OpenLegislation

Paragraph 13 Application for the renewal of a marketing authorisation

Original text. Later amendments are not shown.

(1)

The fee for the renewal of a marketing authorisation issued after these Regulations come into force is £1,275.

(2)

In the case of a marketing authorisation issued before these Regulations come into force—

(a)

if it is the first time the marketing authorisation has been renewed the fee is £1,275; and otherwise £290;

(b)

if further assessment of post authorisation commitments is required the fee is £1,275.

(3)

The fee for the first reassessment of a provisional marketing authorisation is £290, and the fee for each subsequent reassessment is £1,275.