58.—(1) The licensing authority must take all reasonable steps to ensure that it makes a decision to grant or refuse a UK marketing authorisation before the end of 210 days beginning immediately after the day on which the application for the authorisation is submitted in accordance with regulations 49 to 55.
(2) If the licensing authority requests the applicant to provide any further information or material, the period referred to in paragraph (1) is suspended for the period—
(a)beginning with the date on which the request is made; and
(b)ending with the date on which the information or material is provided.
(3) If the licensing authority requests the applicant to give an oral or written explanation of the application, the period referred to in paragraph (1) is suspended for the period—
(a)beginning with the date on which the request is made; and
(b)ending with the date on which the explanation is provided.
(4) The licensing authority may grant the application only if, having considered the application and the accompanying material, the authority thinks that—
(a)the applicant has established the therapeutic efficacy of the product to which the application relates;
(b)the positive therapeutic effects of the product outweigh the risks to the health of patients or of the public associated with the product;
(c)the application and the accompanying material complies with regulations 49 to 55; and
(d)the product’s qualitative and quantitative composition is as described in the application and the accompanying material.
(5) Schedule 11 makes provision about advice and representations in relation to an application for the grant of a UK marketing authorisation.
(6) This regulation does not apply to an application that—
(a)has been submitted to the licensing authority in accordance with Article 28 of the 2001 Directive; or
(b)has been referred to the Committee for Medicinal Products for Human Use established under Regulation (EC) No 726/2004 for the application of the procedure laid down in Articles 32 to 34 of the 2001 Directive.
(7) An application to which paragraph (6) applies is to be determined by the licensing authority in accordance with Chapter 4 of Title III of the 2001 Directive.