Office of Public Sector Information
21. For the purposes of this Part and Part 5 of Schedule 1, a “set of proposed changes” means a number of proposed changes to the labelling or package leaflet of a medicinal product, where—
(a) if there is more than one version of the labelling or package leaflet for that product, those changes all relate to the same version; and
(b) those changes are submitted to the licensing authority at the same time.
22.—(1) Unless paragraph (2) or regulation 44 apply, where—
(a) a set of proposed changes to the labelling or the package leaflet of a medicinal product which is the subject of a United Kingdom marketing authorization (other than a parallel import licence) is submitted to the licensing authority in accordance with Article 61(3) of the 2001 Directive; or
(b) a set of proposed changes to the labelling or the package leaflet of a medicinal product which is the subject of a parallel import licence is submitted to the licensing authority,
the fee payable by the holder of that authorization or licence is the fee prescribed in Part 5 of Schedule 1 in connection with that change.
(2) Paragraph (1) does not apply where a change to the labelling or package leaflet of a medicinal product is proposed in connection with an application for the variation of the marketing authorization for that product.
23. Unless regulation 44 applies, all sums payable by way of fees under regulation 22 (1) must be paid at the time when the proposed changes are submitted to the licensing authority.
24.—(1) Unless regulation 44 applies, the fee payable by the applicant for an application to renew a manufacturer’s licence which falls within the description in paragraph (2) is £165.
(2) The licence referred to in paragraph (1) is one—
(a) which is solely for the manufacture of medicinal products the sale or supply of which does not require a marketing authorization or a product licence; and
(b) to which article 2(2)(i)(e) (exemptions for certain special manufactured products) of the Medicines (Exemption from Licences) (Special and Transitional Cases) Order 1971(30) applies.
(3) But if an inspection of a site is made in connection with the application an inspection fee of £273 is also payable by the applicant.
25. Where an applicant applies for renewal of a marketing authorization (other than a Community marketing authorization), a traditional herbal registration, a manufacturer’s licence or a wholesale dealer’s licence so as to contain provisions which are not identical to those in the authorization, registration or licence as in force at the date of the application, the fee payable under this Part of these Regulations is increased by an amount equal to the fee which would have been payable under Part 5 of these Regulations had he made a separate application for variation of that authorization, registration or licence in respect of each provision which is not identical.
26.—(1) Unless regulation 44 applies, where—
(a) an application is made to the licensing authority for the renewal of a United Kingdom marketing authorization for a medicinal product which has been subject to the procedures specified in paragraph (2); and
(b) the United Kingdom is to provide regulatory assistance acting as reference member State in relation to that application,
the fee payable by the applicant is the fee prescribed in Part 6 of Schedule 1 in connection with that regulatory assistance.
(2) The procedures referred to in paragraph (1) are—
(a) the procedures laid down in Articles 7 and 7a of Council Directive 65/65/EEC on the approximation of provisions laid down by law, regulation or administrative action relating to medicinal products(31) and in Articles 17 and 18 of the 2001 Directive;
(b) the procedures laid down in Article 9(4) of Directive 75/319/EEC and in Article 28 of the 2001 Directive;
(c) the procedures laid down in Articles 10 to 14 of Directive 75/319/EEC and in Articles 29 to 34 of the 2001 Directive;
(d) referral to the Committee for Propriety Medicinal Products in accordance with Council Directive 87/22/EEC on the approximation of national measures relating to the placing on the market of high-technology medicinal products, particularly those derived from biotechnology(32), if the opinion of the Committee in accordance with Article 4.1 of that Directive was given before 1st January 1995.
(3) For the purposes of this regulation and Part 6 of Schedule 1, the United Kingdom provides regulatory assistance acting as reference member State if—
(a) the licensing authority prepares or updates an assessment report in respect of the medicinal product to which the renewal application relates in order to make it available to the competent authorities of another EEA State; and
(b) an application to renew the marketing authorization relating to that product has been made in that other EEA State.
27.—(1) Unless regulation 44 or 48 applies, a fee in accordance with paragraphs 1 to 7 of Schedule 2 is payable for any inspection of a site made in connection with an application for, or during the currency of, a marketing authorization, a traditional herbal registration, a clinical trial authorisation, a manufacturing authorisation, a manufacturer’s licence or a wholesale dealer’s licence, except for an inspection for which a fee is payable under regulations 24 or 30.
(2) Unless regulation 28 or 29 applies, the fee in paragraph (1) is payable by the holder of or applicant for, as the case may be, the authorization, registration, authorisation or licence in relation to which the inspection is made.
28. Where an inspection is made of a contract laboratory or a site used by an API manufacturer the fee is payable by the operator of that laboratory, or, as the case may be, that API manufacturer.
29.—(1) Where an inspection is made outside the United Kingdom at a site which is named as a possible site for the manufacture or assembly of a medicinal product, or for the preparation of a substance which is to be used in the manufacture of an immunological product or a blood product—
(a) in more than one marketing authorization, clinical trial authorisation, traditional herbal registration; or
(b) by more than one applicant for such an authorisation or licence,
the fee for the inspection referred to in regulation 27(1) is payable in equal proportions by the holders of, or as the case may be, applicants for, the authorization, authorisation, licence or registration.
(2) In paragraph (1), the reference to an applicant for a clinical trial authorisation is a reference to a person who sends a valid notice of amendment as mentioned in regulation 19(1).
(3) Where an inspection is made in the United Kingdom at a site which is named as a possible site for the manufacture or assembly of a medicinal product, or the preparation of a substance which is to be used in the manufacture of an immunological product or a blood product—
(a) in more than one manufacturer’s licence or manufacturing authorisation; or
(b) by more than one applicant for such a licence or authorisation,
the fee for the inspection referred to in regulation 27(1) is payable in equal proportions by each applicant.
(4) But this regulation does not apply if the inspection is made of a contract laboratory or a site used by an API manufacturer.
30. Unless regulation 44 applies a fee in accordance with paragraphs 2 and 3 of Schedule 2 is payable by a person in respect of an inspection of one or more sites for the purpose of ascertaining whether that person—
(a) is—
(i) conducting, or has conducted, a clinical trial, or
(ii) performing, or has performed, the functions of a sponsor of a clinical trial (whether that person is the sponsor or is acting under arrangements made with that sponsor),
in accordance with the conditions and principles of good clinical practice, pursuant to regulation 28(1) (good clinical practice and protection of clinical trial subjects) of the Clinical Trials Regulations; or
(b) has put and kept in place arrangements for the purpose of ensuring that with regard to a clinical trial the conditions and principles of good clinical practice are satisfied or adhered to, pursuant to regulation 28(2) of those Regulations.
S.I. 1971/1450; amendments which are not relevant have been made to article 2. Back [30]
OJ No. L 22, 9.2.1965, p 369. This Directive has been codified an assembled with other into Directive 2001/83/EC. Back [31]
The Medicines (Products for Human Use-fees) Regulations 2008