Article 1 Definitions

For the purposes of this Regulation, the following definitions shall apply:

1. (a)

   ‘medicinal product’ means any substance or combination of substances presented for treating or preventing disease in human beings or animals and any substance or combination of substances which may be administered to human beings or animals with a view to making a medical diagnosis or to restoring, correcting or modifying physiological functions in humans or in animals;

2. (b)

   ‘product’ means the active ingredient or combination of active ingredients of a medicinal product;

3. (c)

   ‘basic patent’ means a patent which protects a product as such, a process to obtain a product or an application of a product, and which is designated by its holder for the purpose of the procedure for grant of a certificate;

4. (d)

   ‘certificate’ means the supplementary protection certificate;

5. (e)

   ‘application for an extension of the duration’ means an application for an extension of the duration of the certificate pursuant to Article 13(3) of this Regulation and F1regulation 58A(3) of the Human Medicines Regulations 2012;

6. (f)

   F2‘comptroller’ means the Comptroller-General of Patents, Designs and Trade Marks;

7. (g)

   ‘court’ means—

   1. (i)

      as respects England and Wales, the High Court;

   2. (ii)

      as respects Scotland, the Court of Session;

   3. (iii)

      as respects Northern Ireland, the High Court in Northern Ireland;

8. (ga)

   F3“Windsor Framework” means the part of the EU withdrawal agreement known as the Windsor Framework by virtue of Joint Declaration No. 1/2023 of 24 March 2023 made between the European Union and the United Kingdom in the Joint Committee established by the EU withdrawal agreement;

9. (h)

   “EEA authorisation” means an authorisation to place a medicinal product on the market which has effect in an EEA state in accordance with F4Directive 2001/83/EC, Directive 2001/82/EC or Regulation (EU) 2019/6;

10. (i)

    ‘patent’ means a patent which has effect in the United Kingdom;

11. (j)

    ‘UK authorisation’ means, in relation to a product, an authorisation to place that product on the market in the United Kingdom as a medicinal product granted or having effect as if granted in accordance with—

    1. (i)

       Part 5 of the Human Medicines Regulations 2012; or

    2. (ii)

       regulation 4(3) of, and Schedule 1 to, the Veterinary Medicines Regulations 2013.

12. (ja)

    F5“GB authorisation” means, in relation to a product, an authorisation to place that product on the market in England and Wales and Scotland as a medicinal product granted or having effect as if granted in accordance with—

    1. (i)

       Part 5 of the Human Medicines Regulations 2012; or

    2. (ii)

       regulation 4(3) of, and Schedule 1 to, the Veterinary Medicines Regulations 2013 as they have effect in England and Wales and Scotland;

13. (jaa)

    F6“transitioned-UK authorisation” means a GB authorisation for a medicinal product in force immediately before 1 January 2025 which, pursuant to Schedule 33B to the Human Medicines Regulations 2012 , has effect on and after that date as a UK authorisation;

14. (jb)

    “NI authorisation” means, in relation to a product, an authorisation to place that product on the market in Northern Ireland as a medicinal product granted or having effect as if granted in accordance with Directive 2001/83/EC F7, Directive 2001/82/EC or Regulation (EU) 2019/6 as they have effect by virtue of the Windsor Framework;

15. (jc)

    F8“former NI authorisation” means a NI authorisation for a medicinal product for human use that is prohibited from being placed on the market in Northern Ireland by Article 4(1) of Regulation (EU) 2023/1182 of the European Parliament and of the Council of 14 June 2023 on specific rules relating to medicinal products for human use intended to be placed on the market in Northern Ireland and amending Directive 2001/83/EC;

16. (k)

    F9F10‘maker’ means the person, established in the F11United Kingdom, on whose behalf the making of a product, or a medicinal product containing that product, for the purpose of export to F12... countries F13outside the United Kingdom, the Isle of Man and the Member States of the European Union or for the purpose of storing, is carried out.

17. (l)

    F14“prescribed” means prescribed by rules under section 123 of the Patents Act 1977.