OpenLegislation

Paragraph 30 Single set of changes

Original text. Later amendments are not shown.

(1)

Unless paragraph 31 applies, the fee payable under regulation 22(1) in connection with a set of proposed changes to the labelling or the package leaflet of a medicinal product is —

(a)

£524, in respect of a product which is the subject of a United Kingdom marketing authorization other than a parallel import licence; and

(b)

£332, in respect of a product which is the subject of a parallel import licence.

(2)

But if the proposed changes in respect of a product to which the fee in sub-paragraph (a) applies are submitted in accordance with the BROMI labels and leaflets self – certification procedure the fee payable under regulation 22(1) is £188.

(3)

For the purpose of this paragraph changes are submitted in accordance with the BROMI self -certification procedure if they are of a type described in the BROMI labels and leaflets self-certification guidance and comply with the conditions set out in relation to those changes in that guidance.