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

means an ingredient of a medicinal product in respect of which efficacy is claimed (whether therapeutic, diagnostic or otherwise);

means an active ingredient in respect of which the application names as manufacturer a manufacturer not previously named as the manufacturer of that active ingredient included in a medicinal product in respect of which a marketing authorization (other than a product licence of right) or a traditional herbal registration has previously been granted;

means an application by a traditional herbal registration holder to vary a traditional herbal registration where the variation applied for falls within one of the following sub-paragraphs— (a) a change of either or both of the name and the address of the holder of the registration;

means a medicinal product prepared in accordance with the methods of anthroposophic medicine which is sold or supplied as an anthroposophic product and is so described by the person who sells or supplies that medicinal product;

means a medicinal product in respect of which a marketing authorization has been granted;

means any medicinal product derived from human blood or human plasma and includes albumin, coagulating factor and immunoglobulin of human origin;

means any fee, other than a periodic fee, payable under the provisions of these Regulations;

means a certificate for the purposes of the Medicines (Homoeopathic Medicinal Products for Human Use) Regulations 1994;

means an application— (a) for— (a) a marketing authorization for a medicinal product in respect of which another person holds a marketing authorization, (b) a manufacturing authorisation for activities in respect of which another person holds a manufacturing authorisation, (c) a traditional herbal registration for a medicinal product in respect of which another person holds a traditional herbal registration, (d) a manufacturer’s licence for activities in respect of which another person holds a manufacturer’s licence, or (e) a wholesale dealer’s licence for activities in respect of which another person holds a wholesale dealer’s licence;

means the conduct of studies of a medicinal product in human subjects in order to— (a) discover or verify the effects of such a product;

means any investigation in human subjects, other than a non-interventional trial, intended— (a) to discover or verify the clinical, pharmacological or other pharmacodynamic effects of one or more medicinal products;

means authorisation of the conduct of a clinical trial— (a) by the licensing authority in accordance with regulation 18 (authorisation procedure for clinical trials involving general medicinal products), 19 (authorisation procedure for clinical trials involving general medicinal products for gene therapy etc.) or 20 (authorisation procedure for clinical trials involving general medicinal products with special characteristics) of the Clinical Trials Regulations;

means the Medicines for Human Use (Clinical Trials) Regulations 2004;

means Commission Regulation (EC) No. 1084/2003 concerning the examination of variations to the terms of a marketing authorisation for medicinal products for human use and veterinary medicinal products granted by a competent authority of a Member State;

means a marketing authorization granted by the European Commission under Council Regulation (EEC) No. 2309/93 or Regulation (EC) No. 726/2004;

has the same meaning as in Schedule 1;

means an application for a traditional herbal registration relating to a medicinal product containing an active ingredient that has not previously been included as an active ingredient in a medicinal product in respect of which a marketing authorization (other than a product licence of right) or a traditional herbal registration has previously been granted;

means an application by a traditional herbal registration holder to vary a traditional herbal registration which relates to a change in the formulation of a medicinal product comprising one or more of the following changes— (a) a change in that product’s active ingredients which involves the addition of one or more active ingredients which are active ingredients from a new source;

means an EEA State, the competent authorities of which receive an application to obtain recognition, according to the procedure laid down in Title III, Chapter 4 of the 2001 Directive, of a United Kingdom marketing authorization;

means the conditions and principles specified in Schedule 1(conditions and principles of good clinical practice and for the protection of clinical trial subjects) to the Clinical Trials Regulations;

means a laboratory carrying out the examinations and tests referred to in— (a) paragraph 5A(2) of Schedule 2 (standard provisions for manufacturer’s licences and manufacturer’s licences of right) to the Medicines (Standard Provisions for Licences and Certificates) Regulations 1971;

means Council Regulation (EEC) No 2309/93 laying down Community procedures for the authorization and supervision of medicinal products for human and veterinary use and establishing a European Agency for the Evaluation of Medicinal Products;

means a major application, a complex application, a standard application or a simple application for a marketing authorization for a medicinal product in respect of which at the time of the application— (a) a marketing authorization has not been granted in any EEA State;

means Commission Directive 2003/94/EC laying down the principles and guidelines of good manufacturing practice in respect of medicinal products for human use and investigational medicinal products for human use;

means Council Directive 75/319/EEC on the approximation of provisions laid down by law, regulation or administrative action relating to medicinal products;

means Council Directive 93/42/EEC concerning medical devices;

means the electronic format of the Common Technical Document referred to in the guidance published by the European Commission in Volume 2B of “The Rules Governing Medicinal Products in the European Union”, referred to in paragraph (1) of the Introduction to Annex I to the 2001 Directive;

means an application made using the MHRA portal and in relation to which the accompanying particulars and documents are presented in eCTD format;

means an application for a marketing authorization to which the third sub-paragraph of Article 10(1) of the 2001 Directive applies;

means a medicinal product, as defined in Article 1(2) of the 2001 Directive, to which paragraph 1 of Schedule 1 (exemptions and exceptions from the provisions of regulation 3) to the 1994 Regulations applies, which was not manufactured in the United Kingdom and in relation to which no marketing authorization has been granted;

means an application by a marketing authorization holder to vary a marketing authorization (not being a parallel import licence) so that the medicinal product is indicated for use— (a) in a therapeutic area for which the product was not previously indicated for use;

means the period beginning with the first day of April in any year and ending with the last day of March in the following year;

means a medicinal product (not being an anthroposophic product, a herbal remedy or a homoeopathic medicinal product) of a description or falling within a class specified in an Order made under section 51(1) (general sale lists) of the Act;

means the non-statutory voluntary scheme of accreditation operated by the licensing authority in relation to Phase 1 trials which participants may join following satisfactory completion of a good clinical practice inspection;

means the Medicines (Traditional Herbal Medicinal Products for Human Use) Regulations 2005;

has the meaning given by Article 1(31) of the 2001 Directive;

means a marketing authorization granted by the licensing authority in respect of a national homoeopathic medicinal product;

means any medicinal product (which may contain a number of principles) prepared from substances called homoeopathic stocks in accordance with a homoeopathic manufacturing procedure described by the European Pharmacopoeia or, in the absence thereof, by any pharmacopoeia used officially in a member State;

means— (a) in relation to the formulation of the product, identical as regards the requirements in respect of composition, preparation and testing;

means any medicinal product which is a vaccine, toxin, serum or allergen product;

means the development by two or more applicants for marketing authorizations relating to medicinal products— (a) each of which contains the same new active ingredient or combination of new active ingredients but with different proprietary names and which does not require separate consideration by a committee established under section 4 (establishment of committees) of the Act or by the Commission;

means a medicinal product in respect of which an application for a marketing authorization has been submitted, to which point 6 of Part II of Annex I to the 2001 Directive applies or which is in respect of an orphan medicinal product;

means the periodic fee payable where the authorization holder has notified the licensing authority that the medicinal product to which the marketing authorization relates, being a prescription only medicine, a pharmacy medicine or a general sale list medicine, is not expected to be manufactured, or imported into the United Kingdom during the relevant fee period;

means an application for a marketing authorization relating to a medicinal product containing a new active ingredient;

means a manufacturing authorisation granted for the purposes of regulation 36 (requirement for authorisation to manufacture or import investigational medicinal products) of the Clinical Trials Regulations;

means, except in regulation 3— (a) a United Kingdom marketing authorization granted by the licensing authority under the 1994 Regulations;

has the same meaning as in Article 1(2)(a) of Directive 93/42/EEC;

includes a substance incorporated in a medical device which, if used separately, may be considered to be a medicinal product as defined in Article 1(2) of the 2001 Directive;

means a major application, a complex application, or a standard application for a marketing authorization for a medicinal product in respect of which— (a) a marketing authorization has already been granted in another EEA State;

means a homoeopathic medicinal product which – (a) does not satisfy the conditions set out in article 14(1) of the 2001 Directive;

means an active ingredient that has not previously been included as an active ingredient in a medicinal product in respect of which a marketing authorization (other than a product licence of right) has previously been granted;

means a medicinal product which is not a limited use drug and which contains an active ingredient which has not previously been included as an active ingredient in a medicinal product in respect of which a marketing authorization (other than a product licence of right) has been granted in the five years preceding 31st December in the fee period preceding the relevant fee period;

means— (a) except in Part 2, paragraph 11 and Part 4, any ingredient of a medicinal product, other than an active ingredient, that has not previously been included in a medicinal product— (a) which is intended to be administered by the same route of administration as the product in question, and (b) in respect of which a marketing authorization (other than a product licence or right), a certificate of registration or a traditional herbal registration has previously been granted, except that in the case of a medicinal product intended to be administered orally, the expression does not include any ingredient specified in any enactment (including an enactment comprised in subordinate legislation or in any Directive, Regulation or Decision of the European Community) as an approved ingredient or additive in food or in a food product;

means an application, other than a complex variation application, by a traditional herbal registration holder to vary a traditional herbal registration which relates to a change in the formulation of the medicinal product to add a new excipient;

means an application to vary a marketing authorization for a national homoeopathic product, so that product is indicated for a therapeutic use not previously covered by that authorization;

has the meaning given in article 2(b) of Regulation (EC) No. 141/2000 of the European Parliament and of the Council of 16th December 1999 on orphan medicinal products;

means a marketing authorization granted in respect of a medicinal product for human use which is not protected by a supplementary protection certificate or by a patent which qualifies for the granting of such a certificate, covering exclusively therapeutic indications which are relevant for use in the paediatric population, or subsets thereof, including the appropriate strength, pharmaceutical form or route of administration for that product;

means a United Kingdom marketing authorisation granted by the licensing authority under the 1994 Regulations in respect of a relevant medicinal product which is imported into the United Kingdom from another EEA State in accordance with the rules of Community law relating to parallel imports;

means a fee payable under regulation 41;

means the fee payable under regulation 31 or 32 by the holder of a marketing authorization (other than a Community marketing authorization), a traditional herbal registration, a manufacturing authorisation, a manufacturer’s licence, a wholesale dealer’s licence or a clinical trial authorisation for the holding of the authorization, registration, authorisation or licence;

means a report prepared to meet the requirements of the 2001 Directive;

means advice, other than scientific advice, which falls within one or more of the descriptions specified in paragraphs (a) and (b)— (a) the advice is in connection with an application for an EC marketing authorization, or is given with a view to a person making such an application, and relates to— (a) the obligations that would relate to the holder of such an authorization by virtue of Title IX of the 2001 Directive or Chapter 3 of the Title II of Regulation (EC) No. 726/2004, (b) the pharmacovigilance and risk-management systems that the applicant would be required to introduce in accordance with Article 8(3)(ia) of the 2001 Directive, or (c) a post-authorization safety study protocol;

means a medicinal product (not being an anthroposophic product, a herbal remedy or a homoeopathic medicinal product) which is neither a prescription only medicine nor a general sale list medicine;

means a clinical trial to study the pharmacology of a medicinal product when administered to humans, where the sponsor and investigator have no knowledge of any evidence that the product has effects likely to be beneficial to the subjects of the trial;

means a clinical trial, other than a Phase I trial, where the medicinal product being tested— (a) does not have an EC marketing authorization;

means a clinical trial other than a Phase I trial or a Phase II or Phase III trial;

means a document that describes the objectives, design, methodology, statistical considerations and organisation of a post-authorization safety study;

means a medicinal product (not being an anthroposophic product, a herbal remedy, a homoeopathic product, a new active substance or a derivative of a new active substance) of a description or falling within a class specified in an Order made under section 58(1) (medicinal products on prescription only) of the Act;

means— (a) that party to a joint development who first makes an application for a marketing authorization relating to a new active ingredient which was the subject of that joint development;

includes a series of products each of which is prepared from identical homoeopathic stocks;

means a product licence within the meaning of section 7 (general provisions as to dealing with medicinal products) of the Act which is a licence of right within the meaning of section 25(4) (entitlement to licence of right) of the Act;

means one or more medicinal products containing the same active substance in relation to which the same person holds more than one EC marketing authorization;

means the chemical, pharmaceutical and biological testing necessary to demonstrate the quality of a relevant medicinal product, in accordance with section 3 of Part 1 of Annex 1 to the 2001 Directive;

means an application for variation of a marketing authorization which has the effect that a medicinal product to which that authorization relates— (a) is to be available only from a pharmacy, where previously it was available only on prescription;

means the periodic fee payable where the turnover relating to a medicinal product being a prescription only medicine, a pharmacy medicine or a general sale list medicine, does not exceed £35,000 in the relevant calendar year;

means an application other than a complex registration application for a traditional herbal registration relating to a medicinal product which is presented in the form of a herbal tea;

means an application, other than a complex registration application, or a traditional herbal registration where the application falls within one of the descriptions specified in sub-paragraphs (a) to (d) as follows— (a) the application relates to a medicinal product which is presented in the form of a herbal tincture;

means Regulation (EC) No. 726/2004 of the European Parliament and of the Council laying down Community procedures for the authorisation and supervision of medicinal products for human and veterinary use and establishing a European Medicines Agency;

means advice, other than scientific advice, in relation to the requirements of the 2001 Directive or Regulation (EC) No. 726/2004 and which falls within one or more of the descriptions specified in paragraphs (a) to (c)— (a) the advice is in connection with a change to the dates for renewal of one or more EC marketing authorizations relating to a product range pursuant to Article 24 of the 2001 Directive;

means issues relating to the application of any Community instrument relating to EC marketing authorizations or to medical devices, or any enactment which implements such an instrument;

means any fee period during any part of which a marketing authorization, a traditional herbal registration, a clinical trial authorisation, manufacturing authorisation or licence in respect of which a periodic fee is payable is in force;

means a medicinal product for human use to which the provisions of the 2001 Directive apply;

means— (a) the formulation of a product which is identical to the formulation of another product— (a) in respect of which the applicant holds a certificate of registration or a homoeopathic marketing authorization, or (b) to which the applicant has, by the holder of the certificate of registration or the homoeopathic marketing authorization which relates to it, been authorised in writing to make reference for the purposes of this application;

means— (a) a homoeopathic stock which is identical to another homoeopathic stock which is used in the preparation of a product— (a) in respect of which the applicant holds a certificate of registration or a homoeopathic marketing authorization, or (b) in respect of which another person holds a certificate of registration or a homoeopathic marketing authorization to which, for the purposes of his application, the applicant has been authorised in writing to make reference by the person (or, if more than one, each of the persons) who supplied information to the licensing authority in connection with the application for the marketing authorization which relates to that product.

means any risk relating to the quality, safety or efficacy of a medicinal product as regards patients’ health or public health, or any risk of undesirable effects on the environment;

means the toxicological and pharmacological testing necessary to demonstrate the safety of a relevant medicinal product, in accordance with section 4 of Part 1 of Annex 1 to the 2001 Directive.

means advice in connection with the quality, safety or clinical development for a relevant medicinal product;

means any party to a joint development, other than the primary applicant, who makes an application for a marketing authorization relating to the same new active ingredient as that which was the subject of the application made by the primary applicant.

means—

means a number of proposed changes to the labelling or package leaflet of a medicinal product, where—

means— (a) an application for a marketing authorization to which Article 10c of the 2001 Directive applies;

means a written notice given to the licensing authority in accordance with paragraph 7(2) of Schedule 2 (standard provisions which may be incorporated in a manufacturer’s licence relating to the import of relevant medicinal products from a third country) to, or paragraph 3(2) of Schedule 4 (standard provisions which may be incorporated in a wholesale dealer’s licence) to, the Medicines for Human Use (Manufacturing, Wholesale Dealing and Miscellaneous Amendments) Regulations 2005;

means any application for the grant of a marketing authorization which is not a major application, a complex application, a simple application, a change of ownership application or an application for a parallel import licence;

means the periodic fee payable where the turnover relating to a medicinal product, being a prescription only medicine, a pharmacy medicine or a general sale list medicine, does exceed £35,000 in the relevant calendar year;

means any application for the grant of a traditional herbal registration which is not a complex registration application, a reduced registration application category I, a reduced registration application category II or a change of ownership application;

means an application by a traditional herbal registration holder to vary a traditional herbal registration which is not a complex variation application, a new excipient variation application or an administrative variation application;

means an application for a variation of a marketing authorization for a national homoeopathic medicinal product which requires— (a) the replacement of an excipient used in the manufacture of the product;

means a certificate granted under Council Regulation (EEC) No. 1768/92 concerning the creation of a supplementary protection certificate for medicinal productsand a patent qualifies for the granting of such a certificate if the provisions of that Regulation so provide.

means the Medicines for Human Use (Marketing Authorisations Etc) Regulations 1994;

means Directive 2001/83/EC of the European Parliament and of the Council on the Community code relating to medicinal products for human use;

means the Medicines Act 1968 and, except as provided below, expressions used in these Regulations have the same meaning as in the Act;

means the internet-based hosted platform which enables persons to carry out business with the Medicines and Healthcare products Regulatory Agency of the Department of Health electronically, known as the “the MHRA Portal”;

means the aggregate of all the periodic fees payable by a person in connection with all the authorizations, registrations, authorisations or licences held by that person.

has the meaning given by Article 1(29) of the 2001 Directive;

means a registration granted by the licensing authority under the Herbal Regulations;

means the gross amount of the total sales made during the period of 12 months preceding the date of the application.

means an application by a marketing authorization holder to vary a marketing authorization (not being a parallel import licence) which is a “minor variation” of Type IA within the meaning of Article 3.2 of Commission Regulation (EC) No. 1084/2003;

means an application by a marketing authorization holder to vary a marketing authorization (not being a parallel import licence) which is a “minor variation” of Type IB within the meaning of Article 3.2 of Commission Regulation (EC) No. 1084/2003;

means an application by a marketing authorization holder to vary a marketing authorization (not being a parallel import licence) which is not— (a) a reclassification variation;

means an application for a variation of a marketing authorization, other than an Extended Type II Complex Variation Application, which relates to a change— (a) in the formulation of a medicinal product comprising one or more of the following changes, other than a change to which paragraph 1 (changes to active substances) or paragraph 2 (changes to strength, pharmaceutical form and route of administration) of Annex II to Commission Regulation (EC) No. 1084/2003 applies— (a) a change which necessitates in- vivo bioavailability studies to be performed on that product, (b) a change in that product’s preservative system, or (c) a change in that product’s excipients which significantly affects the pharmaceutical or the therapeutic properties of that product;

means a marketing authorization granted by the licensing authority under the 1994 Regulations;

means a vitamin or mineral in respect of which the application names as manufacturer a manufacturer not previously named as the manufacturer of that vitamin or mineral included in a medicinal product in respect of which a marketing authorization (other than a product licence of right) or a traditional herbal registration has previously been granted.