SCHEDULEAmendments to Regulations on Supplementary Protection Certificates

PART 2Amendments to Regulation (EC) 469/2009

Article 5: effects of the certificate

13.

In Article 5—

(a)

In paragraph 1, after “Article 4”, insert “and paragraphs 1a and 1b”;

(b)

after paragraph 1, insert—

“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 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 the territory of England and Wales and Scotland or the territory of Northern Ireland as the case may be.”;

(c)

in paragraph 6—

(i)

insert “prescribed” before “form”;

(ii)

omit the words from “for” to the end.