SCHEDULES

SCHEDULE 29Labelling of traditional herbal medicinal products

Regulation 265

PART 1Traditional herbal medicinal products: general

1

A statement to the effect that the product is a traditional herbal medicinal product, for use for specific purposes by reason of long-standing use.

2

A statement that the user should consult a doctor or other health care practitioner if symptoms persist during use of the medicinal product, or if adverse effects not mentioned on the package or package leaflet occur.

PART 2Traditional herbal medicinal products not subject to general sale

3

Subject to the provisions of regulation 265(2), paragraph 4 applies where a traditional herbal medicinal product that is a pharmacy medicine is—

a

sold by retail;

b

supplied in circumstances corresponding to retail sale;

c

in the possession of a person for the purpose of sale or supply as mentioned in paragraph (a) or (b); or

d

distributed by way of wholesale dealing.

4

Where this paragraph applies, the outer packaging and the immediate packaging of the product must be labelled to show the capital letter “P” within a rectangle, within which there is to be no other matter of any kind.