{
  "url": "https://openlegislation.uk/draft-medical-devices-northern-ireland-protocol-regulations-2021/regulation-41",
  "json_url": "https://openlegislation.uk/draft-medical-devices-northern-ireland-protocol-regulations-2021/regulation-41.json",
  "legislation": "ukdsi/2021/9780348224740",
  "legislation_title": "The Medical Devices (Northern Ireland Protocol) Regulations 2021",
  "legislation_url": "https://openlegislation.uk/draft-medical-devices-northern-ireland-protocol-regulations-2021",
  "path": "regulation/41",
  "kind": "regulation",
  "number": "41",
  "heading": "Amendment of the Medicines (Products for Human Use) (Fees) Regulations 2016",
  "text": "In the Medicines (Products for Human Use) (Fees) Regulations 2016, in regulation 10(5) (fee for advice for other purposes)—\n(a) in paragraph (a), omit the “or” at the end; and\n(b) in paragraph (b), at the end insert—\n“; or\n(c) obtaining an EU technical documentation assessment certificate or EU type-examination certificate of the type mentioned in section 5 of Annex IX and section 6 of Annex X of Regulation (EU) 2017/745 of the European Parliament and of the Council of 5 April 2017 on medical devices, amending Directive 2001/83/EC, Regulation (EC) No 178/2002 and Regulation (EC) No 1223/2009 and repealing Council Directives 90/385/EEC and 93/42/EEC, for a medical device incorporating that product or a product of that type.”",
  "extent": null,
  "status": null,
  "version": "current",
  "annotations": [
    {
      "type": "footnote",
      "label": "f1",
      "text": "S.I. 2016/190, amended by S.I. 2019/775; there are other amending instruments but none is relevant."
    }
  ],
  "outstanding_effects": [],
  "provenance": {
    "source": "legislation.gov.uk",
    "source_url": "https://www.legislation.gov.uk/ukdsi/2021/9780348224740/regulation/41",
    "retrieved_at": "2026-10-30T14:46:58.636532+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."
}