Chinese Herbal Remedy selling chinese herbal products worldwide
shipping guideThe Medicines Control Agency (MCA) is responsible for the administration and enforcement of medicines legislation in the UK. Products containing culinary herbs would not usually be considered medicines unless claims to treat or prevent disease were made for them.

However, some herbs have well- known pharmacological effects and would usually only be found in products for a medicinal purpose. Such products would require marketing authorisations (formerly known as product licences) unless they enjoyed the exemption mentioned below.

All herbal remedies sold or supplied in the UK are controlled under the Medicines For Human Use (Marketing Authorisations Etc.) Regulations 1994 (S.I.1994/3144) and the Medicines Act 1968 (the Act). This does not include herbal products which do not satisfy the definition of a medicinal product contained in Article 1.2 of Council Directive 65/65/EEC which reads:

"Any substance or combination of substances presented for treating or preventing disease in human beings or animals. Any substance or combination of substances which may be administered to human beings or animals with a view to making a medical diagnosis or to restoring, correcting or modifying physiological function in human beings or in animals is likewise considered a medicinal product."

Section 132 of the Act defines a herbal remedy as:

".... a medicinal product consisting of a substance produced by subjecting a plant or plants to drying, crushing or any other process, or of a mixture whose sole ingredients are two or more substances so produced, or of a mixture whose sole ingredients are one or more substances so produced and water or some other inert substance."

The legislation provides that , in general, medicinal products cannot be placed on the market unless a marketing authorisation has been granted in accordance with Community provisions by the licensing authority or the European Commission.

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.