Paragraph 11 Application for a provisional marketing authorisationI1

United Kingdom

The fee for an application for a provisional marketing authorisation is the same as that for a full national marketing authorisation in paragraph 6 (in the case of a pharmaceutical product) or the fee for a national application in paragraph 8 (in the case of an immunological product), and the fee for its conversion into a full marketing authorisation is—

(a)

if the application for the full marketing authorisation is received within two years of the grant of the provisional marketing authorisation—

(i)

£8,130, or

(ii)

if the application for the provisional marketing authorisation was made before 1st October 2006, £10,705; and

(b)

in any other case the same fee as for the provisional marketing authorisation.

Annotations

Commencement

I1: Sch. 7 para. 11 in force at 1.10.2006, see reg. 1