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The Human Medicines Regulations 2012

Changes over time for: Section 71

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Withdrawal of medicinal product from the marketU.K.

This section has no associated Explanatory Memorandum

71.—(1) This regulation applies if—

[F1(a)under regulation 68 the licensing authority revokes or suspends a UK marketing authorisation or parallel import licence; or]

[F2(b)under—

(i)regulation 69 the licensing authority suspends the use, sale, supply or offer for sale or supply within Great Britain of a product to which a UKMA(GB) relates; or

(ii)regulation 69 or Article 20(4) of Regulation (EC) No 726/2004 the licensing authority suspends the use, sale, supply or offer for sale or supply within Northern Ireland of a product to which a UKMA(NI) or UKMA(UK) relates.]

(2) The licensing authority may give written notice to the person who is, or immediately before its revocation was, the holder of the authorisation [F3or related parallel import licence] requiring that person 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 authorisation 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.

Textual Amendments

F3Words in reg. 71(2) inserted (E.W.S.) (1.10.2014) by The Human Medicines (Amendment) (No. 2) Regulations 2014 (S.I. 2014/1878), regs. 1, 13 and words in reg. 71(2) inserted (N.I.) (1.10.2014) by The Human Medicines (Amendment) (No. 2) Regulations 2014 (S.R. 2014/324), regs. 1(1), 13

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