Paragraph 63 Placing a homeopathic remedy on the market in accordance with a registrationE1

By way of derogation from the provisions of these Regulations requiring a marketing authorisation for a veterinary medicinal product, a homeopathic remedy may be placed on the market in accordance with a registration by the Secretary of State instead of in accordance with a marketing authorisation if it complies with this paragraph.

It must not be an immunological F1or, subject to sub-paragraph (2A), a biological product.

Sub-paragraph (2) does not apply in relation to a homeopathic remedy which is derived from plants.

The route of administration must be F3either topical or oral and must be as described in the European PharmacopoeiaF4....

There must be a sufficient degree of dilution to guarantee the safety of the product, and in any event it must not contain more than one part in 10,000 of the mother tincture.

All other provisions relating to marketing authorisations apply in the same way to registrations of a homeopathic remedy.