Regulation 71 Withdrawal of medicinal product from the market

United Kingdom

(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 regulation 69 the licensing authority suspends the use, sale, supply or offer for sale or supply within the United Kingdom of a product to which a UK marketing authorisation 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.

Annotations

Textual amendments

F1: Reg. 71(1)(a) substituted (31.12.2020) by The Human Medicines (Amendment etc.) (EU Exit) Regulations 2019 (S.I. 2019/775), regs. 1, 80(2)(a); 2020 c. 1, Sch. 5 para. 1(1)
F2: Reg. 71(1)(b) substituted (1.1.2025) by The Human Medicines (Amendments relating to the Windsor Framework) Regulations 2024 (S.I. 2024/832), regs. 1(1), 57
F3: Words 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