Regulation 24 I1

Article 8 (contents of the application for a certificate) is amended as follows.

For paragraph 1(a)(iv), substitute—

“(iv)

the number and date of the F1GB or NI authorisation or both GB and NI authorisations as referred to in Article 3(1)(b) F2and (d); and

(v)

the number and date of the earliest EEA authorization, the granting of which predates the granting of the F3GB or NI authorization F4as referred to in Article 3(1)(b) and (d);”.

For paragraph 8(1)(b) and (c), substitute—

“(b)

a copy of the F5GB or NI authorisation or both GB and NI authorisations to place the product on the market, as referred to in Article 3(1)(b) F6and (d), in which the product is identified, containing in particular the number and date of the authorization and the summary of the product characteristics listed in Commission Regulation 283/2013, F7Part A section 1, points 1.1 to 1.7 or Part B, Section 1 points 1.1 to 1.4.3;

(c)

where the product is the subject of one or more EEA authorizations granted prior to the F8GB or NI authorization referred to in Article 3(1)(b) F9and (d), the applicant must provide in relation to the earliest of any such EEA authorizations—

(i)

information regarding the identity of the product thus authorised;

(ii)

information regarding the legal provision under which the authorization procedure took place; and

(iii)

a copy of the notice publishing the authorization in the appropriate official publication or, failing such a notice, any other document proving that the authorization has been issued, the date on which it was issued and the identity of the product authorized.”.

Omit paragraph 2.