The Human Medicines Regulations 2012

[F1Procedure for listing persons who may supply medicinal products at a distanceU.K.

This section has no associated Explanatory Memorandum

256D.—(1) If the [F2licensing authority] receives a notification under regulation 256C it must accept or refuse to include that person on the list within the period of 90 days beginning immediately after the day on which the notification is received by the authority.

(2) Paragraph (1) applies only if the requirements of regulation 256C(2) have been met.

(3) Before determining if a person can be included on the list, the [F2licensing authority] may require the person giving the notification to provide such information as [F3the licensing authority] thinks necessary, within the period specified by [F3the licensing authority].

(4) If a notice under paragraph (3) requires the person giving the notification to provide the [F2licensing authority] with information, the information period is not to be counted for the purposes of paragraph (1).

(5) In paragraph (4), 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—

(i)the [F2licensing authority] receives the information; or

(ii)the person from whom the information is requested shows to the satisfaction of the [F2licensing authority] that the information cannot be provided.

(6) The [F2licensing authority] must give the person giving the notification a notice stating reasons for its decision in any case where—

(a)the [F2licensing authority] refuses to include the person giving the notification on the list; or

(b)if the [F2licensing authority] lists the person giving the notification otherwise that in accordance with the information supplied in the notification.]

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