SCHEDULE 1CAPITAL FEES FOR APPLICATIONS FOR, AND VARIATIONS TO, MARKETING AUTHORIZATIONS, LICENCES AND CERTIFICATES
PART 5Capital Fees for Assessment of Labels and Leaflets
Interpretation29
In this Part—
a
“clinical particulars”, in relation to a medicinal product, means the clinical particulars contained in the Summary of Product Characteristics for that product as specified in paragraph 4 of Article 11 of the 2001 Directive;
b
the “BROMI labels and leaflets self-certification guidance” means the document entitled “Guidance on Changes to Labelling and Patient Information Leaflets For Self – Certification” published by the licensing authority on its website on 28th January 200843.
Single set of changes30
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.
More than one set of charges purposed31
1
This paragraph applies where more than one set of proposed changes falling within regulation 22(1) is submitted by the same marketing authorization holder at the same time and where—
a
the sets of proposed changes consist of identical changes to the labelling or package leaflets of products with the same active ingredient or combination of ingredients, dosage form and clinical particulars; or
b
the sets of proposed changes consist of identical changes to different versions of the labelling or package leaflet of the same product.
2
Where this paragraph applies, the fee payable under regulation 22(1) is —
a
in connection with the first set of proposed changes considered by the licensing authority, the appropriate amount specified in paragraph 30; and
b
in connection with each of the other sets of proposed changes, 50 per cent of that amount.