparent or open if the particulars shown on the labelled container enclosed in that package are clearly visible;

(b) any package in the form of a wrapping paper, paper bag or similar covering in which the container and package of a relevant medicinal product labelled in accordance with the provisions of this Schedule is placed when such relevant medicinal product is sold by retail or supplied in circumstances corresponding to retail sale; or

(c) any container or package immediately enclosing the container of a relevant medicinal product which is for export;

(d) any container which is—

(i) an ampoule or other container of not more than 10 millilitres nominal capacity which is immediately enclosed in a package which is labelled in accordance with those provisions of paragraphs 5 to 7 which apply to such package;

(ii) in the form of a wrapper consisting of paper, film, plastic material, metal foil or other sheet or strip material or in the form of a bubble, blister or other sealed unit consisting of such sheet or strip material, enclosing one or more dosage units of a relevant medicinal product and such container is immediately enclosed in a package which is labelled in accordance with those provisions of paragraphs 5 to 7 which apply to such package;

(iii) where the package immediately enclosing such a container as is described in head (ii) above is itself in the form of a bubble, blister or other sealed unit as is mentioned in that head and is part of a continuous series comprising a sheet or strip of like packages and is required to be labelled to show any of the words, particulars or letters referred to in paragraphs 5 to 7, such requirements shall be deemed to have been complied with if the said words, particulars or letters, as the case may be, are displayed at frequent intervals on the said sheet or strip of such packages.