The Human Medicines Regulations 2012

Urgent action U.K.

196.— [F1 (1) The licensing authority must initiate the Section 4 procedure by informing the specified bodies where, on the basis of concerns resulting from the evaluation of data from pharmacovigilance activities,—

(a) it considers suspending or revoking an authorisation or registration of a medicinal product or class of medicinal products;

(b) it considers prohibiting the supply of a medicinal product or class of medicinal products;

(c) it considers refusing the renewal of an authorisation or registration of a medicinal product; or

(d) it is informed by a holder that, on the basis of safety concerns, the holder has—

(i) interrupted the sale or supply, or offer of sale or supply, of the product,

(ii) taken action to have the product’s authorisation or registration cancelled or intends to do so, or

(iii) not applied for the renewal of the product’s authorisation or registration.

(2) The licensing authority must inform the specified bodies where, on the basis of concerns resulting from the evaluation of data from pharmacovigilance activities, it considers it necessary to vary an authorisation or registration or a class of authorisations or registrations to include—

(a) a new contra-indication,

(b) a reduction to the recommended dose, or

(c) a restriction to the therapeutic indications.

(2A) The information provided under paragraph (2) must outline the action considered and the reasons for the action.

(2B) Where the licensing authority considers urgent action is necessary in relation to the information provided under paragraph (2), it must initiate the Section 4 procedure.

(2C) The information required to be provided under paragraph (1) or (2) must be provided by the end of the day on which the consideration arose under paragraph (1)(a) to (c) or (2) or the information was received under paragraph (1)(d) (as the case may be).]

(3) When informing the EMA under paragraph [F2 (1) or] (2), the licensing authority must make available to the EMA in relation to the medicinal product or class of medicinal products—

(a) all relevant scientific information at its disposal; and

(b) any assessment it has carried out.

(4) Where the EU urgent action procedure does not apply in relation to the medicinal product or class of medicinal products referred to in [F3 paragraph (1) or (2)], the licensing authority—

(a) must inform the holder that it has taken action under [F4 paragraph (1) or (2) (as the case may be)]; and

(b) may take such steps as it sees fit to address the safety concerns.

(5) Where the EU urgent action procedure does apply in relation to the medicinal product or class of medicinal products referred to in [F5 paragraph (1) or (2)], the licensing authority may where the conditions in paragraph (6) are met—

(a) suspend the authorisation or registration of the medicinal product or the authorisations and registrations for the class of medicinal products referred to in [F5 paragraph (1) or (2)] (as the case may be); or

(b) prohibit its or their use within the United Kingdom.

(6) The conditions in this paragraph are that—

(a) urgent action is necessary to protect public health; and

(b) an agreement under Article 107k of the 2001 Directive in respect of the medicinal product or class of medicinal products has not been reached.

(7) Where the licensing authority takes action under paragraph (5), it must by the end of the next working day after the day on which the action is taken inform [F6 the specified bodies] of the reasons for the action F7 ...

[F8 (8) In this regulation—

“EU urgent action procedure” means the procedure under Articles 107j and 107k of the 2001 Directive;

“Section 4 procedure” means the procedure under Section 4 of Chapter 3 of Title IX of the 2001 Directive; and

“specified bodies” means—

(a)

the competent authority of each EEA State other than the United Kingdom,

(b)

the EMA, and

(c)

the European Commission.]

Textual Amendments

F1 Reg. 196(1)-(2C) substituted for reg. 196(1) (11.11.2013) by The Human Medicines (Amendment) (No. 2) Regulations 2013 (S.I. 2013/2593), regs. 1(2), 7(2)

F2 Words in reg. 196(3) inserted (11.11.2013) by The Human Medicines (Amendment) (No. 2) Regulations 2013 (S.I. 2013/2593), regs. 1(2), 7(3)

F3 Words in reg. 196(4) substituted (11.11.2013) by The Human Medicines (Amendment) (No. 2) Regulations 2013 (S.I. 2013/2593), regs. 1(2), 7(4)(a)

F4 Words in reg. 196(4) substituted (11.11.2013) by The Human Medicines (Amendment) (No. 2) Regulations 2013 (S.I. 2013/2593), regs. 1(2), 7(4)(b)

F5 Words in reg. 196(5) substituted (11.11.2013) by The Human Medicines (Amendment) (No. 2) Regulations 2013 (S.I. 2013/2593), regs. 1(2), 7(5)

F6 Words in reg. 196(7) inserted (11.11.2013) by The Human Medicines (Amendment) (No. 2) Regulations 2013 (S.I. 2013/2593), regs. 1(2), 7(6)(a)

F7 Words in reg. 196(7) omitted (11.11.2013) by virtue of The Human Medicines (Amendment) (No. 2) Regulations 2013 (S.I. 2013/2593), regs. 1(2), 7(6)(b)

F8 Reg. 196(8) substituted (11.11.2013) by The Human Medicines (Amendment) (No. 2) Regulations 2013 (S.I. 2013/2593), regs. 1(2), 7(7)