11.—(1) As regards any routine or excepted application, if the Primary Care Trust to which the application is made 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 Primary Care Trust in the request under paragraph (a)—
(i)provide any information or documentation reasonably requested,
(ii)notify the Primary Care Trust 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 Primary Care Trust of that and seek a review by the Primary Care Trust 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 Primary Care Trust under paragraph (1)(b), or
(ii)ending on the date specified by the applicant in accordance with paragraph (1)(b)(ii), if the Primary Care Trust 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unless paragraph (b) applies, the application is to be treated as withdrawn;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 Primary Care Trust 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(i)must after all, be provided, the application is to be treated as withdrawn unless the information or documentation that must still be provided is provided within a new period reasonably specified by the Primary Care Trust for the provision of that information or documentation,
(ii)need not be provided by the applicant, the request of the Primary Care Trust is to be treated as withdrawn to the extent that it relates to information or documentation that need not be provided.
(3) A Primary Care Trust 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.
12.—(1) If, when an applicant (A) submits an application, A fails to provide with the application the undertakings referred to in paragraph 9 that are relevant to the application, the Primary Care Trust must, prior to notifying the application under Part 3, request that A provide the relevant undertakings within a specified period.
(2) If A fails to comply with a request under sub-paragraph (1) within a period reasonably specified by the Primary Care Trust under that sub-paragraph, the application is to be treated as withdrawn.
13.—(1) Where an applicant (A) is relying on paragraph 5(1), the Primary Care Trust to which A’s application is made (PCT1) must notify A’s home Primary Care Trust (PCT2) of the application and seek a recommendation from it as to whether the application should be refused or deferred under regulation 33 or 34.
(2) Where it receives a notification under sub-paragraph (1), PCT2 must consider whether the application should be refused or deferred under regulation 33 or 34, and having done so, it must make a recommendation to PCT1 within 30 days of having received the notification.
(3) The recommendation must—
(a)set out all the relevant facts and be fully reasoned; and
(b)if it is that the application be refused or deferred, be sent by PCT1 as soon as is practicable to A, and PCT1 must at the same time seek the views of A on the accuracy of the facts set out by PCT2.
14.—(1) A Primary Care Trust that receives—
(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 Primary Care Trust 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 Primary Care Trust is required to treat it as withdrawn.
(3) Notification must not be delayed because of a deferral under regulation 34 in a case where the applicant is relying on paragraph 5(1), unless prior to the decision to defer the applicant’s home Primary Care Trust has provided PCT1 with its recommendation under paragraph 13(2).
15. A Primary Care Trust that receives 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.
16. A Primary Care Trust that receives 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).
17. A Primary Care Trust that receives 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).