The Medicines (Leaflets) Regulations 1977

Regulation 3

SCHEDULE PARTICULARS REQUIRED TO BE INCLUDED IN LEAFLETS

1.  The appropriate non-proprietary name of the proprietary medicinal product (if any) and a proprietary designation.

2.  A statement of the appropriate quantitative particulars of the proprietary medicinal product and, where ingredients other than active ingredients are stated, distinguishing between such ingredients as are and such ingredients as are not active ingredients and, where the quantities stated are those from which the product has been prepared, such quantities being preceded by a statement to that effect, except that where any medicinal product or ingredient is identified by reference to a name, or abbreviation of a name, at the head of a monograph in a specified publication and the quantity of that product or ingredient is stated, the requirements of this paragraph shall be regarded as having been complied with.

3.  Where any ingredient has an international non-proprietary name, that name, except that particulars of the international non-proprietary name shall not be required to be given where there is an insignificant difference between the spelling of that international non-proprietary name and such name at the head of a monograph or approved synonym or approved name.

4.  Directions for use of the proprietary medicinal product.

5.  Therapeutic indications for the proprietary medicinal product.

6.  Contra-indications, warnings and precautions including any contra-indications, warnings and precautions required to be given by the provisions of any product licence relating to the proprietary medicinal product and thereby required to be addressed to the person to or by whom the product is to be administered.

7.  Any special requirements for the handling and storage of the proprietary medicinal product.

8.—(a) The name and address of the holder of the product licence which relates to the proprietary medicinal product or the business name and address of the part of his business that is responsible for its sale or supply, or

(b) where the provisions of the product licence which relates to the proprietary medicinal product or a manufacturer's licence authorising the assembly of the product permit, or where the proprietary medicinal product is assembled by or under the supervision of a pharmacist in accordance with the provisions of section 10(1)(b) or 10(6) of the Act, the name and address of a person who sells the proprietary medicinal product by retail or supplies it in circumstances corresponding to retail sale.

9.  The name and address of the person who has manufactured the proprietary medicinal product and, if different therefrom, the name and address of the person in the course of whose business the proprietary medicinal product was enclosed in its container, except that such requirement shall be treated as having been complied with if—

(a) one person only has manufactured the proprietary medicinal product, or

(b) more than one person has manufactured medicinal products of the same description as the proprietary medicinal product and the licensing authority have been notified of the names of the persons who have manufactured medicinal products of the same description and have directed that the name and address of any such person may be omitted.