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The Human Medicines Regulations 2012

Changes over time for: Section 138

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Suspension of use etc of traditional herbal medicinal productU.K.

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138.—(1) The licensing authority may suspend the use, sale, supply or offer for sale or supply within the United Kingdom of a product to which a traditional herbal registration relates if any of the following conditions are met.

(2) Condition A is that the licensing authority thinks that—

(a)the product is harmful;

(b)the pharmacological effects or efficacy of the product are no longer plausible; or

(c)the product's qualitative or quantitative composition is not as described in the application for the registration or the material accompanying it.

(3) Condition B is that the licensing authority thinks that the holder has not complied with regulation 145(7) (requirements to provide proof of controls on manufacturing process).

(4) Condition C is that the licensing authority thinks that there has been a breach of—

(a)a term of the registration; or

(b)a requirement imposed by Chapter 1 of Part 13 (packaging and leaflets).

(5) Condition D is that the licensing authority thinks that paragraph (4) or (5) of regulation 23 (power to revoke, suspend or vary manufacturers' licences) applies in relation to the manufacturer's licence for the product.

(6) A suspension under this regulation may relate to batches of the product.

(7) The licensing authority must give notice in writing of a suspension under this regulation to the holder of the registration.

(8) The licensing authority must provide in the notice that the suspension—

(a)is to take effect immediately or from a date specified in the notice; and

(b)is to apply for the period specified in the notice.

(9) Where a medicinal product is the subject of a suspension under this regulation, the licensing authority may—

(a)in exceptional circumstances; and

(b)for such a transitional period as the licensing authority may determine,

allow the supply of the medicinal product to patients who are already being treated with the medicinal product.

(10) This regulation is subject to regulation 139 (registrations granted under Chapter 4 of Title III of the 2001 Directive).

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