The Human Medicines Regulations 2012

Variation of licence on the application of the holder U.K.

29.—(1) This regulation applies if the holder of a licence under this Part applies to the licensing authority for a variation of the licence.

(2) The application must—

(a) be in writing;

(b) specify the variation requested;

(c) be signed by or on behalf of the applicant;

(d) be accompanied by such information as may be required to enable the licensing authority to consider the application; and

(e) be accompanied by the required fee (if any).

(3) The licensing authority must consider an application made in accordance with this regulation.

(4) If paragraph (5) applies, the licensing authority must vary the licence or refuse to vary it before the end of the period allowed for considering the application.

(5) This paragraph applies to a variation which would have the effect of altering—

(a) the types of medicinal product in respect of which the licence was granted;

(b) any operation carried out under the licence; F1 ...

(c) any premises, equipment or facilities in respect of which the licence was [F2 granted; or]

[F3 (d) the responsible person (import) under regulation 45AA.]

(6) The period allowed for consideration of an application under this regulation is—

(a) in a case where the licensing authority considers that it is necessary to inspect premises to which the licence relates, 90 days beginning with the day after the date when the licensing authority receives the application; and

(b) in any other case 30 days beginning with that day.

(7) The licensing authority may give a notice to the applicant requiring the applicant to supply further information in connection with the application.

(8) If a notice under paragraph (7) requires the applicant to provide the licensing authority with information, the information period is not to be counted for the purposes of paragraph (6).

(9) In paragraph (8), the “information period” means the period—

(a) beginning with the day on which the notice is given; and

(b) ending with the day on which the licensing authority receives the information or the applicant shows to the licensing authority's satisfaction that the applicant is unable to provide it.

(10) Nothing in this regulation affects the powers conferred by regulation 26.

Textual Amendments

F1 Word in reg. 29(5)(b) omitted (31.12.2020) by virtue of The Human Medicines (Amendment etc.) (EU Exit) Regulations 2019 (S.I. 2019/775), regs. 1, 23(a); 2020 c. 1, Sch. 5 para. 1(1)

F2 Words in reg. 29(5)(c) substituted (31.12.2020) by The Human Medicines (Amendment etc.) (EU Exit) Regulations 2019 (S.I. 2019/775), regs. 1, 23(b); 2020 c. 1, Sch. 5 para. 1(1)

F3 Reg. 29(5)(d) inserted (31.12.2020) by The Human Medicines (Amendment etc.) (EU Exit) Regulations 2019 (S.I. 2019/775), regs. 1, 23(c); 2020 c. 1, Sch. 5 para. 1(1)