The Human Medicines Regulations 2012

[F1 Register for responsible persons (import) U.K.

45AB.— (1) The licensing authority must maintain a register of persons (“the responsible person (import) register”) who may carry out the role of responsible person (import) under regulation 45AA.

(2) The licensing authority may only include a person's name in the responsible person (import) register if that person—

(a) holds—

(i) a diploma, certificate or other evidence of formal qualifications awarded on completion of a university or other higher education course of study in pharmacy, chemistry, medicine, biology or a related life science, or

(ii) such other qualification as the licensing authority is satisfied is equivalent;

(b) is a member of—

(i) the Royal Society of Biology,

(ii) the Royal Pharmaceutical Society,

(iii) the Pharmaceutical Society of Northern Ireland,

(iv) the Royal Society of Chemistry, or

(v) such other body as may be specified by the licensing authority for the purpose of this paragraph; and

(c) has a minimum of 2 years' experience in performing the functions of a responsible person under regulation 45, or in performing such other functions that appear to the licensing authority to be equivalent.

(3) The licensing authority—

(a) may remove a person's name from the responsible person (import) register if it no longer considers that the person satisfies the requirements of paragraph (2); but

(b) it may not exercise that power unless it has given that person the opportunity to make representations to it (orally or in writing).]

Textual Amendments

F1 Regs. 45AA, 45AB inserted (31.12.2020) by The Human Medicines (Amendment etc.) (EU Exit) Regulations 2019 (S.I. 2019/775), regs. 1, 37 (as amended by S.I. 2020/1488, reg. 1, Sch. 2 para. 27); 2020 c. 1, Sch. 5 para. 1(1)