Regulation 4 General provisions
All particulars contained in such a leaflet as is described in regulation 3 above, including the particulars required to be so contained by these regulations, shall be consistent with the provisions of any product licence granted under Part II of the Act in respect of the proprietary medicinal product which relates to such particulars.
All particulars required by these regulations to be contained in such a leaflet shall, except with respect to numerals, be given in the English language.
Except as provided in paragraph (4) below no such leaflet shall contain any reference to a medicinal product of any description other than the proprietary medicinal product with which that leaflet is supplied or is intended to be supplied.
Notwithstanding the provisions of paragraph (3) above such a leaflet which—
contains instructions solely in respect of the use of an apparatus or appliance for the purpose of administration of the proprietary medicinal product to which the leaflet relates, being instructions that are capable of having equal application to other medicinal products having the same pharmaceutical form, or
contains the particulars set out in paragraphs 4 to 8 of the Schedule to these regulations, being particulars that would be the same in all respects in relation to other medicinal products of a different description, or
contains any reference to a medicinal product other than the proprietary medicinal product to which the leaflet relates in so far as such reference is necessary to explain the contra-indications or precautions or the action to be taken in the event of overdosage of the proprietary medicinal product to which that leaflet relates,
may contain references to such other medicinal products.
The particulars required by these regulations to be contained in such a leaflet shall be clearly separate from the remainder of the contents of the leaflet.
The particulars set out in paragraphs 4 and 5 of the Schedule to these regulations shall not be required to be included in such a leaflet where—
it is a provision of the product licence which relates to the proprietary medicinal product that the product is to be sold or supplied only by an appropriate practitioner or in accordance with a prescription given by a practitioner, or
the proprietary medicinal product is a product which is of a description or falls within a class specified in an order made under section 58(1) of the Act (medicinal products on prescription only) and which is subject to the restrictions imposed by section 58(2) of the Act, or
the product licence which relates to the proprietary medicinal product contains a provision directing that such particulars shall not be so included.