The Human Medicines Regulations 2012

Withdrawal of traditional herbal medicinal product from the market

140.—(1) This regulation applies if—

(a) under regulation 135, 136, 139(2) or Article 34(3) of the 2001 Directive the licensing authority revokes or suspends a traditional herbal registration; or

(b) under regulation 138 the licensing authority suspends the use, sale, supply or offer for sale or supply within the United Kingdom of a product to which a traditional herbal registration relates.

(2) The licensing authority may give written notice to the person who is, or immediately before its revocation was, the holder of the registration requiring the holder to comply with both of the following requirements.

(3) Requirement A is to take all reasonably practicable steps to inform wholesalers, retailers, medical practitioners, patients and others who may be in possession of the product to which the registration relates of—

(a) the revocation or suspension;

(b) the reasons for the revocation or suspension; and

(c) any action to be taken to restrict or prevent further use, sale, supply or offer for sale or supply of the product.

(4) Requirement B is to take all reasonably practicable steps to withdraw from the market in the United Kingdom and recover possession of—

(a) the product; or

(b) the batches of the product specified in the notice,

within the time and for the period specified in the notice.