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PART 11U.K.Pharmacovigilance

Urgent action [F1and major safety review] U.K.

Textual Amendments

Urgent actionU.K.

196.—[F2(1) [F3In the case of a medicinal product authorised for sale or supply under a UKMA(NI), UKMA(UK), THR(NI), THR(UK) or Article 126a authorisation, the licensing authority must inform] 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.

F4(2B) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

(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 [F5(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.

F6(4) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

F6(5) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

F6(6) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

F6(7) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

[F7(8) In this regulation—

F8...

F8...

“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

F2Reg. 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)

[F9Major safety review by the licensing authorityU.K.

196A.—(1) The licensing authority may conduct a major safety review where—

(a)on the basis of concerns resulting from the evaluation of data from pharmacovigilance activities it considers—

(i)suspending or revoking a UK marketing authorisation or traditional herbal registration of a medicinal product or in respect of a class of medicinal products,

(ii)prohibiting the supply of a medicinal product or a class of medicinal products,

(iii)refusing the renewal of a UK marketing authorisation or traditional herbal registration, or

(iv)action is necessary to vary a UK marketing authorisation or traditional herbal registration or a class of such authorisations or registrations, including to impose new conditions; or

(b)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 to which a UK marketing authorisation or traditional herbal registration relates,

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

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

(2) If the licensing authority conducts a review under paragraph (1), it must—

(a)announce the initiation of that review on the UK web-portal as soon as reasonably practicable;

(b)include in that announcement—

(i)an outline of its reasons for conducting a major safety review, the medicinal products concerned and, where applicable, the active substances concerned, and

(ii)the proposed structure and time-scale of the review;

(c)notify a holder if the product to which that holder's authorisation or registration relates is within the scope of the review; and

(d)publish the outcome of that review, including any recommendations it is making, or action it is proposing to take, as soon as reasonably practicable after the conclusion of that review.

(3) A holder who is notified under paragraph (2)(c)—

(a)must provide to the licensing authority such information as the licensing authority notifies that holder it requires, within such time period as the licensing authority specifies; and

(b)may, where such information contains confidential data relevant to the subject matter of the review, because the data relates to a manufacturing process or trade secret, notify the licensing authority that that data is provided in confidence.

(4) Where the licensing authority proposes that action should be taken in respect of any UK marketing authorisation or traditional herbal registration—

(a)during the conduct of the major safety review, because urgent action is necessary to protect public health; or

(b)upon the conclusion of such a review,

it may exercise its powers under Part 5 or 7 (as the case may be) in relation to that authorisation or registration.]

Textual Amendments

EU urgent action procedureU.K.

197.—(1) Where the EU urgent action procedure is initiated in relation to a medicinal product or class of medicinal products [F10authorised for sale or supply under a UKMA(NI), UKMA(UK), THR(NI), THR(UK) or Article 126a authorisation], 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).

Textual Amendments