The Human Medicines Regulations 2012

Requirement as to responsible personsU.K.
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45.—(1) The licence holder must ensure that there is available at all times at least one person (referred to in this regulation as the “responsible person”) who in the opinion of the licensing authority—

(a)has knowledge of the activities to be carried out and of the procedures to be performed under the licence which is adequate to carry out the functions mentioned in paragraph (2); and

(b)has adequate experience relating to those activities and procedures.

[F1(1A) In respect of a licence holder in Great Britain, paragraph (1) is subject to regulation 45AA.]

(2) Those functions are—

(a)ensuring that the conditions under which the licence was granted have been, and are being, complied with; and

[F2(b)ensuring that the quality of medicinal products handled by the licence holder is being maintained in accordance with the requirements of—

(i)in the case of a licence holder in Great Britain, the UK marketing authorisations, certificates of registration or traditional herbal registrations, and

(ii)in the case of a licence holder in Northern Ireland, the marketing authorisations, [F3requirements of regulation 167A,] Article 126a authorisations, certificates of registration or traditional herbal registrations,

applicable to those products.]

(3) The licence holder must notify the licensing authority of—

(a)any change to the responsible person; and

(b)the name, address, qualifications and experience of the responsible person.

(4) The licence holder must not permit any person to act as a responsible person other than the person named in the licence or another person notified to the licensing authority under paragraph (3).

(5) Paragraph (6) applies if, after giving the licence holder and a person acting as a responsible person the opportunity to make representations (orally or in writing), the licensing authority thinks that the person—

(a)does not satisfy the requirements of paragraph (1) in relation to qualifications or experience; or

(b)is failing to carry out the functions referred to in paragraph (2) adequately or at all.

(6) Where this paragraph applies, the licensing authority must notify the licence holder in writing that the person is not permitted to act as a responsible person.

Textual Amendments