The Human Medicines Regulations 2012

Urgent action

Urgent action

196.—(1) This regulation applies where the licensing authority forms the view that as a result of the evaluation of data resulting from pharmacovigilance activities urgent action is necessary in connection with—

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

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

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

(d) receiving information from the holder that, on the basis of safety concerns, the holder has interrupted the sale or supply, or offer for sale or supply, of the product or that the holder has taken action to have the product’s authorisation or registration cancelled or that the holder intends to do so; or

(e) considering whether the terms of the authorisation or registration of a medicinal product or class of medicinal products should be varied to include a new contra-indication, an alteration of a recommended dose or a restriction to the therapeutic indications.

(2) The licensing authority must provide information about the urgent action it considers necessary by the end of the day following the day on which the view under paragraph (1) was formed to—

(a) the competent authorities of the EEA States other than the United Kingdom;

(b) the EMA; and

(c) the European Commission.

(3) When informing the EMA under paragraph (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 paragraph (1), the licensing authority—

(a) must inform the holder that it has taken action under paragraph (2); 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 paragraph (1), 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 paragraph (1) (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 of the reasons for the action the following—

(a) the European Commission;

(b) the EMA; and

(c) the competent authority of each EEA State other than the United Kingdom.

(8) In this regulation “the EU urgent action procedure” means the procedure under Articles 107j and 107k of the 2001 Directive.

EU urgent action procedure

197.—(1) Where the EU urgent action procedure is initiated in relation to a medicinal product or class of medicinal products, the licensing authority—

(a) may publicly announce the initiation of the EU urgent action procedure on the UK web-portal; and

(b) must implement the measures set out in any agreement reached under Article 107k of the 2001 Directive in relation to the medicinal product or class of medicinal products in accordance with the implementation timetable determined in the agreement.

(2) Paragraph (3) applies where an agreement under Article 107k of the 2001 Directive in relation to a medicinal product or class of medicinal products requires a variation to be made to one or more authorisation or registration.

(3) Each holder of an authorisation or registration covered by the agreement referred to in paragraph (2) must submit to the licensing authority in accordance with the terms of the agreement (including its implementation timetable) an application for a variation in respect of the authorisation or registration including—

(a) an updated summary of the product characteristics; and

(b) an updated package leaflet.

(4) In this regulation, “EU urgent action procedure” has the same meaning as it is given in regulation 196(8).