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

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unless paragraph (b) applies, the application is to be treated as withdrawn;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(i) must after all, be provided, the application is to be treated as withdrawn unless the information or documentation that must still be provided is provided within a new period reasonably specified by the NHSCB for the provision of that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(ii) need not be provided by the applicant, the request of the NHSCB is to be treated as withdrawn to the extent that it relates to information or documentation that need not be provided.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.