New products
3.—(1) Where a presentation does not have a reference price as defined in regulation 2(2), the Secretary of State may specify the maximum price at which that presentation may be supplied for the purposes of the health service by a direction to a specific manufacturer or supplier.
(2) The maximum price for a presentation to which this regulation applies shall be determined by the Secretary of State having regard, among other things, to the following criteria—
(a)the expected supplies of the presentation for health service purposes;
(b)the cost of therapeutically equivalent medicines;
(c)the cost of the presentation in other markets if it is available elsewhere in the world;
(d)the cost of manufacture of the presentation;
(e)the cost of research into, and development of, the presentation;
(f)whether the presentation consists of or contains a new active substance; and
(g)the likelihood of the presentation being supplied at a particular price.