General provisions
9. (1) All labelling of containers of medicinal products or medicated feeding stuffs shall be carried out in an indelible manner on, or in such a way that the label is attached to, the body of the container, except that, where the container is a transparent container, such labelling may be carried out inside the body of the container.
(2) All labelling of packages of medicinal products or medicated feeding stuffs shall be carried out in an indelible manner.
(3) Where a medicinal product or excepted medicated feeding stuff contains a single active ingredient and particulars of the appropriate non-proprietary name of such ingredient are required by these Regulations to be shown on the container of the medicinal product or excepted medicated feeding stuff or on the container of the medicated feeding stuff in which the medicinal product or excepted medicated feeding stuff has been incorporated, such appropriate non-proprietary name shall be shown in prominent lettering on the container.
(4) All particulars required by these Regulations to be shown on any labelling of any container or package of a medicinal product or medicated feeding stuff or contained in any leaflet supplied with such medicinal product or medicated feeding stuff shall, except with respect to numerals, be given in the English language, except that—
(a) where the name of a herbal remedy or ingredient of a herbal remedy at the head of a specified publication is a botanical name, that botanical name may be given, or
(b) where the name of a medicinal product or excepted medicated feeding stuff is in a language other than English but is the name by which that medicinal product or excepted medicated feeding stuff is usually known in the United Kingdom, that name may be given,
but nothing in this regulation shall prohibit such particulars being given in two or more languages where one of those languages is English.
(5) All particulars referred to in paragraph (4) above shall be clear, legible and readily discernible so as to be easily read by an intending purchaser or user of the medicinal product or medicated feeding stuff under normal conditions of purchase or use.
(6) No labelling of any container or package of a medicinal product or medicated feeding stuff or particulars contained in any leaflet supplied with such medicinal product or medicated feeding stuff shall include any reference, direct or indirect, to the Act or any regulations (including these Regulations) or orders made under the Act or to the Medicines Commission or to any committee established under section 4 of the Act or to any licence or certificate granted or issued under the Act, unless such reference is required by or made pursuant to the provisions of the Act or such regulations, orders, licence or certificate.
(7) Every container and package of a medicinal product or excepted medicated feeding stuff, not being a container or package of a medicinal product or excepted medicated feeding stuff for administration in a medicinal test on animals, shall be labelled to show the words “For Animal Treatment Only” except that, where such container or package is of so small a size that it is not reasonably practicable to show such words, they may be omitted.
(8) Every leaflet supplied with a medicinal product or excepted medicated feeding stuff, not being a leaflet supplied with a medicinal product or excepted medicated feeding stuff for administration in a medicinal test on animals, or a leaflet which is a data sheet, shall contain the words “For Animal Treatment Only”.