|However, certain herbal remedies are allowed exemption from licensing when they meet the conditions laid down in Section 12 of the Medicines Act.
Section 12 (1) allows a person to make, sell and supply a herbal remedy during the courses of their business provided the remedy is manufactured or assembled on the premises and that it is supplied as a consequence of a consultation between the person and their patient.
Section 12 (2) allows the manufacture, sale or supply of herbal remedies (other than by the personal consultation) where:-
(i) the process to which the plant or plants are subjected consists of only of drying, crushing or comminuting:
(ii) the remedy is sold without any written recommendation as to it's use, and
(iii) the remedy is sold under a designation which only specifies the plant(s) and the process, and does not apply any other name to the remedy.
There are further controls on the retail sale of medicinal products including herbal remedies in Sections 52, 53 and 56 of the Medicines Act. Sections 52 and 53 regulate the conditions under which medicinal products may be retailed; Section 56 provides exemptions from these conditions for certain medicinal products which are herbal remedies. These exemptions are however, limited by The Medicines (Retail Sale or Supply of Herbal Remedies) Order 1977 (S.I. 1977/2130). Products containing the substances listed in Part 1 of the Schedule to the Order are excluded from the Section 56 exemption and may not be sold other than through a registered pharmacy.
To sum up, to claim the exemption from the requirement to have a marketing authorisation, the product must be a medicinal product and also a herbal remedy within the definitions in the legislation. Its sale or supply must also satify the conditions laid down in Sections 12 and 56 of the Medicines Act. Otherwise it must be licensed/ authorised, as previously described.
These notes are for guidance only, and may be subject to change and development over time where experience shows this to be necessary. They should not be taken as a complete or definitive statement of the law.