The Medicines (Products for Human Use) (Fees) Regulations 2012

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 a variation of the provisions of a certificate of registration which does not require, in the opinion of the licensing authority, medical, scientific or pharmaceutical assessment;

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 an application for the grant of a certificate of registration;

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 Homoeopathic Regulations;

means an application— (a) for— (a) a marketing authorization for a medicinal product in respect of which another person holds a marketing authorization;

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 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.

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;

has the meaning given in paragraph 5 of Schedule 2;

means for the purpose of— (a) regulation 12 and Part 2 of Schedule 2 (capital fees for Applications for Authorizations, Licences, Registrations and Certificates), 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 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 an application relating to a homoeopathic medicinal product in respect of which at the time of the application— (a) an EC registration has been granted in an 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 an application for a marketing authorization to which the third sub-paragraph of Article 10(1) of the 2001 Directive applies.

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

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 Marketing Authorisation Regulations applies, which was not manufactured in the United Kingdom and in relation to which no marketing authorization has been granted;

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 conditions and principles of good clinical practice specified in Schedule 1 to the Clinical Trials Regulations;

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 Guidelines on Good Distribution Practice of Medicinal Products for Human Use (94/C63/03) published by the European Commission pursuant to Article 84 of the 2001 Directive;

means the principles and guidelines of good manufacturing practice set out in Directive 2003/94/EC;

means the Guidelines on Pharmacovigilance for Medicinal Products for Human Use published by the European Commission pursuant to Article 106 of the 2001 Directive;

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 by any pharmacopoeia used officially in a Member State;

means the Medicines (Homoeopathic Medicinal Products for Human Use) Regulations 1994;

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— (a) where the medicinal product has not been manufactured or imported into the United Kingdom during the period of 12 months preceding the commencement of the relevant fee period;

has the meaning given in paragraph 10 of Schedule 2;

means an application for several variations to one marketing authorization and— (a) at least one of the variations relates to one or more of the changes referred to in paragraph 23 of Schedule 2;

means an application for several variations to one marketing authorization and— (a) at least one of the variations is a variation to a marketing authorization so that the medicinal product is indicated for a use referred to in paragraph 9(a) or (b) of Schedule 2;

means an application for several variations to one marketing authorization and— (a) at least one of the variations is a major variation of type II;

has the meaning given in Article 2(3) of EC Regulation No. 1234/2008;

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

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

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

includes any medicinal product for human use to which the 2001 Directive applies and any substance or article specified in any order for the time being in force made under section 104 (application of the Act to certain articles and substances) or 105(1)(a) (application of the Act to certain other substances which are not medicinal products) of the Act which directs that Part II of the Act or the Clinical Trials Regulations shall have effect in relation to such substance or article;

means an application for several variations to one marketing authorization and— (a) at least one of the variations is a minor variation of type IB;

has the meaning given in Article 2(2) of EC Regulation No. 1234/2008;

has the meaning given in Article 2(5) of EC Regulation No. 1234/2008;

means an application relating to a homoeopathic medicinal product in respect of which— (a) an EC registration has already been granted in another EEA State;

means the documents entitled “Guidance on changes to labelling and patient information for self-certification” and “Guidance on changes to labelling for self certification – compliance with article 56(a) – inclusion of Braille on the labelling” published by the licensing authority and available on its website.

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 33 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;

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 Marketing Authorisation 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 European Union law relating to parallel imports;

means a fee payable under regulation 49;

means the fee payable under regulation 33 or 34 by the holder of— (a) a marketing authorization (other than a European Union marketing authorization), a traditional herbal registration, a manufacturing authorisation, a manufacturer’s licence, a wholesale dealer’s 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 EU 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 Title II of Regulation (EC) No. 726/2004;

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 EU 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 falling within the meaning of section 7 of the Act;

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 EU 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 I to the 2001 Directive;

has the meaning given in paragraph 25(2).

means the periodic fee payable in relation to a prescription only medicine where the total value of the product which is sold or supplied in the relevant fee period does not exceed £35,000;

has the meaning given in Article 20(2)(b) of EC Regulation No. 1234/2008.

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 sub-paragraphs (a) to (c)— (a) the advice is in connection with a change to the dates for renewal of one or more EU marketing authorizations relating to a product range pursuant to Article 24 of the 2001 Directive;

means issues relating to the application of any EU instrument relating to EU 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, traditional herbal registration, 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 other than— (a) a traditional herbal medicinal product;

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;

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;

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— (a) a number of applications to the licensing authority for regulatory assistance in connection with obtaining recognition according to the procedure laid down in Articles 28 and 29(1) to (3) of the 2001 Directive of a single certificate of registration in other EEA States, where those applications to the licensing authority all relate to applications for EC certificates of registration in other EEA States that have the same 90 day assessment period for the purposes of Article 28(4) of the 2001 Directive;

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

means—

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 the periodic fee payable in relation to a prescription only medicine where the total value of the product which is sold or supplied in the relevant fee period exceeds £35,000;

means a variation of the provisions of a certificate of registration which, in the opinion of the licensing authority, requires medical, scientific or pharmaceutical assessment and which requires in respect of any homoeopathic medicinal products to which that certificate relates— (a) the replacement of an excipient used in the manufacture of the product with a comparable excipient;

means a certificate granted under Council Regulation (EC) No. 469/2009 concerning the creation of a supplementary protection certificate for medicinal products and a patent qualifies for the granting of such a certificate if the provisions of that Regulation so provide.

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 Advisory Board on the Registration of Homoeopathic Products;

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

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

means, the gross value at manufacturer’s prices of all medicinal products to which the authorization relates that are sold or supplied in the United Kingdom by the holder of that authorization during a period of 12 months preceding the commencement of the relevant fee period.

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 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 2(2) of EC Regulation No. 1234/2008.

means a marketing authorization granted by the licensing authority under the Marketing Authorisation 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.

means the work sharing procedure within the meaning of Article 20 of EC Regulation No. 1234/2008.