# The Human Medicines Regulations 2012, Regulation 181: Delegation of obligations under this Part


(1) The licensing authority may delegate any of its obligations under this Part in connection with its pharmacovigilance system in relation to medicinal products for sale or supply in Northern Ireland pursuant 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.

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Source: https://www.legislation.gov.uk/uksi/2012/1916/regulation/181 (the official version)
Page: https://openlegislation.uk/human-medicines-regulations-2012/regulation-181
Contains public sector information licensed under the Open Government Licence v3.0. Source: legislation.gov.uk, The National Archives.