Office of Public Sector Information
SCHEDULE 1 continued PART 5
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 28th January 2008(43).
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.
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.
32. Unless paragraph 33 applies, the fee payable under regulation 26(1) in connection with regulatory assistance provided by the United Kingdom acting as reference Member State where an application is made to the licensing authority for the renewal of a United Kingdom marketing authorization in relation to a medicinal product which has been subject to the procedures specified in regulation 26(2), is —
(a) £9,803, if the application for renewal relates to a medicinal product which, at the time the United Kingdom marketing authorization was granted, contained a new active ingredient and that renewal is the first renewal in relation to which the United Kingdom is to provide regulatory assistance acting as reference Member State; or
(b) £756, in any other case.
33.—(1) This paragraph applies if more than one application falling within regulation 26(1) is made by the same applicant at the same time, each of which relates to medicinal products which have the same active ingredient or combination of ingredients, dosage form, therapeutic indications and Periodic Safety Update Reports, and the United Kingdom marketing authorizations for those products have the same date for renewal.
(2) The fee payable under regulation 26(1) for applications to which sub-paragraph (1) applies is—
(a) if the applications fall within paragraph 32(a)—
(i) for the first application considered by the licensing authority, the amount specified in paragraph 32(a), and
(ii) £756, for each other application;
(b) if the applications fall within sub-paragraph (1) of paragraph 32(b)—
(i) for the first application considered by the licensing authority, the amount specified in paragraph 32(b), and
(ii) £378, for each other application.
Regulations 27(1), 30
1. In this Schedule—
(a) if an inspection is made at a site which is outside the United Kingdom, the fee for the inspection is increased by an amount equal to the travelling and subsistence costs of the inspector relating to the inspection and any additional costs (such as interpreters’ fees) reasonably incurred by him in respect of that inspection as a result of its being at a site outside the United Kingdom;
(b) for the purposes of paragraphs 3(1)(c), 4(1)(c) and 6(1)(c) in calculating the number of days taken to make an inspection, any part day shall be calculated as a whole day; and
(c) if an inspection is made by more than one inspector, the time taken by the licensing authority to make an inspection is the aggregate of times spent by each inspector in making the inspection.
2.—(1) The fee for an inspection made at a site is—
(a) £2,452, if the time taken to make the inspection is not more than 7 hours; and
(b) thereafter £1,226, for every additional period of 3 hours and 30 minutes or less taken to make the inspection.
(2) But sub-paragraph (1) does not apply if the inspection is one for which a fee is payable under paragraphs 3 to 7.
3.—(1) If this sub-paragraph applies, the fee payable in respect of an inspection of a site in connection with the grant, variation or renewal of a manufacturer’s licence or during the currency of such a licence, is—
(a) £920, if the time taken to make the inspection is not more than 3 hours;
(b) £1,496, if the time taken to make the inspection is more than 3 hours but not more than 1 day; and
(c) if the time taken to make the inspection is more than 1 day, the amount calculated by multiplying the total number of days taken to make the inspection by £1,496.
(2) Sub–paragraph (1) applies if the site inspected is wholly concerned with the manufacture, assembly or import from a third country of traditional herbal medicinal products.
4.—(1) If this sub-paragraph applies, the fee payable in respect of an inspection of an API manufacturer pursuant to Article 111(1)(a) of the 2001 Directive, is—
(a) £920, if the time taken to make the inspection is not more than 3 hours;
(b) £1,496, if the time taken to make the inspection is more than 3 hours but not more than 1day; and
(c) if the time taken to make the inspection is more than 1 day, the amount calculated by multiplying the total number of days to make the inspection by £1,496.
(2) Sub-paragraph (1) applies if the site inspected is wholly concerned with the manufacturer or assembly of starting material for use in the manufacture of traditional herbal medicinal products.
5. Except in the case of an inspection falling within paragraphs 6 or 7, the fee for an inspection of a site made in connection with the grant, variation or renewal of a wholesale dealer’s licence or during the currency of such a licence, is —
(a) £1,792, if the time taken to make the inspection is not more than 7 hours; and
(b) £896, for every subsequent period of 3 hours and 30 minutes or less taken to make the inspection.
6.—(1) If this sub-paragraph applies, the fee payable in respect of an inspection of a site in connection with the grant, variation or renewal of a wholesale dealer’s licence or during the currency of such a licence is—
(a) £690, if the time taken to make the inspection is not more than 3 hours;
(b) £1,266, if the time taken to make the inspection is more than 3 hours but not more than 1 day; and
(c) if the time taken to make the inspection is more than 1 day, the amount calculated by multiplying the total number of days taken to make the inspection by £1,266.
(2) Sub–paragraph (2) applies if the site inspected is wholly concerned with the manufacture, assembly or import from a third country of traditional herbal medicinal products.
7.—(1) If this sub-paragraph applies, the fee payable in respect of an inspection of a site made in connection with the grant, variation or renewal of a wholesale dealer’s licence is £896.
(2) Sub-paragraph (1) applies if the time taken to make the inspection is not more than 3 hours and 30 minutes; and
(a) the site is that of a wholesale dealer whose licence is limited to dealing only in medicinal products falling within a description or class specified in an Order made under section 51(1) (general sale lists) of the Act;
(b) the site relates to a registered pharmacy as referred to in paragraph 9(3) of Part 2 of Schedule 1; or
(c) the total turnover in respect of sales by way of wholesale dealing in authorised medicinal products of the wholesale dealer does not exceed £35,000.
(3) In paragraph (c) of sub–paragraph (2), “turnover” means the gross amount of the total sales made during the period of 12 months preceding the date of the application.
(4) But if the reason paragraph (c) of sub-paragraph (2) applies is because the applicant has not held a wholesale dealer’s licence during the 12 month period preceding the date of the application sub– paragraph (1) does not apply unless—
(a) at the time of making the application it is reasonable for the applicant to believe that the gross amount of total sales of authorised medicinal products likely to be made in the period of 12 months following the grant of the licence will not exceed £35,000; and
(b) he so informs the licensing authority when he makes his application.
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 info@mhra.gsi.gov.uk. Back [43]
The Medicines (Products for Human Use-fees) Regulations 2008