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62.—(1) By way of derogation from the provisions of these Regulations requiring a marketing authorisation, a homoeopathic medicinal product may be placed on the market in accordance with a registration by the Secretary of State instead of a marketing authorisation if it complies with this paragraph.
(2) It must not be an immunological product.
(3) The route of administration must be as described in the European Pharmacopoeia or, if it is not described there, by a pharmacopoeia currently used officially in any member State.
(4) 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.
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