The Medicines (Traditional Herbal Medicinal Products for Human Use) Regulations 2005

Dispensed traditional herbal medicinal products

3.—(1) Subject to the following provisions of this Schedule, where a traditional herbal medicinal product is a dispensed traditional herbal medicinal product the container of that product shall be labelled to show the following particulars—

(a) where the traditional herbal medicinal product is for use by being administered to a particular human being, the name of the person to whom the traditional herbal medicinal product is to be administered;

(b) the name and address of the person who sells or supplies the traditional herbal medicinal product;

(c) the date on which the traditional herbal medicinal product is dispensed; and

(d) where the traditional herbal medicinal product has been prescribed by a practitioner, such of the following particulars as he may request—

(i) the name of the traditional herbal medicinal product or its common name,

(ii) directions for use of the traditional herbal medicinal product, and

(iii) precautions relating to the use of the traditional herbal medicinal product,

or where a pharmacist, in the exercise of his professional skill and judgement, is of the opinion that any of such particulars are inappropriate and has taken such steps as in all the circumstances are reasonably practicable to consult with the practitioner but has been unable to do so, particulars of the same kind as those requested by the practitioner as appear to the pharmacist to be appropriate.

(2) Where the container of a dispensed traditional herbal medicinal product is enclosed in a package immediately enclosing that container the particulars set out in sub-paragraph (1) may be omitted from the container if that package is labelled to show such particulars.

(3) Where a number of containers or packages, or of containers and packages, of dispensed traditional herbal medicinal products all of the same description are enclosed in a package, sub-paragraph (1)(d) shall be deemed to have been complied with if such of the particulars referred to in that sub-paragraph as would, apart from this sub-paragraph, be required to be shown on each container or package, or on each container and package so enclosed, are shown on either one or more such containers or packages or such containers and packages as the case may be.