{
  "url": "https://openlegislation.uk/draft-supplementary-protection-certificates-amendment-eu-exit-regulations-2020/schedule/paragraph-19",
  "json_url": "https://openlegislation.uk/draft-supplementary-protection-certificates-amendment-eu-exit-regulations-2020/schedule/paragraph-19.json",
  "legislation": "ukdsi/2020/9780348213645",
  "legislation_title": "The Supplementary Protection Certificates (Amendment) (EU Exit) Regulations 2020",
  "legislation_url": "https://openlegislation.uk/draft-supplementary-protection-certificates-amendment-eu-exit-regulations-2020",
  "path": "schedule/paragraph/19",
  "kind": "paragraph",
  "number": "19",
  "heading": "Article 13A: authorisation granted after submission of an application for a certificate",
  "text": "After Article 13, insert—\n“Article 13A\nAuthorisation granted after submission of an application for a certificate\n1. Where after the date of submission of an application under Article 7(1) or (2), but before the grant of a certificate under Article 10(1) in relation to a NI authorisation, a valid UK or GB authorisation is granted which, at its date of grant, is the first authorisation to place the product on the market as a medicinal product in the territory of the United Kingdom or the territory of England and Wales and Scotland as the case may be, the applicant shall notify the comptroller of the grant of the authorisation, within six months of its date of grant and before the certificate takes effect under Article 13(1), and provide the details set out in Article 8(1)(a)(iv) and (b) on the prescribed form.\n2. Where after the submission of an application under Article 7(1) or (2), but before the grant of a certificate under Article 10(1) in relation to a UK or GB authorisation, a valid NI authorisation is granted which, at its date of grant, is the first authorisation to place the product on the market as a medicinal product in the territory of Northern Ireland, the applicant shall notify the comptroller of the grant of the authorisation, within six months of its date of grant and before the certificate takes effect under Article 13(1), and provide the details set out in Article 8(1)(a)(iv) and (b) on the prescribed form.\n3. Where after the grant of a certificate under Article 10(1) in relation to a UK or GB authorisation, but before expiry of the basic patent, a valid NI authorisation is granted which, at its date of grant, is the first authorisation to place the product on the market as a medicinal product in the territory of Northern Ireland, the certificate holder shall notify the comptroller of the grant of the authorisation, within six months of its date of grant and before the certificate takes effect under Article 13(1), and provide the details set out in Article 8(1)(a)(iv) and (b) on the prescribed form.\n4. Where after the grant of a certificate under Article 10(1) in relation to a NI authorisation, but before expiry of the basic patent, a valid UK or GB authorisation is granted which, at its date of grant, is the first authorisation to place the product on the market as a medicinal product in the territory of the United Kingdom or the territory of England and Wales and Scotland as the case may be, the certificate holder shall notify the comptroller of the grant of the NI authorisation, within six months of its date of grant and before the certificate takes effect under Article 13(1), and provide the details set out in Article 8(1)(a)(iv) and (b) on the prescribed form.\n5. If the applicant or the certificate holder fails to notify the comptroller of the grant of an authorisation in accordance with paragraph 1, 2, 3 or 4 the protection conferred by a certificate granted under Article 10 shall not extend to any additional territory covered by that authorisation.\n6. On receipt of a notification under any of paragraphs 1 to 4, the comptroller shall publish:\n(a) the number and date of the authorisation,\n(b) the product identified in that authorisation, and\n(c) the territory in respect of which the authorisation has been granted or has effect as if granted.\nArticle 13B\nExtension of the duration of a certificate\n1. Where after an application for an extension of the duration of a certificate in accordance with Article 7(3) or (4) has been made in respect of a GB authorisation, but before the application is granted, an application is also made for an extension of the duration of the certificate in respect of a NI authorisation in accordance with Article 7(3) or (4), the duration of the certificate, if the extension is granted, shall be extended in accordance with Article 13(3) and (5) to include the territory of Northern Ireland.\n2. Where after an application for an extension of the duration of a certificate in accordance with Article 7(3) or (4) has been made in respect of a NI authorisation, but before the application is granted, an application is also made for an extension of the duration of the certificate in respect of a GB authorisation in accordance with Article 7(3) or (4), the duration of the certificate shall be extended in accordance with Article 13(3) and (5) to include the territory of England and Wales and Scotland.\n3. Where after the grant in accordance with Article 10(6) of an application for an extension of the duration of a certificate in respect of a GB authorisation, an application is made, in accordance with Article 7(4), for an extension of the certificate in respect of a NI authorisation, the duration of the certificate shall be extended in accordance with Article 13(3) and (5) to include the territory of Northern Ireland.\n4. Where after the grant, in accordance with Article 10(6) of an application for an extension of the duration of a certificate in respect of a NI authorisation, an application is made, in accordance with Article 7(4), for an extension of the certificate in relation to a GB authorisation, the duration of the certificate shall be extended in accordance with Article 13(3) and (5) to include the territory of England and Wales and Scotland.”.",
  "extent": null,
  "status": null,
  "version": "current",
  "annotations": [],
  "outstanding_effects": [],
  "provenance": {
    "source": "legislation.gov.uk",
    "source_url": "https://www.legislation.gov.uk/ukdsi/2020/9780348213645/schedule/paragraph/19",
    "retrieved_at": "2026-10-30T14:48:38.771366+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."
}