Amendment of regulation 4 of the principal Regulations
5.—(1) Regulation 4 of the principal Regulations (general provisions) shall be amended in accordance with the following paragraphs of this regulation.
(2) In paragraph (1), for the words “such a leaflet” there shall be substituted “a leaflet relating to a proprietary medicinal product other than a relevant medicinal product”.
(3) After paragraph (1) there shall be inserted the following—
“(1A) All particulars contained in such a leaflet as is described in regulation 3 above relating to a relevant medicinal product shall be drawn up in accordance—
(a)with the summary of product characteristics, if there is one;
(b)if there is no summary of product characteristics, with the data sheet, if there is one;
(c)if there is no summary of product characteristics and no data sheet, with the information which would be required to accompany an application for a product licence by virtue of Article 4a of Council Directive 65/65/EEC.”.
(4) In paragraph (2)—
(a)the word “such” shall be omitted;
(b)after the word “shall” shall be inserted the words “be written in clear and understandable terms for the patient, be clearly legible and”; and
(c)at the end of that paragraph, there shall be inserted the following:—
“but particulars contained in a leaflet relating to a relevant medicinal product may be given in English and in one or more other languages provided that the same particulars appear in all the languages used.”.
(5) In paragraph (3) for the words “such leaflet” there shall be substituted “leaflet relating to a proprietary medicinal product other than a relevant medicinal product”.
(6) Paragraph (5) shall be omitted.
(7) In paragraph (6)—
(a)for “the Schedule” there shall be substituted “Schedule 1”; and
(b)for “such a leaflet” there shall be substituted “a leaflet relating to a proprietary medicinal product other than a relevant medicinal product”.
After paragraph (6) there shall be inserted the following paragraphs—
“(7) The particulars set out in paragraph 2 of Schedule 2 to these regulations shall not be required to be included in a leaflet relating to a relevant medicinal product where the product licence which relates to that product contains a provision directing that such particulars shall not be so included.
(8) A leaflet relating to a relevant medicinal product may include—
(a)a symbol or pictogram designed to clarify the particulars set out in Schedule 2 to these regulations;
(b)other information in accordance with paragraph (1A) of this regulation which is useful for health education,
to the exclusion of any element of a promotional nature.
(9) Where a leaflet—
(a)relates to a relevant medicinal product which is available in more than one pharmaceutical form or in more than one strength, and
(b)the name of that product does not include its pharmaceutical form or an indication of its strength,
there shall be added immediately after the name as required by paragraph 1 of Schedule 2 to these regulations, in the same style and size of letters as the name, a statement of the pharmaceutical form and an indication of the strength or both (as appropriate) of that product; and in this paragraph “strength” means the suitability of the product for a baby, child or adult.”.