- active ingredient
means an ingredient of a medicinal product in respect of which efficacy is claimed (whether therapeutic, diagnostic or otherwise);
- active ingredient from a new source
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 authorisation (other than a product licence of right) or a traditional herbal registration has previously been granted;
- active substance
means any substance or mixture of substances intended to be used in the manufacture of a medicinal product and that, when used in its production, becomes an active ingredient of that product intended to exert a pharmacological, immunological or metabolic action with a view to restoring, correcting or modifying physiological functions or to make a medical diagnosis;
- active substance registration
means the registration required by importers, manufacturers and distributors of active substances under article 52a of the 2001 Directive;
- administrative variation
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;
- Annex I to the 2001 Directive
has the meaning given by regulation 8(1) of the Human Medicines Regulations;
- anthroposophic product
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;
- application
means an application for the grant of a certificate of registration;
- assessor day
means— (a) in the case of an assessor who is a member of the senior civil service, one assessor working for one day;
- authorised medicinal product
means a medicinal product in respect of which a marketing authorisation has been granted;
- biological medicinal product
has the meaning given in paragraph 3.2.1.1.(b) of Part I of Annex I to the 2001 Directive;
- blood product
means any medicinal product derived from human blood or human plasma and includes albumin, coagulating factor and immunoglobulin of human origin;
- British Pharmacopoeia Commission
means the committee called the British Pharmacopoeia Commission carrying out functions under regulation 11 (British Pharmacopoeia Commission) of the Human Medicines Regulations;
- capital fee
means any fee, other than a periodic fee, payable under the provisions of these Regulations;
- certificate of registration
means a certificate for the purposes of Part 6 of the Human Medicines Regulations;
- change of ownership application
means an application— (a) for— (i) a marketing authorisation for a medicinal product in respect of which another person holds a marketing authorisation;
- clinical development
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;
- clinical particulars
means the clinical particulars contained in the Summary of Product Characteristics for that product as specified in of Article 11 of the 2001 Directive.
- clinical trial
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;
- clinical trial authorisation
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;
- Clinical Trials Regulations
means the Medicines for Human Use (Clinical Trials) Regulations 2004;
- Commission on Human Medicines
means the Commission on Human Medicines established under regulation 9 of the Human Medicines Regulations;
- Commission Regulation (EC) No 1234/2008
means Commission Regulation (EC) No 1234/2008 concerning the examination of variations to the terms of marketing authorisations for medicinal products for human use and veterinary medicinal products;
- complex application
has the meaning given in paragraph 5 of Schedule 2;
- concerned member State
means for the purpose of— (a) regulation 12 and Part 2 of Schedule 2 (capital fees for applications for authorisations, licences, registrations and certificates), an EEA State, the competent authority of which receives 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 authorisation;
- contract laboratory
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;
- converted EU marketing authorisation
has the meaning given in paragraph 6(1) and (2) of Schedule 33A to the 2012 Regulations.
- day
means a period of 8 hours and 30 minutes.
- day 120
means the day during the assessment of an application for a European Union marketing authorisation on which the Committee for Medicinal Products for Human Use adopts the list of questions, as well as the overall conclusions and review of the scientific data, to be sent to the applicant.
- decentralised procedure application
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;
- Directive 2003/94/EC
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;
- Directive 75/319/EEC
means Council Directive 75/319/EEC on the approximation of provisions laid down by law, regulation or administrative action relating to medicinal products;
- Early Access to Medicines Scheme
has the meaning given in regulation 8(1) of the Human Medicines Regulations;
- European reference product application
means an application for a marketing authorisation to which the third sub-paragraph of Article 10(1) of the 2001 Directive applies.
- European Union marketing authorisation
means a marketing authorisation granted by the European Commission under Council Regulation (EEC) No. 2309/93 or Regulation (EC) No 726/2004;
- extension
has the meaning given in paragraph 1 of Schedule 10A to the Human Medicines Regulations.
- fee period
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;
- general sale list medicine
means a medicinal product (not being an anthroposophic product, a herbal remedy or a homoeopathic medicinal product) classified as subject to general sale within the meaning of regulation 5(1) of the Human Medicines Regulations;
- good clinical practice
means the conditions and principles of good clinical practice specified in Schedule 1 to the Clinical Trials Regulations;
- good clinical practice accreditation scheme
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;
- good distribution practice
means the guidelines on good distribution practice published by the European Commission in accordance with Article 84 of the 2001 Directive;
- good manufacturing practice
means the principles and guidelines of good manufacturing practice set out in Directive 2003/94/EC;
- good pharmacovigilance practice
means the Guidelines on Pharmacovigilance for Medicinal Products for Human Use published by the European Commission under Article 108a of the 2001 Directive;
- herbal substances
has the meaning given by Article 1(31) of the 2001 Directive;
- homoeopathic marketing authorisation
means a marketing authorisation granted by the licensing authority in respect of a national homoeopathic medicinal product;
- 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;
- Human Medicines Regulations
means the Human Medicines Regulations 2012. • “immunological product” means any medicinal product which is a vaccine, toxin, serum or allergen product;
- identical
means— (a) in relation to the formulation of the product, identical as regards the requirements in respect of composition, preparation and testing;
- immunological product
means any medicinal product which is a vaccine, toxin, serum or allergen product;
- joint development
means the development by two or more applicants for marketing authorisations 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 the Commission on Human Medicines, the Herbal Medicines Advisory Committee or the Advisory Board on the Registration of Homoeopathic Products;
- limited use drug
means a medicinal product in respect of which an application for a marketing authorisation has been submitted, to which point 6 of Part II of Annex I to the 2001 Directive applies or in respect of which an orphan marketing authorisation has been granted;
- lower fee
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;
- major application
has the meaning given in paragraph 10 of Schedule 2;
- Major Variation (Type II) Complex Group Application
means an application for several variations to one marketing authorisation and— (a) at least one of the variations relates to one or more of the changes referred to in paragraph 23 of Schedule 2;
- Major Variation (Type II) Extended Complex Group Application
means an application for several variations to one marketing authorisation and— (a) at least one of the variations is a variation to a marketing authorisation so that the medicinal product is indicated for a use referred to in paragraph 9(a) or (b) of Schedule 2;
- Major Variation (Type II) Group Application
means an application for several variations to one marketing authorisation and— (a) at least one of the variations is a major variation of type II;
- manufacturing authorisation
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;
- marketing authorisation
means, except in regulation 3, an authorisation relating to a medicinal product for human use that is— (a) a United Kingdom marketing authorisation granted by the licensing authority under Part 5 (marketing authorisations) of the Human Medicines Regulations (and a reference to a UKMA(GB), UKMA(NI) or UKMA(UK) should be construed in accordance with those Regulations);
- medicinal product
has the meaning given by regulation 2 of the Human Medicines Regulations and includes any substance or article specified in any order for the time being in force made under section 104 (application of the 2012 Regulations to certain articles and substances) or 105(1)(a) (application of the 2012 Regulations to certain other substances which are not medicinal products) of the Act which directs that the Human Medicines Regulations or the Clinical Trials Regulations shall have effect in relation to such substance or article;
- Minor Variation (Type IB) Group Application
means an application for several variations to one marketing authorisation and— (a) at least one of the variations is a minor variation of type IB;
- mutual recognition procedure incoming application
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;
- National Guidance on labelling and patient information leaflets for self-certification
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) of the 2001 Directive – inclusion of Braille on the labelling” published by the licensing authority and available on its website.
- national homoeopathic product
means a homoeopathic medicinal product which— (a) does not satisfy the conditions set out in Article 14(1) of the 2001 Directive;
- new active ingredient
means an active ingredient that has not previously been included as an active ingredient in a medicinal product in respect of which a marketing authorisation (other than a product licence of right) has previously been granted;
- new active substance
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 authorisation (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;
- new excipient
means— (a) except in Part 2, paragraph 35 and Part 4, any ingredient of a medicinal product, other than an active ingredient, that has not previously been included in a medicinal product— (i) which is intended to be administered by the same route of administration as the product in question;
- orphan marketing authorisation
has the meaning given by regulation 8(1) of the Human Medicines Regulations;
- paediatric use marketing authorisation
means a marketing authorisation 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;
- parallel import licence
means a licence that— (a) is granted by the licensing authority in compliance with the rules of European Union law relating to parallel imports;
- penalty fee
means a fee payable under regulation 54;
- periodic fee
means the fee payable under— (a) regulation 38 by the holder of a marketing authorisation (other than a European Union marketing authorisation), a traditional herbal registration, a manufacturing authorisation, a manufacturer's licence or a wholesale dealer's licence;
- Periodic Safety Update Report
means a report prepared to meet the requirements of the 2001 Directive;
- pharmacovigilance advice
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 authorisation, or is given with a view to a person making such an application, and relates to— (i) the obligations that would relate to the holder of such an authorisation by virtue of Title IX of the 2001 Directive or Chapter 3 of Title II of Regulation (EC) No 726/2004;
- pharmacovigilance service provider
means a provider of pharmacovigilance services to a marketing authorisation holder.
- pharmacy medicine
means a medicinal product (not being an anthroposophic product, a herbal remedy or a homoeopathic medicinal product) classified as a pharmacy medicine within the meaning of regulation 5(5) of the Human Medicines Regulations;
- Phase I trial
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;
- Phase II or Phase III trial
means a clinical trial, other than a Phase I trial, where the medicinal product being tested— (a) does not have an EU marketing authorisation;
- Phase IV trial
means a clinical trial other than a Phase I trial or a Phase II or Phase III trial;
- post-authorisation safety study protocol
means a document that describes the objectives, design, methodology, statistical considerations and organisation of a post-authorisation safety study;
- prescription only medicine
means a medicinal product (not being an anthroposophic product, a herbal remedy, a homoeopathic medicinal product, a new active substance or a derivative of a new active substance) classified as a prescription only medicine within the meaning of regulation 5(3) of the Human Medicines Regulations;
- primary applicant
means— (a) that party to a joint development who first makes an application for a marketing authorisation relating to a new active ingredient which was the subject of that joint development;
- product
includes a series of products each of which is prepared from identical homoeopathic stocks;
- product licence
means a product licence within the meaning of paragraph 2(1) (product licences) of Schedule 32 to the Human Medicines Regulations;
- product licence of right
means a product licence within the meaning of paragraph 3(2) (product licences of right) of Schedule 32 to the Human Medicines Regulations;
- product range
means one or more medicinal products containing the same active substance in relation to which the same person holds more than one EU marketing authorisation;
- Promising Innovative Medicines designation
means a designation issued by the licensing authority under the Early Access to Medicines Scheme in accordance with regulation 167C(2)(a) of the Human Medicines Regulations;
- quality development
means the chemical, pharmaceutical and biological testing necessary to demonstrate the quality of a relevant medicinal product, in accordance with module 3 of Part 1 of Annex I to the 2001 Directive;
- reclassification element
has the meaning given in paragraph 25(2).
- reduced rate fee
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;
- reference authority
has the meaning given in Article 20(2)(b) of Commission Regulation (EC) No 1234/2008.
- Regulation (EC) No 726/2004
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;
- regulatory advice
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 authorisations relating to a product range under Article 24 of the 2001 Directive;
- relevant fee period
means any fee period during any part of which a marketing authorisation, traditional herbal registration, clinical trial authorisation, manufacturing authorisation or licence in respect of which a periodic fee is payable is in force;
- relevant medicinal product
means a medicinal product for human use to which the provisions of the 2001 Directive apply other than— (a) a traditional herbal medicinal product;
- repeat formulation
means— (a) the formulation of a product which is identical to the formulation of another product— (i) in respect of which the applicant holds a certificate of registration or a homoeopathic marketing authorisation;
- repeat stock
means— (a) a homoeopathic stock which is identical to another homoeopathic stock which is used in the preparation of a product— (i) in respect of which the applicant holds a certificate of registration or a homoeopathic marketing authorisation;
- safety development
means the toxicological and pharmacological testing necessary to demonstrate the safety of a relevant medicinal product, in accordance with module 4 of Part 1 of Annex 1 to the 2001 Directive;
- scientific advice
means advice in connection with the quality, safety or clinical development for a relevant medicinal product;
- scientific or other advice
includes— (a) scientific advice on an application for an EU marketing authorisation, or an application for the variation of an EU marketing authorisation, in relation to a medicinal product;
- secondary applicant
means any party to a joint development, other than the primary applicant, who makes an application for a marketing authorisation relating to the same new active ingredient as that which was the subject of the application made by the primary applicant.
- set of applications
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;
- set of proposed changes
means a number of proposed changes to the labelling or package leaflet of a medicinal product, where—
- similar
means—
- special import notice
means a written notice given to the licensing authority in accordance with paragraph 22(2) (manufacturer's licence relating to the import of medicinal products from a state other than an EEA State) of or, paragraph 34 (wholesale dealer's licence relating to special medical imports) of Schedule 4 to the Human Medicines Regulations. • “special medicinal product” means a product within the meaning of regulation 167 of the Human Medicines Regulations or any equivalent legislation in an EEA State other than the United Kingdom;
- special medicinal product
means a product within the meaning of regulation 167 of the Human Medicines Regulations or any equivalent legislation in an EEA State other than the United Kingdom;
- standard fee
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;
- standard period
means—
- standard variation
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;
- supplementary protection certificate
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.
- the 2001 Directive
means Directive 2001/83/EC of the European Parliament and of the Council on the Community code relating to medicinal products for human use;
- the Act
means the Medicines Act 1968 and, except as provided below, expressions used in these Regulations have the same meaning as in the Act;
- the Committee for Medicinal Products for Human Use
means the committee established under Article 5(1) of Regulation (EC) No 726/2004;
- the EMA
means the European Medicines Agency established by Regulation (EC) No 726/2004;
- the list of online sellers of medicines
has the same meaning as that given to “the list” by regulation 256A of the Human Medicines Regulations;
- the MHRA portal
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 and Social Care electronically, known as the “the MHRA Portal”;
- total unpaid fee
means the total of all the periodic fees payable by a person in connection with all the authorisations, registrations or licences held by that person.
- total value
means the gross amount of the total sales made during the period of 12 months preceding the date of the application;
- total value of the product
means the amount calculated in accordance with Part 2 of this Schedule.
- traditional herbal medicinal product
has the meaning given by Article 1(29) of the 2001 Directive;
- traditional herbal registration
means a traditional herbal registration granted by the licensing authority under Part 7 of the Human Medicines Regulations;
- Type IA Application
means an application by a marketing authorisation holder to vary a marketing authorisation (not being a parallel import licence) which is a “minor variation of type IA” within the meaning of
- under the unfettered access route
has the meaning given by regulation 8(1) of the Human Medicines Regulations;
- United Kingdom marketing authorisation
means a marketing authorisation granted by the licensing authority under— (a) Part 5 of the Human Medicines Regulations;
- vitamin or mineral from a new source
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 authorisation (other than a product licence of right) or a traditional herbal registration has previously been granted.
- work sharing
means, in the case of a UKMA(NI) or UKMA(UK), the work sharing procedure within the meaning of Article 20 of Commission Regulation (EC) No 1234/2008.