Regulation 181 Delegation of obligations under this Part

(1)

The licensing authority may delegate any of its obligations under this Part F1in connection with its pharmacovigilance system in relation to medicinal products for sale or supply in Northern Ireland F2pursuant to a UKMA(NI) or a UKMA(UK)(Category 2) to an EEA State where the conditions in paragraph (2) are met.

(2)

The conditions in this paragraph are that the EEA State to whom the obligations are to be delegated—

(a)

has given its written agreement to the delegation; and

(b)

is not performing delegated obligations under this Part on behalf of another EEA State.

(3)

Where the licensing authority has delegated any of its obligations under paragraph (1), it must—

(a)

inform the European Commission, the EMA and all other EEA States in writing of the delegation as soon as is reasonably practicable; and

(b)

make the delegation public as soon as is reasonably practicable.

(4)

The licensing authority may agree to carry out any of the obligations of another EEA State under Title IX of the 2001 Directive on a delegated basis, but may carry out obligations under that Title only for one EEA State at any time.

Annotations

Textual amendments

F1: Words in reg. 181(1) substituted (31.12.2020) by S.I. 2019/775, reg. 141 (as substituted by The Human Medicines (Amendment etc.) (EU Exit) Regulations 2020 (S.I. 2020/1488), reg. 1, Sch. 2 para. 110)
F2: Words in reg. 181(1) inserted (1.1.2025) by The Human Medicines (Amendments relating to the Windsor Framework) Regulations 2024 (S.I. 2024/832), regs. 1(1), 76