{
  "url": "https://openlegislation.uk/medicines-products-for-human-use-fees-regulations-2008/schedule-1/paragraph-14",
  "json_url": "https://openlegislation.uk/medicines-products-for-human-use-fees-regulations-2008/schedule-1/paragraph-14.json",
  "legislation": "uksi/2008/552",
  "legislation_title": "The Medicines (Products for Human Use-Fees) Regulations 2008",
  "legislation_url": "https://openlegislation.uk/medicines-products-for-human-use-fees-regulations-2008",
  "path": "schedule/1/paragraph/14",
  "kind": "paragraph",
  "number": "14",
  "heading": "Interpretation",
  "text": "In this Part of this Schedule—\n“administrative variation application” 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—\n(a) a change of either or both of the name and the address of the holder of the registration;\n(b) a change of either or both of the name and the address of a manufacturer, assembler, storer or distributor named in the registration where the change has been occasioned by the taking over of an existing business, whether by purchase, merger or otherwise, and any change of address does not involve a change of the site of manufacture, assembly or storage or of the site from which distribution takes place;\n(c) the removal from the registration of details of one or more of the sites of manufacture, assembly or storage or of the sites from which distribution takes place;\n“BROMI variation” means a notification of, or an application for, a variation to the terms of a marketing authorization which is not within the subject matter or scope of Commission Regulation (EC) No.1084/2003 and which—\n(a) is submitted using the MHRA portal;\n(b) is for a change set out in the BROMI variations guidance;\n(c) complies with the conditions to be fulfilled set out in the check list which relates to that change in the BROMI variations guidance; and\n(d) is accompanied by the documents which the BROMI variations guidance specifies must be provided with the application for the change;\n“BROMI self-certification variation” means a BROMI variation for a change which is designated a Self Certification Procedure type in the check list in the BROMI variations guidance;\n“BROMI Type IA variation” means a BROMI variation for a change which is designated a IA Procedure type in the check list in the BROMI variations guidance;\n“BROMI Type IB variation” means a BROMI variation for a change which is designated a IB Procedure type in the check list in the BROMI variations guidance;\n“BROMI variations guidance” means version 2.1 of the document published by the licensing authority on its website in February 2008, entitled “BROMI Dossier Requirements For Type IA And Type IB UK National Notifications” and dated November 2007;\n“complex variation application” 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—\n(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;\n(b) a change in that product’s excipients which involves the addition of one or more TSE risk excipients from a new source; or\n(c) a change which involves the addition of one or more vitamins or minerals which are vitamins or minerals from a new source where no European Pharmacopoeia certificate of suitability covering those vitamins or minerals has been submitted with the application;\n“Extended Type II Complex Variation Application” 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—\n(a) in a therapeutic area for which the product was not previously indicated for use; or\n(b) in respect of an organ, or any other part, of the human body for which the product was not previously indicated for use, if the application is supported by data which comprises or includes the results of clinical trials or physico-chemical, microbiological or pharmacological and toxicological tests;\n“new excipient variation application” 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;\n“new indication variation application” 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;\n“reclassification variation application” means an application for variation of a marketing authorization which has the effect that a medicinal product to which that authorization relates—\n(a) is to be available only from a pharmacy, where previously it was available only on prescription; or\n(b) is to be available on general sale, where previously it was available only on prescription or only from a pharmacy;\n“standard variation 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;\n“standard variation application for a homoeopathic product” means an application for a variation of a marketing authorization for a national homoeopathic medicinal product which requires—\n(a) the replacement of an excipient used in the manufacture of the product;\n(b) the replacement of a reagent indirectly associated with the manufacturing process of the product or which disappears from that process with a comparable reagent;\n(c) a change to the qualitative composition of the container or other form of packaging immediately in contact with the product;\n(d) a change to the method of manufacture of a homoeopathic stock included in the product;\n(e) a change to the specification of any reagent of excipient used in the manufacture of the product;\n(f) a change to the finished product specification of the product;\n(g) a change to the test procedure for any raw material used in the manufacture of the product;\n(h) a change to the test procedure for the product;\n(i) a change to the test procedure for the container or other form of packaging immediately in contact with the product;\n(j) a change to comply with a supplement to the European Pharmacopoeia or any national pharmacopoeia of a member State;\n(k) a change to the shape of the container in which the product may be placed on the market;\n(l) an additional pack size in which the product may be placed on the market;\n(m) a change to the approved storage conditions for the product;\n(n) a change to the shelf life of an unopened container of the product after the container has been opened for the first time;\n(o) a change to the dimensions of an approved dosage form of the product (for example, tablets); or\n(p) a change following modification to the manufacturing authorization referred to in Article 40 of the 2001 Directive;\n“Type IA 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;\n“Type IB 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 IB within the meaning of Article 3.2 of Commission Regulation (EC) No. 1084/2003;\n“Type II Application” means an application by a marketing authorization holder to vary a marketing authorization (not being a parallel import licence) which is not—\n(a) a reclassification variation;\n(b) a Type IA Application;\n(c) a Type IB Application;\n(d) a Type II Complex Variation Application;\n(e) an Extended Type II Complex Variation Application; or\n(f) a change to which Annex II to Commission Regulation (EC) No. 1084/2003 applies;\n“Type II Complex Variation Application” means an application for a variation of a marketing authorization, other than an Extended Type II Complex Variation Application, which relates to a change—\n(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—\n(i) a change which necessitates in- vivo bioavailability studies to be performed on that product,\n(ii) a change in that product’s preservative system, or\n(iii) a change in that product’s excipients which significantly affects the pharmaceutical or the therapeutic properties of that product; or\n(b) which is considered a “major variation” within the meaning given in Article 3.3 of Commission Regulation (EC) No. 1084/2003 and which is—\n(i) supported by data which comprises or includes the results of clinical trials or physicochemical, biological, microbiological or pharmacological and toxicological tests, or\n(ii) accompanied by evidence relating to post-marketing experience which is information of any type described in paragraph 5.2.6 of Part I of Annex I to the 2001 Directive (clinical documentation); or\n(c) in the composition, manufacture or use of a medicinal product to which—\n(i) paragraph (c), (e), (g), (h), (j) or (n) of the definition of complex application in this Schedule would apply where an application for a marketing authorization is made in respect of a medicinal product, or\n(ii) paragraph (i) of that definition would so apply and the change is not a variation which satisfies conditions 1, 3 and 4 specified in point 14 of Annex I to Commission Regulation (EC) No. 1084/2003 (change in the manufacturer of the active substance or starting material/reagent/intermediate in the manufacturing process of the active substance where no European Pharmacopoeia certificate of suitability is available).",
  "extent": null,
  "status": null,
  "version": "current",
  "annotations": [
    {
      "type": "footnote",
      "label": "f1",
      "text": "A copy of the guidance may be downloaded from the website at www. mhra. gov.uk or may be 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."
    }
  ],
  "outstanding_effects": [],
  "provenance": {
    "source": "legislation.gov.uk",
    "source_url": "https://www.legislation.gov.uk/uksi/2008/552/schedule/1/paragraph/14",
    "retrieved_at": "2026-10-29T03:35:25.906399+00:00"
  },
  "licence": "Open Government Licence v3.0",
  "licence_url": "https://www.nationalarchives.gov.uk/doc/open-government-licence/version/3/",
  "attribution": "Contains public sector information licensed under the Open Government Licence v3.0. Source: legislation.gov.uk, The National Archives."
}