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11.—(1) As regards any routine or excepted application, if [F1NHS England] considers that relevant information or documentation is missing—
(a)it may request the missing relevant information or documentation from the applicant; and
(b)the applicant must, within the period reasonably specified by [F1NHS England] in the request under paragraph (a)—
(i)provide any information or documentation reasonably requested,
(ii)notify [F1NHS England] that there is to be a delay in providing the requested information or documentation, for specified reasons, and specify a date by which the applicant undertakes to provide the information or documentation, or
(iii)if the applicant considers that any information or documentation has been unreasonably requested, notify [F1NHS England] of that and seek a review by [F1NHS England] of the reasonableness of the request.
(2) If an applicant refuses to comply with a request under sub-paragraph (1)(a)—
(a)within the period—
(i)reasonably specified by [F1NHS England] under paragraph (1)(b), or
(ii)ending on the date specified by the applicant in accordance with paragraph (1)(b)(ii), if [F1NHS England] is satisfied that a delay beyond the period it specified, and the length of the delay, are for good cause,
unless paragraph (b) applies, the application is to be treated as withdrawn;
(b)in circumstances where the applicant has, in accordance with sub-paragraph (1)(b)(iii), sought a review by [F1NHS England] of the reasonableness of the request, if the review determines that any or all of the information or documentation requested—
(i)must after all, be provided, the application is to be treated as withdrawn unless the information or documentation that must still be provided is provided within a new period reasonably specified by [F1NHS England] for the provision of that information or documentation,
(ii)need not be provided by the applicant, the request of [F1NHS England] is to be treated as withdrawn to the extent that it relates to information or documentation that need not be provided.
(3) [F1NHS England] may request information or documentation under this paragraph at any time after it receives an application and before its determination of that application, but it must consider whether or not it needs to request information or documentation under this paragraph prior to notifying an application (where it is required to do so) under Part 3.
Textual Amendments
F1Words in Regulations substituted (6.11.2023) by The Health and Care Act 2022 (Further Consequential Amendments) (No. 2) Regulations 2023 (S.I. 2023/1071), reg. 1(1), Sch. para. 1
12.—(1) If, when an applicant (A) submits an application, A fails to provide with the application—
(a)the undertakings referred to in paragraph 9 that are relevant to the application, [F1NHS England] must, if the application is notifiable prior to notifying the application under Part 3, request that A provide the relevant undertakings within a specified period; or
(b)any fee payable in respect of that application by virtue of directions under section 131 of the 2006 Act (power to charge), [F1NHS England] must, if the application is notifiable prior to notifying the application under Part 3, request that A provide the fee (or any missing part of the fee) within a specified period.
(2) If A fails to comply with a request under sub-paragraph (1) within a period reasonably specified by [F1NHS England] under that sub-paragraph, the application is to be treated as withdrawn.
Textual Amendments
F1Words in Regulations substituted (6.11.2023) by The Health and Care Act 2022 (Further Consequential Amendments) (No. 2) Regulations 2023 (S.I. 2023/1071), reg. 1(1), Sch. para. 1
13. Where an applicant (A) is relying on paragraph 5(1), [F1NHS England] must ensure that the information that it holds about A is aggregated in such a way that it is able to make a reasonable determination as to whether the application should be refused or deferred under regulation 33 or 34.
Textual Amendments
F1Words in Regulations substituted (6.11.2023) by The Health and Care Act 2022 (Further Consequential Amendments) (No. 2) Regulations 2023 (S.I. 2023/1071), reg. 1(1), Sch. para. 1
F2Words in Sch. 2 para. 13 heading substituted (1.4.2014) by The National Health Service (Pharmaceutical and Local Pharmaceutical Services) (Amendment and Transitional Provision) Regulations 2014 (S.I. 2014/417), regs. 1, 17(b)
14.—(1) [F1NHS England], having received—
(a)a routine application, consideration of which may or must be deferred under regulation 14(1) to (3), 16(1) to (4), 19(1) to (4), 21(1) to (4) or 38(4); or
(b)a notifiable application, consideration of which may be deferred under regulation 32 or 34,
must consider, prior to notifying that application under Part 3 and as soon as is practicable, whether or not to defer consideration of that application under those provisions.
(2) If consideration of the application is deferred prior to notification, once [F1NHS England] no longer has grounds for deferring the application, it must proceed as soon as is practicable with the notification of the application, unless the application has been withdrawn or [F1NHS England] is required to treat it as withdrawn.
Textual Amendments
F1Words in Regulations substituted (6.11.2023) by The Health and Care Act 2022 (Further Consequential Amendments) (No. 2) Regulations 2023 (S.I. 2023/1071), reg. 1(1), Sch. para. 1
15. [F1NHS England], having received a notifiable application for inclusion in a pharmaceutical list from a person who is not already included in that list, may without notifying that application under Part 3 (or if no notification is required, as soon as is practicable) decide to refuse that application under regulation 30.
Textual Amendments
F1Words in Regulations substituted (6.11.2023) by The Health and Care Act 2022 (Further Consequential Amendments) (No. 2) Regulations 2023 (S.I. 2023/1071), reg. 1(1), Sch. para. 1
16. [F1NHS England], having received a notifiable application for inclusion in a pharmaceutical list from a person who is not already included in that list, may without notifying that application under Part 3 decide to refuse that application under regulation 33(1).
Textual Amendments
F1Words in Regulations substituted (6.11.2023) by The Health and Care Act 2022 (Further Consequential Amendments) (No. 2) Regulations 2023 (S.I. 2023/1071), reg. 1(1), Sch. para. 1
17. [F1NHS England], having received a routine application where the applicant is seeking the listing of pharmacy premises, must consider, prior to notifying that application under Part 3 and as soon as is practicable, whether or not the application needs to be refused under regulation 40(2).
Textual Amendments
F1Words in Regulations substituted (6.11.2023) by The Health and Care Act 2022 (Further Consequential Amendments) (No. 2) Regulations 2023 (S.I. 2023/1071), reg. 1(1), Sch. para. 1