Paragraph 13 Outgoing mutual recognition applications

The fee payable under regulation 16 in connection with an application to the licensing authority for regulatory assistance in connection with obtaining recognition according to the procedure laid down in Title III, Chapter 4 of the 2001 Directive of a single United Kingdom marketing authorization in a concerned member State is—

(a)

if the application in the concerned member State, had it been in the United Kingdom, would have been a major application—

(i)

in respect of the first application for regulatory assistance to the licensing authority, a fee of £42,090, and

(ii)

in respect of each other application for regulatory assistance to the licensing authority, a fee of £27,648;

(b)

if the application in the concerned member State, had it been in the United Kingdom, would have been a complex application—

(i)

in respect of the first application for regulatory assistance to the licensing authority, a fee of £10,883, and

(ii)

in respect of each other application for regulatory assistance to the licensing authority, a fee of £7,221;

(c)

if the application in the concerned member State, had it been in the United Kingdom, would have been a standard application—

(i)

in respect of the first application for regulatory assistance to the licensing authority, a fee of £4,333, and

(ii)

in respect of each other application for regulatory assistance to the licensing authority, a fee of £3,611; and

(d)

if the application in the concerned member State, had it been in the United Kingdom, would have been a simple application, in respect of each application for regulatory assistance to the licensing authority, a fee of £2,593.