{
  "url": "https://openlegislation.uk/eu-regulation-2014-658",
  "json_url": "https://openlegislation.uk/eu-regulation-2014-658.json",
  "id": "eur/2014/658",
  "title": "Regulation (EU) No 658/2014 of the European Parliament and of the Council of 15 May 2014 on fees payable to the European Medicines Agency for the conduct of pharmacovigilance activities in respect of medicinal products for human use (Text with EEA relevance) (revoked)",
  "short_title": "Regulation (EU) No 658/2014 on fees payable to the European Medicines Agency for the conduct of…",
  "long_title": "Regulation (EU) No 658/2014 of the European Parliament and of the Council of 15 May 2014 on fees payable to the European Medicines Agency for the conduct of pharmacovigilance activities in respect of medicinal products for human use (Text with EEA relevance)",
  "citation": "EU Regulation No 658/2014",
  "type": "eur",
  "year": "2014",
  "number": "658",
  "version": "current",
  "date": "2014-05-15",
  "revised": false,
  "valid_from": null,
  "extent": "E+W+S+N.I.",
  "unapplied_effects": 0,
  "provisions": [
    {
      "path": "introduction",
      "kind": "introduction",
      "number": null,
      "heading": "Introductory text",
      "url": "https://openlegislation.uk/eu-regulation-2014-658/introduction",
      "extent": "E+W+S+N.I.",
      "status": null,
      "parent": null
    },
    {
      "path": "article/1",
      "kind": "article",
      "number": "1",
      "heading": "Subject matter and scope",
      "url": "https://openlegislation.uk/eu-regulation-2014-658/article-1",
      "extent": "E+W+S+N.I.",
      "status": "repealed",
      "parent": null
    },
    {
      "path": "article/2",
      "kind": "article",
      "number": "2",
      "heading": "Definitions",
      "url": "https://openlegislation.uk/eu-regulation-2014-658/article-2",
      "extent": "E+W+S+N.I.",
      "status": "repealed",
      "parent": null
    },
    {
      "path": "article/3",
      "kind": "article",
      "number": "3",
      "heading": "Types of fees",
      "url": "https://openlegislation.uk/eu-regulation-2014-658/article-3",
      "extent": "E+W+S+N.I.",
      "status": "repealed",
      "parent": null
    },
    {
      "path": "article/4",
      "kind": "article",
      "number": "4",
      "heading": "Fee for assessment of periodic safety update reports",
      "url": "https://openlegislation.uk/eu-regulation-2014-658/article-4",
      "extent": "E+W+S+N.I.",
      "status": "repealed",
      "parent": null
    },
    {
      "path": "article/5",
      "kind": "article",
      "number": "5",
      "heading": "Fee for assessment of post-authorisation safety studies",
      "url": "https://openlegislation.uk/eu-regulation-2014-658/article-5",
      "extent": "E+W+S+N.I.",
      "status": "repealed",
      "parent": null
    },
    {
      "path": "article/6",
      "kind": "article",
      "number": "6",
      "heading": "Fee for assessments in the context of referrals initiated as a result of the evaluation of pharmacovigilance data",
      "url": "https://openlegislation.uk/eu-regulation-2014-658/article-6",
      "extent": "E+W+S+N.I.",
      "status": "repealed",
      "parent": null
    },
    {
      "path": "article/7",
      "kind": "article",
      "number": "7",
      "heading": "Annual fee for information technology systems and literature monitoring",
      "url": "https://openlegislation.uk/eu-regulation-2014-658/article-7",
      "extent": "E+W+S+N.I.",
      "status": "repealed",
      "parent": null
    },
    {
      "path": "article/8",
      "kind": "article",
      "number": "8",
      "heading": "Fee reductions and fee exemption",
      "url": "https://openlegislation.uk/eu-regulation-2014-658/article-8",
      "extent": "E+W+S+N.I.",
      "status": "repealed",
      "parent": null
    },
    {
      "path": "article/9",
      "kind": "article",
      "number": "9",
      "heading": "Payment of remuneration by the Agency to national competent authorities",
      "url": "https://openlegislation.uk/eu-regulation-2014-658/article-9",
      "extent": "E+W+S+N.I.",
      "status": "repealed",
      "parent": null
    },
    {
      "path": "article/10",
      "kind": "article",
      "number": "10",
      "heading": "Method of payment of the fee",
      "url": "https://openlegislation.uk/eu-regulation-2014-658/article-10",
      "extent": "E+W+S+N.I.",
      "status": "repealed",
      "parent": null
    },
    {
      "path": "article/11",
      "kind": "article",
      "number": "11",
      "heading": "Identification of the payment of the fee",
      "url": "https://openlegislation.uk/eu-regulation-2014-658/article-11",
      "extent": "E+W+S+N.I.",
      "status": "repealed",
      "parent": null
    },
    {
      "path": "article/12",
      "kind": "article",
      "number": "12",
      "heading": "Date of payment of the fee",
      "url": "https://openlegislation.uk/eu-regulation-2014-658/article-12",
      "extent": "E+W+S+N.I.",
      "status": "repealed",
      "parent": null
    },
    {
      "path": "article/13",
      "kind": "article",
      "number": "13",
      "heading": "Refund of fee amounts paid in excess",
      "url": "https://openlegislation.uk/eu-regulation-2014-658/article-13",
      "extent": "E+W+S+N.I.",
      "status": "repealed",
      "parent": null
    },
    {
      "path": "article/14",
      "kind": "article",
      "number": "14",
      "heading": "Provisional estimate of Agency budget",
      "url": "https://openlegislation.uk/eu-regulation-2014-658/article-14",
      "extent": "E+W+S+N.I.",
      "status": "repealed",
      "parent": null
    },
    {
      "path": "article/15",
      "kind": "article",
      "number": "15",
      "heading": "Transparency and monitoring",
      "url": "https://openlegislation.uk/eu-regulation-2014-658/article-15",
      "extent": "E+W+S+N.I.",
      "status": "repealed",
      "parent": null
    },
    {
      "path": "article/16",
      "kind": "article",
      "number": "16",
      "heading": "Exercise of the delegation",
      "url": "https://openlegislation.uk/eu-regulation-2014-658/article-16",
      "extent": "E+W+S+N.I.",
      "status": "repealed",
      "parent": null
    },
    {
      "path": "article/17",
      "kind": "article",
      "number": "17",
      "heading": "Transitional provisions",
      "url": "https://openlegislation.uk/eu-regulation-2014-658/article-17",
      "extent": "E+W+S+N.I.",
      "status": "repealed",
      "parent": null
    },
    {
      "path": "article/18",
      "kind": "article",
      "number": "18",
      "heading": "Entry into force and application",
      "url": "https://openlegislation.uk/eu-regulation-2014-658/article-18",
      "extent": "E+W+S+N.I.",
      "status": "repealed",
      "parent": null
    },
    {
      "path": "signature",
      "kind": "signature",
      "number": null,
      "heading": "Signature",
      "url": "https://openlegislation.uk/eu-regulation-2014-658/signature",
      "extent": "E+W+S+N.I.",
      "status": null,
      "parent": null
    },
    {
      "path": "annex",
      "kind": "annex",
      "number": null,
      "heading": null,
      "url": null,
      "extent": "E+W+S+N.I.",
      "status": "repealed",
      "parent": null
    },
    {
      "path": "annex/part/I",
      "kind": "part",
      "number": "I",
      "heading": "FEE FOR ASSESSMENT OF PERIODIC SAFETY UPDATE REPORTS REFERRED TO IN ARTICLE 4",
      "url": null,
      "extent": "E+W+S+N.I.",
      "status": "repealed",
      "parent": "annex"
    },
    {
      "path": "annex/part/I/division/1",
      "kind": "division",
      "number": "1",
      "heading": null,
      "url": "https://openlegislation.uk/eu-regulation-2014-658/annex/part-I/division-1",
      "extent": "E+W+S+N.I.",
      "status": "repealed",
      "parent": "annex/part/I"
    },
    {
      "path": "annex/part/I/division/2",
      "kind": "division",
      "number": "2",
      "heading": "For the purpose of calculating the amount to be levied on each marketing authorisation holder in application of Article 4(4), the Agency shall calculate the proportion of chargeable units held by each marketing authorisation holder concerned of the total number of chargeable units held by all marketing authorisation holders involved in the procedure.",
      "url": "https://openlegislation.uk/eu-regulation-2014-658/annex/part-I/division-2",
      "extent": "E+W+S+N.I.",
      "status": "repealed",
      "parent": "annex/part/I"
    },
    {
      "path": "annex/part/I/division/3",
      "kind": "division",
      "number": "3",
      "heading": null,
      "url": "https://openlegislation.uk/eu-regulation-2014-658/annex/part-I/division-3",
      "extent": "E+W+S+N.I.",
      "status": "repealed",
      "parent": "annex/part/I"
    },
    {
      "path": "annex/part/I/division/4",
      "kind": "division",
      "number": "4",
      "heading": null,
      "url": "https://openlegislation.uk/eu-regulation-2014-658/annex/part-I/division-4",
      "extent": "E+W+S+N.I.",
      "status": "repealed",
      "parent": "annex/part/I"
    },
    {
      "path": "annex/part/II",
      "kind": "part",
      "number": "II",
      "heading": "FEE FOR ASSESSMENT OF A POST-AUTHORISATION SAFETY STUDIES REFERRED TO IN ARTICLE 5",
      "url": null,
      "extent": "E+W+S+N.I.",
      "status": "repealed",
      "parent": "annex"
    },
    {
      "path": "annex/part/II/division/1",
      "kind": "division",
      "number": "1",
      "heading": "The fee for the assessment of each post-authorisation safety study shall be EUR 45 810 to be paid in two instalments as follows:",
      "url": "https://openlegislation.uk/eu-regulation-2014-658/annex/part-II/division-1",
      "extent": "E+W+S+N.I.",
      "status": "repealed",
      "parent": "annex/part/II"
    },
    {
      "path": "annex/part/II/division/2",
      "kind": "division",
      "number": "2",
      "heading": null,
      "url": "https://openlegislation.uk/eu-regulation-2014-658/annex/part-II/division-2",
      "extent": "E+W+S+N.I.",
      "status": "repealed",
      "parent": "annex/part/II"
    },
    {
      "path": "annex/part/II/division/3",
      "kind": "division",
      "number": "3",
      "heading": null,
      "url": "https://openlegislation.uk/eu-regulation-2014-658/annex/part-II/division-3",
      "extent": "E+W+S+N.I.",
      "status": "repealed",
      "parent": "annex/part/II"
    },
    {
      "path": "annex/part/II/division/4",
      "kind": "division",
      "number": "4",
      "heading": null,
      "url": "https://openlegislation.uk/eu-regulation-2014-658/annex/part-II/division-4",
      "extent": "E+W+S+N.I.",
      "status": "repealed",
      "parent": "annex/part/II"
    },
    {
      "path": "annex/part/III",
      "kind": "part",
      "number": "III",
      "heading": "FEE FOR ASSESSMENT IN THE CONTEXT OF REFERRALS INITIATED AS A RESULT OF THE EVALUATION OF PHARMACOVIGILANCE DATA REFERRED TO IN ARTICLE 6",
      "url": null,
      "extent": "E+W+S+N.I.",
      "status": "repealed",
      "parent": "annex"
    },
    {
      "path": "annex/part/III/division/1",
      "kind": "division",
      "number": "1",
      "heading": "The fee for the assessment of the procedure referred to in Article 6(1) shall be EUR 190 740 where one or two active substances and/or combinations of active substances are included in the assessment. That fee shall be increased by EUR 41 350 per each additional active substance or combination of active substances as of the third active substance or combination of substances. That fee shall not exceed EUR 314 790 irrespective of the number of active substances and/or combinations of active substances.",
      "url": "https://openlegislation.uk/eu-regulation-2014-658/annex/part-III/division-1",
      "extent": "E+W+S+N.I.",
      "status": "repealed",
      "parent": "annex/part/III"
    },
    {
      "path": "annex/part/III/division/2",
      "kind": "division",
      "number": "2",
      "heading": "For the purpose of calculating the amount to be levied on each marketing authorisation holder in application of Article 6(4), the Agency shall calculate the proportion of chargeable units held by each marketing authorisation holder concerned of the total number of chargeable units held by all marketing authorisation holders involved in the procedure.",
      "url": "https://openlegislation.uk/eu-regulation-2014-658/annex/part-III/division-2",
      "extent": "E+W+S+N.I.",
      "status": "repealed",
      "parent": "annex/part/III"
    },
    {
      "path": "annex/part/III/division/3",
      "kind": "division",
      "number": "3",
      "heading": "In application of Article 6(5), the amount payable by the marketing authorisation holder shall be two thirds of the applicable fee laid down in point 1 of this Part. Small and medium-sized enterprises shall pay 60 % of that amount.",
      "url": "https://openlegislation.uk/eu-regulation-2014-658/annex/part-III/division-3",
      "extent": "E+W+S+N.I.",
      "status": "repealed",
      "parent": "annex/part/III"
    },
    {
      "path": "annex/part/III/division/4",
      "kind": "division",
      "number": "4",
      "heading": null,
      "url": "https://openlegislation.uk/eu-regulation-2014-658/annex/part-III/division-4",
      "extent": "E+W+S+N.I.",
      "status": "repealed",
      "parent": "annex/part/III"
    },
    {
      "path": "annex/part/IV",
      "kind": "part",
      "number": "IV",
      "heading": "ANNUAL FEE FOR INFORMATION TECHNOLOGY SYSTEMS AND LITERATURE MONITORING REFERRED TO IN ARTICLE 7",
      "url": null,
      "extent": "E+W+S+N.I.",
      "status": "repealed",
      "parent": "annex"
    },
    {
      "path": "annex/part/IV/division/1",
      "kind": "division",
      "number": "1",
      "heading": null,
      "url": "https://openlegislation.uk/eu-regulation-2014-658/annex/part-IV/division-1",
      "extent": "E+W+S+N.I.",
      "status": "repealed",
      "parent": "annex/part/IV"
    },
    {
      "path": "annex/part/IV/division/2",
      "kind": "division",
      "number": "2",
      "heading": null,
      "url": "https://openlegislation.uk/eu-regulation-2014-658/annex/part-IV/division-2",
      "extent": "E+W+S+N.I.",
      "status": "repealed",
      "parent": "annex/part/IV"
    },
    {
      "path": "annex/part/IV/division/3",
      "kind": "division",
      "number": "3",
      "heading": null,
      "url": "https://openlegislation.uk/eu-regulation-2014-658/annex/part-IV/division-3",
      "extent": "E+W+S+N.I.",
      "status": "repealed",
      "parent": "annex/part/IV"
    },
    {
      "path": "annex/part/V",
      "kind": "part",
      "number": "V",
      "heading": "PERFORMANCE INFORMATION",
      "url": "https://openlegislation.uk/eu-regulation-2014-658/annex/part-V",
      "extent": "E+W+S+N.I.",
      "status": "repealed",
      "parent": "annex"
    }
  ],
  "outstanding_effects": [],
  "made_under": [],
  "changes_made_to": 1,
  "changes_made_to_url": "https://openlegislation.uk/eu-regulation-2014-658/changes.json",
  "changes_made_by": 0,
  "changes_made_by_url": "https://openlegislation.uk/eu-regulation-2014-658/changes/by-it.json",
  "instruments_made_under": 0,
  "instruments_made_under_url": "https://openlegislation.uk/eu-regulation-2014-658/instruments.json",
  "provenance": {
    "source": "legislation.gov.uk",
    "source_url": "https://www.legislation.gov.uk/eur/2014/658",
    "retrieved_at": "2026-11-01T14:47:32.831130+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."
}