The Medicines (Products for Human Use-Fees) Regulations 2008

PART 5 Capital Fees for Assessment of Labels and Leaflets

Interpretation

29.  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 28^th January 2008(1).

Single set of changes

30.—(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 purposed

31.—(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.

(1)

A copy of the guidance can be downloaded from the licensing authority’s website at www.mhra.gov.uk or obtained by writing to the licensing authority at Market Towers, 1 Nine Elms Lane, London SW8 5NQ or by sending an email to [e-mail].