The Medicines for Human Use (Marketing Authorisations Etc.) Amendment Regulations 2009

Amendment of paragraph 7 of Schedule 2 to the 1994 Regulations

2.  For paragraph 7 of Schedule 2 to the 1994 Regulations (requirement to consult the appropriate committee) substitute the following paragraph—

“7.— (1) The licensing authority shall not, at any time while this Schedule applies—

(a) unless the circumstances described in sub-paragraph (2) apply, refuse to grant or renew the authorization applied for; or

(b) revoke, vary or (subject to paragraph 12 of this Schedule) suspend an authorization,

on grounds relating to safety, quality or efficacy, except after consultation with the appropriate committee.

(2) The circumstances for the purposes of sub-paragraph (1)(a) are—

(a) the licensing authority has requested the applicant to supply information which the licensing authority regards as relevant to enable the application to be determined; and

(b) the information has not been supplied to the licensing authority within the relevant period.

(3) In sub-paragraph (2) the “relevant period” is—

(a) where the licensing authority has completed its initial full assessment of the application, the period of six months beginning with the date on which the licensing authority requested the applicant to supply the information referred to in sub-paragraph (2)(a); or

(b) where the licensing authority has completed its assessment of any supplemental information, the period of three months beginning with the date on which the licensing authority requested the applicant to supply the information referred to in sub-paragraph (2)(a).

(4) The applicant may at any time before the relevant period has expired submit a request to the licensing authority for the period to be extended.

(5) An applicant requesting an extension of the relevant period must provide grounds on which the request is made.

(6) Where an applicant has submitted a request in accordance with sub-paragraphs (4) and (5), the licensing authority may extend the relevant period in accordance with the request provided it considers that the grounds on which it is made are exceptional.”.