The National Health Service (Pharmaceutical and Local Pharmaceutical Services) Regulations 2013

PART 2 Preliminary matters

Relevant information or documentation

11.—(1) As regards any routine or excepted application, if the NHSCB 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 the NHSCB in the request under paragraph (a)—

(i) provide any information or documentation reasonably requested,

(ii) notify the NHSCB 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 the NHSCB of that and seek a review by the NHSCB 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 the NHSCB under paragraph (1)(b), or

(ii) ending on the date specified by the applicant in accordance with paragraph (1)(b)(ii), if the NHSCB 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unless paragraph (b) applies, the application is to be treated as withdrawn;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 the NHSCB 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(i) must after all, be provided, the application is to be treated as withdrawn unless the information or documentation that must still be provided is provided within a new period reasonably specified by the NHSCB for the provision of that information or documentation,

(ii) need not be provided by the applicant, the request of the NHSCB is to be treated as withdrawn to the extent that it relates to information or documentation that need not be provided.

(3) The NHSCB 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.

Failure to provide undertakings or fees

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, the NHSCB 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), the NHSCB 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 the NHSCB under that sub-paragraph, the application is to be treated as withdrawn.

Functions of the NHSCB in relation to fitness information relevant to applications from bodies corporate

13.  Where an applicant (A) is relying on paragraph 5(1), the NHSCB 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.

Deferral of notifiable applications prior to notification

14.—(1) The NHSCB, 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 the NHSCB 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 the NHSCB is required to treat it as withdrawn.

Refusal of notifiable applications prior to notification because of the language requirement for some NHS pharmacists

15.  The NHSCB, 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.

Refusal of notifiable applications on fitness grounds prior to notification

16.  The NHSCB, 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).

Proposed new pharmacy premises in controlled localities: refusal of routine applications because of preliminary matters prior to notification

17.  The NHSCB, 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).