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The Human Medicines Regulations 2012

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Changes over time for: Section 256L

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[F1Variation of a person’s entry on the list on the application of that personU.K.

This adran has no associated Memorandwm Esboniadol

256L.—(1) This regulation applies if a person entered on the list applies to the [F2licensing authority] for a variation of the person’s entry on the list.

(2) The application must—

(a)be in writing;

(b)specify the variation requested;

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

(d)be accompanied by such information as may be required to enable the [F2licensing authority] to consider the application.

(3) The [F2licensing authority] must vary a person’s entry on the list or refuse to vary it within 30 days beginning with the day after the date when [F3the licensing authority] receives the application.

(4) The [F2licensing authority] may give a notice to the applicant requiring the applicant to supply further information in connection with the application within the period specified in the notice.

(5) If a notice under paragraph (4) requires the applicant to provide the [F2licensing authority] with information, the information period is not to be counted for the purposes of paragraph (3).

(6) In paragraph (5), the “information period” means the period—

(a)beginning with the day on which notice under paragraph (4) is given; and

(b)ending with the day on which the [F2licensing authority] receives the information or the applicant shows to [F4the licensing authority's] satisfaction that the applicant is unable to provide it.

(7) Nothing in this regulation affects the powers conferred by regulations 256I and 256K.]

Textual Amendments

F1Pt. 12A inserted (coming into force in accordance with reg. 1(2) of the amending S.I.) by The Human Medicines (Amendment) Regulations 2013 (S.I. 2013/1855), regs. 1(2), 28

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