PART 8SUPPLEMENTARY PROTECTION CERTIFICATES FOR MEDICINAL PRODUCTS – AMENDMENTS TO REGULATION (EC) No 469/2009

I156

1

Article 9 (lodging of an application for a certificate) is amended as follows.

2

For paragraph 1 substitute—

1

An application for a certificate (or an extension of the duration of a certificate) shall be lodged with the comptroller.

3

In the introductory words of paragraph 2, for “the authority referred to in paragraph 1”, substitute “ the comptroller ”.

4

For sub-paragraphs (d) and (e) of paragraph 2, substitute—

F1d

the number and date of the UK, GB or NI authorisation or, where there is more than one such authorisation, each authorisation provided under Article 8(1)(b), the product identified in the authorisation or each authorisation and the territory in respect of which the authorisation has been granted or has effect as if granted;

e

where there are authorisations granted in the EEA before F2any UK, GB or NI authorisation provided under Article 8(1)(b), the number and date of the earliest EEA authorisation;