Regulation 196 Urgent action

United Kingdom

F1(1)

F2In the case of a medicinal product authorised for sale or supply under a UKMA(NI), F3UKMA(UK)(Category 2), 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)

. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

(5)

. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

(6)

. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

(7)

. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

F7(8)

In this regulation—

F8...
...
“specified bodies” means—
1. (a)
  the competent authority of each EEA State other than the United Kingdom,
2. (b)
  the EMA, and
3. (c)
  the European Commission.

Annotations

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(1) substituted (31.12.2020) by S.I. 2019/775, reg. 156(ZA)(b) (as inserted by The Human Medicines (Amendment etc.) (EU Exit) Regulations 2020 (S.I. 2020/1488), reg. 1, Sch. 2 para. 123)
F3: Words in reg. 196(1) substituted (1.1.2025) by The Human Medicines (Amendments relating to the Windsor Framework) Regulations 2024 (S.I. 2024/832), regs. 1(1), 87
F4: Reg. 196(2B) omitted (31.12.2020) by virtue of S.I. 2019/775, reg. 156(ZA)(c) (as inserted by The Human Medicines (Amendment etc.) (EU Exit) Regulations 2020 (S.I. 2020/1488), reg. 1, Sch. 2 para. 123)
F5: 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)
F6: Reg. 196(4)-(7) omitted (31.12.2020) by virtue of S.I. 2019/775, reg. 156(ZA)(d) (as inserted by The Human Medicines (Amendment etc.) (EU Exit) Regulations 2020 (S.I. 2020/1488), reg. 1, Sch. 2 para. 123)
F7: 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)
F8: Words in reg. 196(8) omitted (31.12.2020) by virtue of S.I. 2019/775, reg. 156(ZA)(e) (as inserted by The Human Medicines (Amendment etc.) (EU Exit) Regulations 2020 (S.I. 2020/1488), reg. 1, Sch. 2 para. 123)

Notes on Urgent action and major safety review

Textual amendments

F1: Words in reg. 196 cross-heading inserted (31.12.2020) by S.I. 2019/775, reg. 156(ZA)(a) (as inserted by The Human Medicines (Amendment etc.) (EU Exit) Regulations 2020 (S.I. 2020/1488), reg. 1, Sch. 2 para. 123)