Applications relating to new combinations of active substances
This section has no associated Explanatory Memorandum
55.—(1) This paragraph applies to an application for a UK marketing authorisation for a relevant medicinal product that contains active substances that—
(a)have been used in medicinal products that have been the subject of a marketing authorisation under these Regulations, the 2001 Directive or Regulation (EC) No 726/2004; but
(b)have not been used in that combination for therapeutic purposes.
(2) The applicant must provide information in accordance with Article 10b of the 2001 Directive.