Regulation 55 I1

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

For paragraph 1(a)(iv), substitute—

“F1(iv)

the number and date of the UK, GB or NI authorisation, or where there is more than one such authorisation, of each authorisation as referred to in Article 3(b) and (d);

(v)

the number and date of the earliest of any EEA authorisation, the granting of which predates the granting of the UK F2, GB or NI authorisation F3as referred to in Article 3(b) and (d);”.

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

“(b)

a copy of the UK F4, GB or NI authorisation or, where there is more than one such authorisation, of each authorisation to place the product on the market, as referred to in Article 3(b) F5and (d), in which the product is identified, containing in particular the number and date of the authorisation and the summary of the product characteristics listed in Article 11 of Directive 2001/83/EC, Article 14 of Directive 2001/82/EC, Part 2 to Schedule 8 of the Human Medicines Regulations 2012 or Part 1 of Schedule 1 to the Veterinary Medicines Regulations 2013;

(c)

where the product is the subject of one or more EEA authorisations granted prior to the UK F6, GB or NI authorisation referred to in Article 3(b) F7and (d), the applicant must provide in relation to the earliest of any such EEA authorisations—

(i)

information regarding the identity of the product thus authorised;

(ii)

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

(iii)

a copy of the notice publishing the authorisation in the appropriate official publication;”.

In paragraph 1(d)—

Omit paragraph (4).