Regulation (EC) No 469/2009 of the European Parliament and of the CouncilShow full title

[F1 Article 5 U.K. Effects of the certificate

1. Subject to the provisions of Article 4 [F2 and paragraphs 1a and 1b], the certificate shall confer the same rights as conferred by the basic patent and shall be subject to the same limitations and the same obligations.

[F3 1a. The protection conferred by a certificate in accordance with paragraph 1 shall extend only to the territory in respect of which a valid, UK, GB or NI authorisation has been issued and where the authorisation—

(a) is the first authorisation for the product in the territory in accordance with Article 3(b) and (d), and

(b) has been issued before the certificate takes effect in accordance with Article 13(1).

1b. Where after the submission of an application for a certificate in accordance with Article 7(1) or (2) and before the certificate takes effect in accordance with Article 13(1), a [F4 UK,] GB or NI authorisation is granted in respect of the same product and the authorisation would have met the requirements of Article 3(b) and (d) had it been granted on the date of submission of the application, the protection conferred by a certificate in accordance with paragraph 1 shall extend to [F5 the territory of the United Kingdom,] the territory of England and Wales and Scotland or the territory of Northern Ireland as the case may be.]

[F6 1c. Where after the submission of an application for a certificate in accordance with Article 7(1) or (2) in respect of a GB authorisation and before the certificate takes effect in accordance with Article 13(1), that authorisation becomes a transitioned-UK authorisation, the protection conferred by a certificate in accordance with paragraph 1 shall extend to the territory of England and Wales, Scotland and Northern Ireland.]

2. By way of derogation from paragraph 1, the certificate referred to in paragraph 1 shall not confer protection against certain acts which would otherwise require the consent of the holder of the certificate (‘the certificate holder’), if the following conditions are met:

(a) the acts comprise:

(i)

the making of a product, or a medicinal product containing that product, for the purpose of export to F7 ... countries [F8 outside the United Kingdom, the Isle of Man and the Member States of the European Union]; or

(ii)

any related act that is strictly necessary for the making, in the [F9 United Kingdom], referred to in point (i), or for the actual export; or

(iii)

the making, no earlier than six months before the expiry of the certificate, of a product, or a medicinal product containing that product, for the purpose of storing it in the [F10 United Kingdom], in order to place that product, or a medicinal product containing that product, on the market of [F11 the United Kingdom, the Isle of Man or one or more Member States of the European Union] after the expiry of the corresponding certificate; or

(iv)

any related act that is strictly necessary for the making, in the [F12 United Kingdom], referred to in point (iii), or for the actual storing, provided that such related act is carried out no earlier than six months before the expiry of the certificate.

(b) the maker, through appropriate and documented means, notifies the [F13 comptroller], and informs the certificate holder, of the information listed in paragraph 5 of this Article no later than three months before the start date of the making in [F14 the United Kingdom], or no later than three months before the first related act, prior to that making, that would otherwise be prohibited by the protection conferred by [F15 that] certificate, whichever is the earlier;

(c) if the information listed in paragraph 5 of this Article changes, the maker notifies the [F16 comptroller] and informs the certificate holder, before those changes take effect;

(d) in the case of products, or medicinal products containing those products, made for the purpose of export to F17 ... countries [F18 outside the United Kingdom, the Isle of Man and the Member States of the European Union], the maker ensures that [F19 the words ‘UK export’ are affixed so as to be sufficiently clear and visible to the naked eye] to the outer packaging of the product, or the medicinal product containing that product, referred to in point (a)(i) of this paragraph, and, where feasible, to its immediate packaging;

(e) the maker complies with paragraph 9 of this Article F20 ....

3. The exception referred to in paragraph 2 shall not apply to any act or activity carried out for the import of products, or medicinal products containing those products, into the [F21 United Kingdom] merely for the purpose of repackaging, re-exporting or storing.

4. The information provided to the certificate holder for the purposes of points (b) and (c) of paragraph 2 shall be used exclusively for the purposes of verifying whether the requirements of this Regulation have been met and, where applicable, initiating legal proceedings for non-compliance.

5. The information to be provided by the maker for the purposes of point (b) of paragraph 2 shall be as follows:

(a) the name and address of the maker;

(b) an indication of whether the making is for the purpose of export, for the purpose of storing, or for the purpose of both export and storing;

F22 (c) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

(d) the number of the certificate F23 ...; and

(e) for medicinal products to be exported to F24 ... countries [F25 outside the United Kingdom, the Isle of Man and the Member States of the European Union], the reference number of the marketing authorisation, or the equivalent of such authorisation, in each F24 ... country of export, as soon as it is publicly available.

6. For the purposes of notification to the [F26 comptroller] under points (b) and (c) of paragraph 2, the maker shall use the standard [F27 prescribed] form F28 ....

7. Failure to comply with the requirements of point (e) of paragraph 5 with regard to a F29 ... country [F30 outside the United Kingdom, the Isle of Man and the Member States of the European Union] shall only affect exports to that country, and those exports shall, therefore, not benefit from the exception.

F31 8. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

9. The maker shall ensure, through appropriate and documented means, that any person in a contractual relationship with the maker who performs acts falling under point (a) of paragraph 2 is fully informed and aware of the following:

(a) that those acts are subject to paragraph 2;

(b) that the placing on the market, import or re-import of the product, or the medicinal product containing that product, referred to in point (a)(i) of paragraph 2 or the placing on the market of the product, or the medicinal product containing that product, referred to in point (a)(iii) of paragraph 2 could infringe the certificate referred to in paragraph 2 where, and for as long as, that certificate applies.

10. Paragraph 2 shall apply to certificates that are applied for on or after 1 July 2019.

Paragraph 2 shall also apply to certificates that have been applied for before 1 July 2019 and that take effect on or after that date. Paragraph 2 shall only apply to such certificates from 2 July 2022.

Paragraph 2 shall not apply to certificates that take effect before 1 July 2019.]

[F32 11. The Secretary of State may by regulations make further provision as to the manner and form (including design and colour) of affixing the words “UK export” to the outer packaging of the product, or the medicinal product containing that product, referred to in paragraph 2(a)(i) of this Article, and, where feasible, to its immediate packaging.

12 Those regulations are to be made by statutory instrument which is subject to annulment pursuant to a resolution of either House of Parliament.]

Textual Amendments

F1 Substituted by Regulation (EU) 2019/933 of the European Parliament and of the Council of 20 May 2019 amending Regulation (EC) No 469/2009 concerning the supplementary protection certificate for medicinal products (Text with EEA relevance).

F2 Words in Art. 5(1) inserted (31.12.2020) by The Supplementary Protection Certificates (Amendment) (EU Exit) Regulations 2020 (S.I. 2020/1471), reg. 1(2), Sch. para. 13(a) (with reg. 7)

F3 Art. 5(1a)(1b) inserted (31.12.2020) by The Supplementary Protection Certificates (Amendment) (EU Exit) Regulations 2020 (S.I. 2020/1471), reg. 1(2), Sch. para. 13(b) (with reg. 7)

F4 Word in Art. 5(1b) inserted (1.1.2025) by The Supplementary Protection Certificates (Amendments Relating to the Windsor Framework) Regulations 2024 (S.I. 2024/1075), regs. 1(1), 4(a)

F5 Words in Art. 5(1b) inserted (1.1.2025) by The Supplementary Protection Certificates (Amendments Relating to the Windsor Framework) Regulations 2024 (S.I. 2024/1075), regs. 1(1), 4(b)

F6 Art. 5(1c) inserted (1.1.2025) by The Supplementary Protection Certificates (Amendments Relating to the Windsor Framework) Regulations 2024 (S.I. 2024/1075), regs. 1(1), 4(c)

F7 Word in Art. 5(2)(a)(i) omitted (31.12.2020) by virtue of The Intellectual Property (Amendment etc.) (EU Exit) Regulations 2020 (S.I. 2020/1050), reg. 1(2), Sch. para. 3(a)(i)(aa) (with reg. 43)

F8 Words in Art. 5(2)(a)(i) inserted (31.12.2020) by The Intellectual Property (Amendment etc.) (EU Exit) Regulations 2020 (S.I. 2020/1050), reg. 1(2), Sch. para. 3(a)(i)(bb) (with reg. 43)

F9 Words in Art. 5(2)(a)(ii) substituted (31.12.2020) by The Intellectual Property (Amendment etc.) (EU Exit) Regulations 2020 (S.I. 2020/1050), reg. 1(2), Sch. para. 3(a)(ii) (with reg. 43)

F10 Words in Art. 5(2)(a)(iii) substituted (31.12.2020) by The Intellectual Property (Amendment etc.) (EU Exit) Regulations 2020 (S.I. 2020/1050), reg. 1(2), Sch. para. 3(a)(iii)(aa) (with reg. 43)

F11 Words in Art. 5(2)(a)(iii) substituted (31.12.2020) by The Intellectual Property (Amendment etc.) (EU Exit) Regulations 2020 (S.I. 2020/1050), reg. 1(2), Sch. para. 3(a)(iii)(bb) (with reg. 43)

F12 Words in Art. 5(2)(a)(iv) substituted (31.12.2020) by The Intellectual Property (Amendment etc.) (EU Exit) Regulations 2020 (S.I. 2020/1050), reg. 1(2), Sch. para. 3(a)(iv) (with reg. 43)

F13 Word in Art. 5(2)(b) substituted (31.12.2020) by The Intellectual Property (Amendment etc.) (EU Exit) Regulations 2020 (S.I. 2020/1050), reg. 1(2), Sch. para. 3(b)(i) (with reg. 43)

F14 Words in Art. 5(2)(b) substituted (31.12.2020) by The Intellectual Property (Amendment etc.) (EU Exit) Regulations 2020 (S.I. 2020/1050), reg. 1(2), Sch. para. 3(b)(ii) (with reg. 43)

F15 Word in Art. 5(2)(b) substituted (31.12.2020) by The Intellectual Property (Amendment etc.) (EU Exit) Regulations 2020 (S.I. 2020/1050), reg. 1(2), Sch. para. 3(b)(iii) (with reg. 43)

F16 Word in Art. 5(2)(c) substituted (31.12.2020) by The Intellectual Property (Amendment etc.) (EU Exit) Regulations 2020 (S.I. 2020/1050), reg. 1(2), Sch. para. 3(c) (with reg. 43)

F17 Word in Art. 5(2)(d) omitted (31.12.2020) by virtue of The Intellectual Property (Amendment etc.) (EU Exit) Regulations 2020 (S.I. 2020/1050), reg. 1(2), Sch. para. 3(d)(i) (with reg. 43)

F18 Words in Art. 5(2)(d) inserted (31.12.2020) by The Intellectual Property (Amendment etc.) (EU Exit) Regulations 2020 (S.I. 2020/1050), reg. 1(2), Sch. para. 3(d)(ii) (with reg. 43)

F19 Words in Art. 5(2)(d) substituted (31.12.2020) by The Intellectual Property (Amendment etc.) (EU Exit) Regulations 2020 (S.I. 2020/1050), reg. 1(2), Sch. para. 3(d)(iii) (with reg. 43)

F20 Words in Art. 5(2)(e) omitted (31.12.2020) by virtue of The Intellectual Property (Amendment etc.) (EU Exit) Regulations 2020 (S.I. 2020/1050), reg. 1(2), Sch. para. 3(e) (with reg. 43)

F21 Words in Art. 5(3) substituted (31.12.2020) by The Intellectual Property (Amendment etc.) (EU Exit) Regulations 2020 (S.I. 2020/1050), reg. 1(2), Sch. para. 3(f) (with reg. 43)

F22 Art. 5(5)(c) omitted (31.12.2020) by virtue of The Intellectual Property (Amendment etc.) (EU Exit) Regulations 2020 (S.I. 2020/1050), reg. 1(2), Sch. para. 3(g)(i) (with reg. 43)

F23 Word in Art. 5(5)(d) omitted (31.12.2020) by virtue of The Intellectual Property (Amendment etc.) (EU Exit) Regulations 2020 (S.I. 2020/1050), reg. 1(2), Sch. para. 3(g)(ii) (with reg. 43)

F24 Word in Art. 5(5)(e) omitted (31.12.2020) by virtue of The Intellectual Property (Amendment etc.) (EU Exit) Regulations 2020 (S.I. 2020/1050), reg. 1(2), Sch. para. 3(g)(iii)(aa) (with reg. 43)

F25 Words in Art. 5(5)(e) inserted (31.12.2020) by The Intellectual Property (Amendment etc.) (EU Exit) Regulations 2020 (S.I. 2020/1050), reg. 1(2), Sch. para. 3(g)(iii)(bb) (with reg. 43)

F26 Word in Art. 5(6) substituted (31.12.2020) by The Intellectual Property (Amendment etc.) (EU Exit) Regulations 2020 (S.I. 2020/1050), reg. 1(2), Sch. para. 3(h)(i) (with reg. 43)

F27 Word in Art. 5(6) inserted (31.12.2020) by The Supplementary Protection Certificates (Amendment) (EU Exit) Regulations 2020 (S.I. 2020/1471), reg. 1(2), Sch. para. 13(c)(i) (with reg. 7)

F28 Words in Art. 5(6) omitted (31.12.2020) by virtue of The Supplementary Protection Certificates (Amendment) (EU Exit) Regulations 2020 (S.I. 2020/1471), reg. 1(2), Sch. para. 13(c)(ii) (with reg. 7)

F29 Word in Art. 5(7) omitted (31.12.2020) by virtue of The Intellectual Property (Amendment etc.) (EU Exit) Regulations 2020 (S.I. 2020/1050), reg. 1(2), Sch. para. 3(i)(i) (with reg. 43)

F30 Words in Art. 5(7) inserted (31.12.2020) by The Intellectual Property (Amendment etc.) (EU Exit) Regulations 2020 (S.I. 2020/1050), reg. 1(2), Sch. para. 3(i)(ii) (with reg. 43)

F31 Art. 5(8) omitted (31.12.2020) by virtue of The Intellectual Property (Amendment etc.) (EU Exit) Regulations 2020 (S.I. 2020/1050), reg. 1(2), Sch. para. 3(j) (with reg. 43)

F32 Art. 5(11)(12) inserted (31.12.2020) by The Intellectual Property (Amendment etc.) (EU Exit) Regulations 2020 (S.I. 2020/1050), reg. 1(2), Sch. para. 3(k) (with reg. 43)